Study of Durvalumab Given with Chemoradiation Therapy in Patients with Unresectable Non-small Cell Lung Cancer

Study identifier:D933KC00001

ClinicalTrials.gov identifier:NCT03519971

EudraCT identifier:2017-004397-34

CTIS identifier:2024-515321-29-00

Recruitment Complete

Official Title

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently with Platinum-based Chemoradiation Therapy in Patients with Locally Advanced, Unresectable NSCLC (Stage III) (PACIFIC2)

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Durvalumab, Cisplatin/ Etoposide, Carboplatin/ Paclitaxel, Pemetrexed/ Cisplatin, Pemetrexed/ Carboplatin

Sex

All

Actual Enrollment

328

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Mar 2018

Primary Completion Date: 07 Sept 2023

Estimated Study Completion Date: 31 Mar 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Bangkok, Thailand, 10330

Location

Research Site

Hat Yai, Thailand, 90110

Location

Research Site

Mueang, Thailand, 50200

Location

Research Site

Khon Kaen, Thailand, 40002

Location

Research Site

Bangkok, Thailand, 10400

Location

Research Site

Ankara, Turkey

Location

Research Site

Antalya, Turkey, 07059

Location

Research Site

Izmir, Turkey, 35100

Arms	Assigned Interventions
Experimental: Arm 1: Durvalumab + platinum-based chemotherapy and radiation Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: - cisplatin/etoposide - carboplatin/paclitaxel - pemetrexed/cisplatin - pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.	Drug: Durvalumab Durvalumab IV (intravenous infusion) Other Name: MEDI4736 Drug: Cisplatin/ Etoposide Cisplatin/ Etoposide, as per standard of care Drug: Carboplatin/ Paclitaxel Carboplatin /Paclitaxel, as per standard of care Drug: Pemetrexed/ Cisplatin Pemetrexed / Cisplatin, as per standard of care Drug: Pemetrexed/ Carboplatin Pemetrexed / Carboplatin , as per standard of care Radiation: Radiation 5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)
Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy and radiation Placebo in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: - cisplatin/etoposide - carboplatin/paclitaxel - pemetrexed/cisplatin - pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive placebo as consolidation treatment.	Other: Placebo Placebo IV (intravenous infusion) Drug: Cisplatin/ Etoposide Cisplatin/ Etoposide, as per standard of care Drug: Carboplatin/ Paclitaxel Carboplatin /Paclitaxel, as per standard of care Drug: Pemetrexed/ Cisplatin Pemetrexed / Cisplatin, as per standard of care Drug: Pemetrexed/ Carboplatin Pemetrexed / Carboplatin , as per standard of care Radiation: Radiation 5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)

Arms

Assigned Interventions

Experimental: Arm 1: Durvalumab + platinum-based chemotherapy and radiation
Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: - cisplatin/etoposide - carboplatin/paclitaxel - pemetrexed/cisplatin - pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.

Drug: Durvalumab
Durvalumab IV (intravenous infusion)

Other Name: MEDI4736

Drug: Cisplatin/ Etoposide
Cisplatin/ Etoposide, as per standard of care

Drug: Carboplatin/ Paclitaxel
Carboplatin /Paclitaxel, as per standard of care

Drug: Pemetrexed/ Cisplatin
Pemetrexed / Cisplatin, as per standard of care

Drug: Pemetrexed/ Carboplatin
Pemetrexed / Carboplatin , as per standard of care

Radiation: Radiation
5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)

Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy and radiation
Placebo in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: - cisplatin/etoposide - carboplatin/paclitaxel - pemetrexed/cisplatin - pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive placebo as consolidation treatment.

Other: Placebo
Placebo IV (intravenous infusion)

Drug: Cisplatin/ Etoposide
Cisplatin/ Etoposide, as per standard of care

Drug: Carboplatin/ Paclitaxel
Carboplatin /Paclitaxel, as per standard of care

Drug: Pemetrexed/ Cisplatin
Pemetrexed / Cisplatin, as per standard of care

Drug: Pemetrexed/ Carboplatin
Pemetrexed / Carboplatin , as per standard of care

Radiation: Radiation
5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This Phase III double-blind, placebo-controlled study was conducted in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) at 87 study centers in North and South America, Europe, and Asia Pacific. The results are reported for analysis with assessment until data cut-off (DCO) date of 07 September 2023.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had a screening period (up to 28 days), followed by a treatment and follow-up period (up to 1960 days). A total of 328 participants were randomized in a 2:1 ratio to receive durvalumab + standard of care (SoC) concurrent chemoradiotherapy (cCRT) group or placebo + SoC cCRT group.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 milligram (mg) intravenous (IV) infusion every 4 weeks (Q4W) until progressive disease (PD) or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/square meter (m^2) on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin area under the plasma drug concentration-time curve (AUC) 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 every 3 weeks (Q3W) given either as 1 induction cycle prior to initiation of radiation therapy (RT) or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT) was delivered using external beam radiation therapy (EBRT) of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 milligram (mg) intravenous (IV) infusion every 4 weeks (Q4W) until progressive disease (PD) or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/square meter (m^2) on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin area under the plasma drug concentration-time curve (AUC) 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 every 3 weeks (Q3W) given either as 1 induction cycle prior to initiation of radiation therapy (RT) or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT) was delivered using external beam radiation therapy (EBRT) of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Participant Flow: Overall Study

	Durvalumab + SoC CRT	Placebo + SoC CRT
STARTED	219	109
Received treatment	218	109
COMPLETED	0	0
NOT COMPLETED	219	109
Death	142	69
Lost to Follow-up	0	1
Ongoing treatment and in follow-up at data cut off	73	37
Withdrawal by Subject	3	2
Unspecified	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The Full analysis set (FAS) included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Baseline Measures

	Durvalumab + SoC CRT	Placebo + SoC CRT	Total
Number of Participants [units: Participants]	219	109	328
Age Continuous [units: years] Mean ± Standard Deviation	62.8 ± 8.96	62.4 ± 9.50	62.6 ± 9.13
Sex: Female, Male [units: participants]
Female	53	29	82
Male	166	80	246
Race/Ethnicity, Customized [units: participants]
White	141	62	203
Black or African American	2	0	2
Asian	65	39	104
American Indian or Alaska Native	7	7	14
Other	4	1	5
Race/Ethnicity, Customized [units: participants]
Hispanic or Latino	33	21	54
Not Hispanic or Latino	186	88	274

Outcome Measures

1. Primary Outcome Measure: Progression-Free Survival (PFS) [ Time Frame: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). ]

Measure Type	Primary
Measure Name	Progression-Free Survival (PFS)
Measure Description	The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time Frame	Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Progression-Free Survival (PFS) [units: months] Median (95% Confidence Interval)	13.8 (9.5 to 16.9)	9.4 (7.5 to 16.6)

Statistical Analysis 1 for Progression-Free Survival (PFS)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.247
Hazard Ratio (HR)^[5]	0.85
95% Confidence Interval	( 0.647 to 1.123 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The hazard ratio (HR) and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for age [< 65 versus (vs.) >= 65 years] and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	The analysis was performed using the stratified log-rank test, adjusting for age (< 65 vs. >= 65 years) and stage (IIIA vs. IIIB/C).
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: Objective Response Rate (ORR) [ Time Frame: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). ]

Measure Type	Secondary
Measure Name	Objective Response Rate (ORR)
Measure Description	The ORR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of complete response (CR) or partial response (PR) based on all participants in the FAS. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions.
Time Frame	Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Objective Response Rate (ORR) [units: percentage of participants] Number (95% Confidence Interval)	60.7 (53.9 to 67.2)	60.6 (50.7 to 69.8)

Statistical Analysis 1 for Objective Response Rate (ORR)

Groups^[1]	All groups
Method^[3]	Cochran-Mantel-Haenszel
P-Value^[4]	0.976
Other^[5]	0.2
99.50% Confidence Interval	( -15.2 to 16.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	The analysis was performed using a Cochran-Mantel-Haenszel (CMH) test, stratified by age (< 65 vs. >= 65 years) and stage (IIIA vs. IIIB/C).
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	The CIs for difference in percentages were estimated using Miettinen and Nurminen’s method.

3. Secondary Outcome Measure: Overall Survival (OS) [ Time Frame: From screening until confirmed PD, assessed up to the DCO date (a maximum of approximately 1988 days). ]

Measure Type	Secondary
Measure Name	Overall Survival (OS)
Measure Description	The OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy. Median OS was calculated using the Kaplan-Meier technique.
Time Frame	From screening until confirmed PD, assessed up to the DCO date (a maximum of approximately 1988 days).
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Overall Survival (OS) [units: months] Median (95% Confidence Interval)	36.4 (26.2 to 45.6)	29.5 (23.2 to 45.1)

Statistical Analysis 1 for Overall Survival (OS)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.823
Hazard Ratio (HR)^[5]	1.03
95% Confidence Interval	( 0.778 to 1.386 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	The analysis was performed using the stratified log-rank test, adjusting for age (< 65 vs. >= 65 years) and stage (IIIA vs. IIIB/C).
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Secondary Outcome Measure: Percentage of Participants Alive at 24 Months From Randomization (OS24) [ Time Frame: Month 24 ]

Measure Type	Secondary
Measure Name	Percentage of Participants Alive at 24 Months From Randomization (OS24)
Measure Description	The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months. Median OS24 was calculated using the Kaplan-Meier technique.
Time Frame	Month 24
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Percentage of Participants Alive at 24 Months From Randomization (OS24) [units: percentage of participants] Number (95% Confidence Interval)	58.4 (51.6 to 64.7)	59.5 (49.6 to 68.2)

Statistical Analysis 1 for Percentage of Participants Alive at 24 Months From Randomization (OS24)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.847
Hazard Ratio (HR)^[5]	1.04
95% Confidence Interval	( 0.716 to 1.502 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	The analysis was performed using the stratified log-rank test, adjusting for age (< 65 vs. >= 65 years) and stage (IIIA vs. IIIB/C).
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Complete Response Rate (CRR) [ Time Frame: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). ]

Measure Type	Secondary
Measure Name	Complete Response Rate (CRR)
Measure Description	The CRR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of CR. The CR was defined as disappearance of all target lesions since baseline.
Time Frame	Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Complete Response Rate (CRR) [units: percentage of participants] Number (95% Confidence Interval)	1.8 (0.5 to 4.6)	1.8 (0.2 to 6.5)

Statistical Analysis 1 for Complete Response Rate (CRR)

Groups^[1]	All groups
Other^[5]	0.0
95% Confidence Interval	( -4.8 to 3.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	The CIs for difference in percentages was calculated using Miettinen and Nurminen's method.

6. Secondary Outcome Measure: Duration of Response (DoR) [ Time Frame: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). ]

Measure Type	Secondary
Measure Name	Duration of Response (DoR)
Measure Description	The DoR per RECIST 1.1 using BICR was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of PD. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions. The DoR was calculated using the Kaplan-Meier technique.
Time Frame	Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants. Only participants with objective response are analyzed.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	133	66
Duration of Response (DoR) [units: months] Median (Inter-Quartile Range)	30.7 (8.8 to NA) ^[1]	18.6 (7.4 to 56.5)

No statistical analysis provided for Duration of Response (DoR)

7. Secondary Outcome Measure: Disease Control Rate (DCR) [ Time Frame: Week 24 ]

Measure Type	Secondary
Measure Name	Disease Control Rate (DCR)
Measure Description	The DCR at 24 weeks per RECIST 1.1 using BICR was defined as the percentage of participants who had a best objective response of CR or PR in the first 25 weeks (to allow for late assessment within the assessment window) or who had stable disease for >= 23 weeks after randomization (to allow for an early assessment within the ± 1 week assessment window).
Time Frame	Week 24
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Disease Control Rate (DCR) [units: percentage of participants]	65.8	65.1

No statistical analysis provided for Disease Control Rate (DCR)

8. Secondary Outcome Measure: Time to Death or Distant Metastasis (TTDM) [ Time Frame: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). ]

Measure Type	Secondary
Measure Name	Time to Death or Distant Metastasis (TTDM)
Measure Description	The TTDM per RECIST 1.1 using BICR was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside the radiation field according to RECIST 1.1 or proven by biopsy.
Time Frame	Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

	Description
Durvalumab + SoC CRT	Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).
Placebo + SoC CRT	Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Time to Death or Distant Metastasis (TTDM) [units: months] Median (95% Confidence Interval)	51.0 (25.0 to NA) ^[1]	46.3 (16.6 to NA) ^[1]

Statistical Analysis 1 for Time to Death or Distant Metastasis (TTDM)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.790
Hazard Ratio (HR)^[5]	0.95
95% Confidence Interval	( 0.649 to 1.413 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	The analysis was performed using the stratified log-rank test, adjusting for age (< 65 vs. >= 65 years) and stage (IIIA vs. IIIB/C).
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

9. Secondary Outcome Measure: Time from Randomization to Second Progression (PFS2) [ Time Frame: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). ]

Measure Type	Secondary
Measure Name	Time from Randomization to Second Progression (PFS2)
Measure Description	The PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS per Investigator assessment) or death. The date of the second progression was recorded by the Investigator and defined according to local standard clinical practice and could have involved any of objective radiological, symptomatic progression, or death. Median PFS2 was calculated using the Kaplan-Meier technique.
Time Frame	Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants.

Reporting Groups

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	109
Time from Randomization to Second Progression (PFS2) [units: months] Median (95% Confidence Interval)	27.8 (21.8 to 35.8)	22.0 (16.2 to 28.0)

Statistical Analysis 1 for Time from Randomization to Second Progression (PFS2)

Groups^[1]	All groups
Method^[3]	Log Rank
P-Value^[4]	0.132
Hazard Ratio (HR)^[5]	0.81
95% Confidence Interval	( 0.614 to 1.071 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	The analysis was performed using the stratified log-rank test, adjusting for age (< 65 vs. >= 65 years) and stage (IIIA vs. IIIB/C).
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

10. Secondary Outcome Measure: Serum Concentration of Durvalumab [ Time Frame: End of infusion on Week 0, pre-infusion on Weeks 4 and 12, and Month 3 follow-up ]

Measure Type	Secondary
Measure Name	Serum Concentration of Durvalumab
Measure Description	Blood samples were collected to determine the concentration of durvalumab.
Time Frame	End of infusion on Week 0, pre-infusion on Weeks 4 and 12, and Month 3 follow-up
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of durvalumab or matching placebo per protocol, for whom any post-dose data were available and did not violate or deviate from the protocol in ways that would significantly affect the PK analyses. Only participants analyzed at specific timepoint are reported.

Reporting Groups

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Measured Values

	Durvalumab + SoC CRT
Number of Participants Analyzed [units:participants]	190
Serum Concentration of Durvalumab [units: microgram per milliliter] Geometric Mean (Geometric Coefficient of Variation)
Week 0: End of infusion	452.21 (78.94%)
Week 4: Pre-infusion	82.02 (80.85%)
Week 12: Pre-infusion	123.39 (163.20%)
Month 3 Follow-up	15.79 (243.41%)

No statistical analysis provided for Serum Concentration of Durvalumab

11. Secondary Outcome Measure: Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab [ Time Frame: Pre-dose on Day 1 of Cycles 1, 2 and 4 ]

Measure Type	Secondary
Measure Name	Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
Measure Description	Blood samples were collected to determine the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence was defined as the number of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as either treatment-induced (post-baseline ADA positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to >= 4-fold during the study period). Treatment-induced ADA was defined as ADA positive only post-baseline and not detected at baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive assessments with at least 16 weeks between the first and last positive assessment, or ADA positive at the last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment without fulfilling the conditions for persistently positive.
Time Frame	Pre-dose on Day 1 of Cycles 1, 2 and 4
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ADA analysis set included all participants who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.

Reporting Groups

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Measured Values

	Durvalumab + SoC CRT
Number of Participants Analyzed [units:participants]	199
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab [units: participants]
ADA positive at any visit (ADA prevalence)	20
Treatment-emergent ADA positive (ADA incidence)	8
ADA positive at both baseline and post-baseline	2
Treatment-induced ADA	8
ADA positive at baseline only	10
Treatment-boosted ADA	0
Persistent positive	6
Transient positive	4
nAb positive at any visit	1

No statistical analysis provided for Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab

12. Secondary Outcome Measure: Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months [ Time Frame: At screening, 2, 4, 6, 8, 12, 16, and 20 weeks after randomization, then every 8 weeks ±1 week up to 52 weeks, and then every 12 weeks ±1 week thereafter until PFS2. Assessed up to 12 months. ]

Measure Type	Secondary
Measure Name	Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months
Measure Description	Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a total score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status scale with higher scores on the global health status/quality of life (QoL) and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as a change from baseline of >=10.
Time Frame	At screening, 2, 4, 6, 8, 12, 16, and 20 weeks after randomization, then every 8 weeks ±1 week up to 52 weeks, and then every 12 weeks ±1 week thereafter until PFS2. Assessed up to 12 months.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS included all randomized participants. Only participants analyzed at baseline through Month 12 are reported.

Reporting Groups

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	196	95
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months [units: units on a scale] Mean (95% Confidence Interval)
EORTC QLQ-C30: Global health status/QoL	-0.5 (-2.3 to 1.4)	0.2 (-2.4 to 2.8)
EORTC QLQ-C30: Physical functioning	-1.4 (-3.0 to 0.2)	-0.8 (-3.1 to 1.4)
EORTC QLQ-C30: Fatigue symptoms	1.3 (-0.9 to 3.4)	0.3 (-2.8 to 3.3)
EORTC QLQ-C30: Appetite loss symptoms	3.0 (0.9 to 5.2)	0.3 (-2.7 to 3.3)
EORTC QLQ-LC13: Dyspnoea symptoms	1.1 (-1.0 to 3.1)	-1.3 (-4.2 to 1.6)
EORTC QLQ-LC13: Cough symptoms	-6.1 (-8.6 to -3.6)	-6.5 (-10.0 to -2.9)
EORTC QLQ-LC13: Pain in chest symptoms	-1.9 (-4.2 to 0.4)	-0.8 (-3.9 to 2.4)

No statistical analysis provided for Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months

13. Secondary Outcome Measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days. ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measure Description	An AE is the development of any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A SAE is an AE occurring during any study phase, that fulfils 1 or more of the following criteria: death, life-threatening, in-participant hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, and an important medical event that may jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AEs leading to discontinuation of study treatment were those with action taken was 'Drug Permanently Discontinued' for any study treatment.
Time Frame	From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days.
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety analysis set included all participants who received at least 1 dose of randomized treatment.

Reporting Groups

Description

Durvalumab + SoC CRT

Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met.

Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.

1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle.
2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT.
3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle.
4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Placebo + SoC CRT

Measured Values

	Durvalumab + SoC CRT	Placebo + SoC CRT
Number of Participants Analyzed [units:participants]	219	108
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [units: percentage of participants]
Any AE	98.6	100.0
Any SAE	47.0	51.9
Any AE leading to discontinuation of treatment	34.7	19.4
Any immune-mediated AE	48.9	28.7

No statistical analysis provided for Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Serious Adverse Events

Time Frame	From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days.
Additional Description	The Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality was determined for participants in FAS.

Reporting Groups

Description

Durvalumab + SoC CRT

Placebo + SoC CRT

Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Serious Adverse Events

Durvalumab + SoC CRT

Placebo + SoC CRT

Total, serious adverse events

# participants affected / at risk

103/219 (47.03%)

56/108 (51.85%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Gastrointestinal disorders

Oesophageal stenosis¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Gastrointestinal disorders

Oesophageal ulcer¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Gastrointestinal disorders

Oesophagitis¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Gastrointestinal disorders

Pancreatitis acute¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Gastrointestinal disorders

Upper gastrointestinal haemorrhage¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Blood and lymphatic system disorders

Mesenteric lymphadenitis¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

General disorders and administration site conditions

Condition aggravated¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

General disorders and administration site conditions

Death¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

2/219 (0.91%)

5/108 (4.63%)

# events

General disorders and administration site conditions

Mucosal inflammation¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

2/219 (0.91%)

0/108 (0.00%)

# events

Blood and lymphatic system disorders

Neutropenia¹,^†

# participants affected / at risk

3/219 (1.37%)

0/108 (0.00%)

# events

Hepatobiliary disorders

Cholelithiasis¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Immune system disorders

Drug hypersensitivity¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

Acute hepatitis C¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Blood and lymphatic system disorders

Pancytopenia¹,^†

# participants affected / at risk

2/219 (0.91%)

1/108 (0.93%)

# events

Infections and infestations

Brain abscess¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

COVID-19¹,^†

# participants affected / at risk

3/219 (1.37%)

0/108 (0.00%)

# events

Infections and infestations

COVID-19 pneumonia¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Infections and infestations

Diverticulitis¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Infections and infestations

Herpes zoster¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

Infectious pleural effusion¹,^†

# participants affected / at risk

2/219 (0.91%)

0/108 (0.00%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

Lower respiratory tract infection¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

Mastoiditis¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Cardiac disorders

Acute coronary syndrome¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Cardiac disorders

Acute myocardial infarction¹,^†

# participants affected / at risk

3/219 (1.37%)

0/108 (0.00%)

# events

Infections and infestations

Pneumocystis jirovecii pneumonia¹,^†

# participants affected / at risk

2/219 (0.91%)

0/108 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

29/219 (13.24%)

11/108 (10.19%)

# events

Infections and infestations

Pneumonia bacterial¹,^†

# participants affected / at risk

1/219 (0.46%)

4/108 (3.70%)

# events

Infections and infestations

Postoperative wound infection¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Infections and infestations

Pyelonephritis acute¹,^†

# participants affected / at risk

0/219 (0.00%)

2/108 (1.85%)

# events

Infections and infestations

Respiratory tract infection¹,^†

# participants affected / at risk

2/219 (0.91%)

0/108 (0.00%)

# events

Cardiac disorders

Angina pectoris¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

Sepsis¹,^†

# participants affected / at risk

6/219 (2.74%)

1/108 (0.93%)

# events

Infections and infestations

Septic coagulopathy¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Infections and infestations

Septic shock¹,^†

# participants affected / at risk

2/219 (0.91%)

0/108 (0.00%)

# events

Infections and infestations

Soft tissue infection¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/219 (0.46%)

2/108 (1.85%)

# events

Infections and infestations

Viral infection¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

0/219 (0.00%)

2/108 (1.85%)

# events

Injury, poisoning and procedural complications

Extradural haematoma¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Injury, poisoning and procedural complications

Fall¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Injury, poisoning and procedural complications

Femur fracture¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Injury, poisoning and procedural complications

Radiation oesophagitis¹,^†

# participants affected / at risk

5/219 (2.28%)

5/108 (4.63%)

# events

Injury, poisoning and procedural complications

Radiation pneumonitis¹,^†

# participants affected / at risk

4/219 (1.83%)

4/108 (3.70%)

# events

Injury, poisoning and procedural complications

Road traffic accident¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Cardiac disorders

Cardiac arrest¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Investigations

Blood creatinine increased¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Cardiac disorders

Cardiac failure¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Investigations

Hepatic enzyme increased¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Cardiac disorders

Cardiac failure acute¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Investigations

Platelet count decreased¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

4/219 (1.83%)

2/108 (1.85%)

# events

Metabolism and nutrition disorders

Type 1 diabetes mellitus¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Metabolism and nutrition disorders

Type 2 diabetes mellitus¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Cardiac disorders

Myocarditis¹,^†

# participants affected / at risk

2/219 (0.91%)

0/108 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Musculoskeletal and connective tissue disorders

Spinal stenosis¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Musculoskeletal and connective tissue disorders

Spondylolisthesis¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal carcinoma¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of skin¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Nervous system disorders

Amyotrophic lateral sclerosis¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Nervous system disorders

Basal ganglia haemorrhage¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Nervous system disorders

Carotid artery thrombosis¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Nervous system disorders

Cerebrovascular accident¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Cardiac disorders

Supraventricular tachycardia¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Nervous system disorders

Sciatica¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Cardiac disorders

Tachycardia¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Psychiatric disorders

Psychotic disorder¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Reproductive system and breast disorders

Benign prostatic hyperplasia¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Atelectasis¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

1/219 (0.46%)

2/108 (1.85%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

2/219 (0.91%)

2/108 (1.85%)

# events

Respiratory, thoracic and mediastinal disorders

Emphysema¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

4/219 (1.83%)

0/108 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Haemothorax¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease¹,^†

# participants affected / at risk

3/219 (1.37%)

0/108 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Organising pneumonia¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Respiratory, thoracic and mediastinal disorders

Pleural effusion¹,^†

# participants affected / at risk

2/219 (0.91%)

0/108 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumonitis¹,^†

# participants affected / at risk

13/219 (5.94%)

5/108 (4.63%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumothorax¹,^†

# participants affected / at risk

3/219 (1.37%)

1/108 (0.93%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumothorax spontaneous¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

3/219 (1.37%)

3/108 (2.78%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary haemorrhage¹,^†

# participants affected / at risk

3/219 (1.37%)

1/108 (0.93%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory failure¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Blood and lymphatic system disorders

Febrile neutropenia¹,^†

# participants affected / at risk

6/219 (2.74%)

6/108 (5.56%)

# events

Endocrine disorders

Hypothyroidism¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Skin and subcutaneous tissue disorders

Toxic epidermal necrolysis¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Vascular disorders

Aortic aneurysm¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Eye disorders

Cataract¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Vascular disorders

Peripheral ischaemia¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Vascular disorders

Thrombophlebitis¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Blood and lymphatic system disorders

Hypereosinophilic syndrome¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

Gastrointestinal disorders

Colitis¹,^†

# participants affected / at risk

1/219 (0.46%)

1/108 (0.93%)

# events

Gastrointestinal disorders

Gastric ulcer¹,^†

# participants affected / at risk

0/219 (0.00%)

1/108 (0.93%)

# events

Blood and lymphatic system disorders

Leukopenia¹,^†

# participants affected / at risk

1/219 (0.46%)

0/108 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 26.0

Other Adverse Events

Time Frame	From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days.
Additional Description	The Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality was determined for participants in FAS.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

Description

Durvalumab + SoC CRT

Placebo + SoC CRT

Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m^2 on Days 1 and 8 and etoposide 50 mg/m^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days).

Other Adverse Events

Durvalumab + SoC CRT

Placebo + SoC CRT

Total, other (not including serious) adverse events

# participants affected / at risk

209/219 (95.43%)

106/108 (98.15%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

55/219 (25.11%)

26/108 (24.07%)

# events

Gastrointestinal disorders

Odynophagia¹,^†

# participants affected / at risk

14/219 (6.39%)

6/108 (5.56%)

# events

Gastrointestinal disorders

Oesophagitis¹,^†

# participants affected / at risk

20/219 (9.13%)

8/108 (7.41%)

# events

Blood and lymphatic system disorders

Lymphopenia¹,^†

# participants affected / at risk

29/219 (13.24%)

18/108 (16.67%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

28/219 (12.79%)

7/108 (6.48%)

# events

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

30/219 (13.70%)

8/108 (7.41%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

36/219 (16.44%)

12/108 (11.11%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

29/219 (13.24%)

3/108 (2.78%)

# events

Blood and lymphatic system disorders

Neutropenia¹,^†

# participants affected / at risk

59/219 (26.94%)

28/108 (25.93%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

10/219 (4.57%)

7/108 (6.48%)

# events

Infections and infestations

COVID-19¹,^†

# participants affected / at risk

13/219 (5.94%)

7/108 (6.48%)

# events

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

44/219 (20.09%)

19/108 (17.59%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

13/219 (5.94%)

3/108 (2.78%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

21/219 (9.59%)

15/108 (13.89%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

13/219 (5.94%)

8/108 (7.41%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

16/219 (7.31%)

5/108 (4.63%)

# events

Injury, poisoning and procedural complications

Radiation oesophagitis¹,^†

# participants affected / at risk

38/219 (17.35%)

18/108 (16.67%)

# events

Injury, poisoning and procedural complications

Radiation pneumonitis¹,^†

# participants affected / at risk

33/219 (15.07%)

17/108 (15.74%)

# events

Injury, poisoning and procedural complications

Radiation skin injury¹,^†

# participants affected / at risk

26/219 (11.87%)

11/108 (10.19%)

# events

Investigations

Amylase increased¹,^†

# participants affected / at risk

18/219 (8.22%)

11/108 (10.19%)

# events

Investigations

Blood creatinine increased¹,^†

# participants affected / at risk

10/219 (4.57%)

7/108 (6.48%)

# events

Investigations

Lymphocyte count decreased¹,^†

# participants affected / at risk

10/219 (4.57%)

6/108 (5.56%)

# events

Investigations

Neutrophil count decreased¹,^†

# participants affected / at risk

24/219 (10.96%)

8/108 (7.41%)

# events

Investigations

Platelet count decreased¹,^†

# participants affected / at risk

17/219 (7.76%)

11/108 (10.19%)

# events

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

90/219 (41.10%)

40/108 (37.04%)

# events

105

Investigations

Weight decreased¹,^†

# participants affected / at risk

24/219 (10.96%)

13/108 (12.04%)

# events

Investigations

White blood cell count decreased¹,^†

# participants affected / at risk

18/219 (8.22%)

11/108 (10.19%)

# events

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

46/219 (21.00%)

21/108 (19.44%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

25/219 (11.42%)

10/108 (9.26%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

20/219 (9.13%)

14/108 (12.96%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

13/219 (5.94%)

12/108 (11.11%)

# events

Musculoskeletal and connective tissue disorders

Myalgia¹,^†

# participants affected / at risk

14/219 (6.39%)

5/108 (4.63%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

11/219 (5.02%)

5/108 (4.63%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

18/219 (8.22%)

5/108 (4.63%)

# events

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

26/219 (11.87%)

10/108 (9.26%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

46/219 (21.00%)

18/108 (16.67%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

20/219 (9.13%)

8/108 (7.41%)

# events

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

11/219 (5.02%)

8/108 (7.41%)

# events

Respiratory, thoracic and mediastinal disorders

Hiccups¹,^†

# participants affected / at risk

11/219 (5.02%)

4/108 (3.70%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumonitis¹,^†

# participants affected / at risk

12/219 (5.48%)

4/108 (3.70%)

# events

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

10/219 (4.57%)

7/108 (6.48%)

# events

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

16/219 (7.31%)

13/108 (12.04%)

# events

Endocrine disorders

Hyperthyroidism¹,^†

# participants affected / at risk

27/219 (12.33%)

5/108 (4.63%)

# events

Endocrine disorders

Hypothyroidism¹,^†

# participants affected / at risk

36/219 (16.44%)

9/108 (8.33%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

22/219 (10.05%)

3/108 (2.78%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

18/219 (8.22%)

9/108 (8.33%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

18/219 (8.22%)

13/108 (12.04%)

# events

Gastrointestinal disorders

Abdominal pain upper¹,^†

# participants affected / at risk

13/219 (5.94%)

5/108 (4.63%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

35/219 (15.98%)

31/108 (28.70%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

30/219 (13.70%)

10/108 (9.26%)

# events

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

12/219 (5.48%)

12/108 (11.11%)

# events

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

29/219 (13.24%)

9/108 (8.33%)

# events

Blood and lymphatic system disorders

Leukopenia¹,^†

# participants affected / at risk

48/219 (21.92%)

19/108 (17.59%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 26.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Download
SAP
Download
CSP
Download
CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Study

1-877-400-4656

AstraZeneca@emergingmed.com

Investigators

Principal Investigator

Jeffrey Bradley

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

SAP

CSP

CSR Synopsis

Trial Results Summaries