Study of T-DXd Monotherapy in Patients with HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma who have Received 2 or More Prior Regimens - DG-06

Study identifier:D9676C00002

ClinicalTrials.gov identifier:NCT04989816

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients with HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06)

Medical condition

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Phase

Phase 2

Healthy volunteers

Study drug

Trastuzumab Deruxtecan

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 20 Aug 2021

Primary Completion Date: 16 Jun 2023

Study Completion Date: 28 Feb 2024

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2024 by AstraZeneca

Collaborators

Daiichi Sankyo Co., Ltd.

Inclusion and exclusion criteria

Location

Research Site

Wuhan, China, 430000

Location

Research Site

guangzhou, China, 510062

Location

Research Site

Shanghai, China, 200032

Location

Research Site

Hangzhou, China, 310003

Location

Research Site

nanchang, China, 330029

Location

Research Site

shenyang, China, 110001

Location

Research Site

Hefei, China, 230001

Location

Research Site

Hefei, China, 230031

Arms	Assigned Interventions
Experimental: T-DXd arm T-DXd monotherapy	-

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Participant Flow: Overall Study

	T-DXd arm
STARTED	95
Received treatment	95
COMPLETED	15
NOT COMPLETED	80
Death	77
Lost to Follow-up	3

Baseline Characteristics

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

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Baseline Measures

	T-DXd arm
Number of Participants [units: Participants]	95
Age Continuous [units: Years] Median ( Full Range )	60 (28 to 77)
Sex: Female, Male [units: ]
Female	22
Male	73
Ethnicity (NIH/OMB) [units: ]
Hispanic or Latino	0
Not Hispanic or Latino	95
Unknown or Not Reported	0
Race (NIH/OMB) [units: ]
American Indian or Alaska Native	0
Asian	95
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	0
More than one race	0
Unknown or Not Reported	0

Outcome Measures

1. Primary Outcome Measure: Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months ]

Measure Type	Primary
Measure Name	Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)
Measure Description	Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR) [units: Percentage of Participants] Number (95% Confidence Interval)	28.8 (18.8 to 40.6)

No statistical analysis provided for Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)

2. Primary Outcome Measure: Best objective response rate by RECIST 1.1 based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months ]

Measure Type	Primary
Measure Name	Best objective response rate by RECIST 1.1 based on independent central review (ICR)
Measure Description	The best response based on the overall visit responses from each RECIST 1.1 assessment or the last evaluable assessment in the absence of RECIST 1.1 progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Best objective response rate by RECIST 1.1 based on independent central review (ICR) [units: Participants]
Complete response (confirmed after at least 4 weeks)	1
Partial response (confirmed after at least 4 weeks)	20
Stable disease	37
Progression	14
Not evaluable	1

No statistical analysis provided for Best objective response rate by RECIST 1.1 based on independent central review (ICR)

3. Secondary Outcome Measure: Progression-free survival (PFS) based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) based on independent central review (ICR) [units: Months] Median (95% Confidence Interval)	5.7 (4.0 to 6.8)

No statistical analysis provided for Progression-free survival (PFS) based on independent central review (ICR)

4. Secondary Outcome Measure: Progression-free survival (PFS) rate at 3 months based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 3 months using the Kaplan-Meier technique ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) rate at 3 months based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 3 months using the Kaplan-Meier technique
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) rate at 3 months based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	69.0 (56.8 to 78.4)

No statistical analysis provided for Progression-free survival (PFS) rate at 3 months based on independent central review (ICR)

5. Secondary Outcome Measure: Progression-free survival (PFS) rate at 6 months based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 6 months using the Kaplan-Meier technique ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) rate at 6 months based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 6 months using the Kaplan-Meier technique
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) rate at 6 months based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	43.4 (30.8 to 55.3)

No statistical analysis provided for Progression-free survival (PFS) rate at 6 months based on independent central review (ICR)

6. Secondary Outcome Measure: Progression-free survival (PFS) rate at 9 months based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 9 months using the Kaplan-Meier technique ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) rate at 9 months based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 9 months using the Kaplan-Meier technique
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) rate at 9 months based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	27.1 (16.2 to 39.3)

No statistical analysis provided for Progression-free survival (PFS) rate at 9 months based on independent central review (ICR)

7. Secondary Outcome Measure: Progression-free survival (PFS) rate at 12 months based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 12 months using the Kaplan-Meier technique ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) rate at 12 months based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 12 months using the Kaplan-Meier technique
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) rate at 12 months based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	16.7 (8.0 to 28.1)

No statistical analysis provided for Progression-free survival (PFS) rate at 12 months based on independent central review (ICR)

8. Secondary Outcome Measure: Progression-free survival (PFS) rate at 15 months based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 15 months using the Kaplan-Meier technique ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) rate at 15 months based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 15 months using the Kaplan-Meier technique
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) rate at 15 months based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	11.9 (4.7 to 22.8)

No statistical analysis provided for Progression-free survival (PFS) rate at 15 months based on independent central review (ICR)

9. Secondary Outcome Measure: Progression-free survival (PFS) rate at 18 months based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 18 months using the Kaplan-Meier technique ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) rate at 18 months based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 18 months using the Kaplan-Meier technique
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) rate at 18 months based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	4.0 (0.4 to 15.6)

No statistical analysis provided for Progression-free survival (PFS) rate at 18 months based on independent central review (ICR)

10. Secondary Outcome Measure: Progression-free survival (PFS) rate at 21 months based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 21 months using the Kaplan-Meier technique ]

Measure Type	Secondary
Measure Name	Progression-free survival (PFS) rate at 21 months based on independent central review (ICR)
Measure Description	PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 21 months using the Kaplan-Meier technique
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Progression-free survival (PFS) rate at 21 months based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	4.0 (0.4 to 15.6)

No statistical analysis provided for Progression-free survival (PFS) rate at 21 months based on independent central review (ICR)

11. Secondary Outcome Measure: Disease Control Rate (DCR) based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months ]

Measure Type	Secondary
Measure Name	Disease Control Rate (DCR) based on independent central review (ICR)
Measure Description	Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD)
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Disease Control Rate (DCR) based on independent central review (ICR) [units: Percentage of participants] Number (95% Confidence Interval)	79.5 (68.4 to 88.0)

No statistical analysis provided for Disease Control Rate (DCR) based on independent central review (ICR)

12. Secondary Outcome Measure: Disease Control Rate (DCR) based on independent central review (ICR) at Week 12 [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. DCR assessed at Week 12 ]

Measure Type	Secondary
Measure Name	Disease Control Rate (DCR) based on independent central review (ICR) at Week 12
Measure Description	Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD) for at least 11 weeks (ie 12 weeks - 1 week to allow for an early assessment within the assessment window)
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. DCR assessed at Week 12
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Disease Control Rate (DCR) based on independent central review (ICR) at Week 12 [units: Percentage of participants] Number (95% Confidence Interval)	74.0 (62.4 to 83.5)

No statistical analysis provided for Disease Control Rate (DCR) based on independent central review (ICR) at Week 12

13. Secondary Outcome Measure: Duration of Response (DoR) based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months ]

Measure Type	Secondary
Measure Name	Duration of Response (DoR) based on independent central review (ICR)
Measure Description	DoR defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) or death in the absence of progression based on investigator assessments by using RECIST version 1.1
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Duration of Response (DoR) based on independent central review (ICR) [units: Months] Median (95% Confidence Interval)	6.7 (4.6 to 8.8)

No statistical analysis provided for Duration of Response (DoR) based on independent central review (ICR)

14. Secondary Outcome Measure: Overall survival (OS) based on independent central review (ICR) [ Time Frame: From date of enrolment until death due to any cause. Assessed up to approximately 30 months (from date of first subject in to data cut-off 28February2024) ]

Measure Type	Secondary
Measure Name	Overall survival (OS) based on independent central review (ICR)
Measure Description	OS based on ICR is defined as the time from date of enrolment until the date of death due to any cause
Time Frame	From date of enrolment until death due to any cause. Assessed up to approximately 30 months (from date of first subject in to data cut-off 28February2024)
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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Overall survival (OS) based on independent central review (ICR) [units: Months] Median (95% Confidence Interval)	11.1 (7.7 to 13.7)

No statistical analysis provided for Overall survival (OS) based on independent central review (ICR)

15. Secondary Outcome Measure: Best percentage change in sum of diameters of Measurable tumours based on independent central review (ICR) [ Time Frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months ]

Measure Type	Secondary
Measure Name	Best percentage change in sum of diameters of Measurable tumours based on independent central review (ICR)
Measure Description	Best percentage change based on ICR is defined as the best change in target lesion tumour size from baseline (maximum reduction or minimum increase from baseline in the absence of a reduction)
Time Frame	Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 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.
HER2-positive Full analysis set

Reporting Groups

	Description
T-DXd arm	T-DXd monotherapy

Measured Values

	T-DXd arm
Number of Participants Analyzed [units:participants]	73
Best percentage change in sum of diameters of Measurable tumours based on independent central review (ICR) [units: Percentage Change] Mean (Standard Deviation)	-22.55 (29.682)

No statistical analysis provided for Best percentage change in sum of diameters of Measurable tumours based on independent central review (ICR)

Serious Adverse Events

Time Frame	From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Additional Description	No text entered.

Reporting Groups

	Description
T-DXd	Description (Arm-group)

Serious Adverse Events

T-DXd

Total, serious adverse events

# participants affected / at risk

40/95 (42.11%)

Gastrointestinal disorders

Dysphagia¹,^†

# participants affected / at risk

1/95 (1.05%)

Gastrointestinal disorders

Upper gastrointestinal haemorrhage¹,^†

# participants affected / at risk

1/95 (1.05%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

1/95 (1.05%)

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

4/95 (4.21%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

5/95 (5.26%)

Hepatobiliary disorders

Hepatic function abnormal¹,^†

# participants affected / at risk

2/95 (2.11%)

Hepatobiliary disorders

Jaundice cholestatic¹,^†

# participants affected / at risk

1/95 (1.05%)

Infections and infestations

Covid-19 pneumonia¹,^†

# participants affected / at risk

4/95 (4.21%)

Infections and infestations

Gastrointestinal infection¹,^†

# participants affected / at risk

1/95 (1.05%)

Blood and lymphatic system disorders

Febrile neutropenia¹,^†

# participants affected / at risk

2/95 (2.11%)

Blood and lymphatic system disorders

Myelosuppression¹,^†

# participants affected / at risk

1/95 (1.05%)

Investigations

Platelet count decreased¹,^†

# participants affected / at risk

6/95 (6.32%)

Investigations

White blood cell count decreased¹,^†

# participants affected / at risk

1/95 (1.05%)

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

2/95 (2.11%)

Metabolism and nutrition disorders

Malnutrition¹,^†

# participants affected / at risk

1/95 (1.05%)

Nervous system disorders

Cerebral infarction¹,^†

# participants affected / at risk

1/95 (1.05%)

Cardiac disorders

Arrhythmia¹,^†

# participants affected / at risk

1/95 (1.05%)

Psychiatric disorders

Mental disorder¹,^†

# participants affected / at risk

1/95 (1.05%)

Gastrointestinal disorders

Abdominal distension¹,^†

# participants affected / at risk

1/95 (1.05%)

Gastrointestinal disorders

Gastrointestinal haemorrhage¹,^†

# participants affected / at risk

3/95 (3.16%)

General disorders and administration site conditions

Death¹,^†

# participants affected / at risk

2/95 (2.11%)

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

1/95 (1.05%)

Infections and infestations

Covid-19¹,^†

# participants affected / at risk

5/95 (5.26%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

5/95 (5.26%)

Infections and infestations

Sepsis¹,^†

# participants affected / at risk

1/95 (1.05%)

Investigations

Neutrophil count decreased¹,^†

# participants affected / at risk

1/95 (1.05%)

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

1/95 (1.05%)

Metabolism and nutrition disorders

Hypoalbuminaemia¹,^†

# participants affected / at risk

2/95 (2.11%)

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

2/95 (2.11%)

Nervous system disorders

Haemorrhage intracranial¹,^†

# participants affected / at risk

1/95 (1.05%)

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

1/95 (1.05%)

Renal and urinary disorders

Renal failure¹,^†

# participants affected / at risk

1/95 (1.05%)

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

1/95 (1.05%)

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

1/95 (1.05%)

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

1/95 (1.05%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 26.1

Other Adverse Events

Time Frame	From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
T-DXd	Description (Arm-group)

Other Adverse Events

T-DXd

Total, other (not including serious) adverse events

# participants affected / at risk

93/95 (97.89%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

14/95 (14.74%)

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

41/95 (43.16%)

General disorders and administration site conditions

Asthenia¹,^†

# participants affected / at risk

24/95 (25.26%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

73/95 (76.84%)

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

18/95 (18.95%)

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

7/95 (7.37%)

Hepatobiliary disorders

Hepatic function abnormal¹,^†

# participants affected / at risk

5/95 (5.26%)

Infections and infestations

Covid-19¹,^†

# participants affected / at risk

12/95 (12.63%)

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

24/95 (25.26%)

Investigations

Amylase increased¹,^†

# participants affected / at risk

5/95 (5.26%)

Investigations

Aspartate aminotransferase increased¹,^†

# participants affected / at risk

30/95 (31.58%)

Investigations

Bilirubin conjugated increased¹,^†

# participants affected / at risk

6/95 (6.32%)

Investigations

Blood alkaline phosphatase increased¹,^†

# participants affected / at risk

11/95 (11.58%)

Investigations

Blood bilirubin increased¹,^†

# participants affected / at risk

11/95 (11.58%)

Investigations

Blood creatinine increased¹,^†

# participants affected / at risk

6/95 (6.32%)

Investigations

Blood lactate dehydrogenase increased¹,^†

# participants affected / at risk

5/95 (5.26%)

Investigations

Ejection fraction decreased¹,^†

# participants affected / at risk

5/95 (5.26%)

Investigations

Gamma-glutamyltransferase increased¹,^†

# participants affected / at risk

11/95 (11.58%)

Investigations

Lymphocyte count decreased¹,^†

# participants affected / at risk

16/95 (16.84%)

Investigations

Neutrophil count decreased¹,^†

# participants affected / at risk

58/95 (61.05%)

Investigations

Platelet count decreased¹,^†

# participants affected / at risk

50/95 (52.63%)

Investigations

Weight decreased¹,^†

# participants affected / at risk

27/95 (28.42%)

Investigations

White blood cell count decreased¹,^†

# participants affected / at risk

69/95 (72.63%)

Investigations

White blood cell count increased¹,^†

# participants affected / at risk

6/95 (6.32%)

Metabolism and nutrition disorders

Decreased appetite¹,^†

# participants affected / at risk

38/95 (40.00%)

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

8/95 (8.42%)

Metabolism and nutrition disorders

Hyperuricaemia¹,^†

# participants affected / at risk

9/95 (9.47%)

Blood and lymphatic system disorders

Thrombocytopenia¹,^†

# participants affected / at risk

6/95 (6.32%)

Metabolism and nutrition disorders

Hypoalbuminaemia¹,^†

# participants affected / at risk

37/95 (38.95%)

Metabolism and nutrition disorders

Hypocalcaemia¹,^†

# participants affected / at risk

23/95 (24.21%)

Metabolism and nutrition disorders

Hypochloraemia¹,^†

# participants affected / at risk

6/95 (6.32%)

Metabolism and nutrition disorders

Hypokalaemia¹,^†

# participants affected / at risk

25/95 (26.32%)

Metabolism and nutrition disorders

Hypoproteinaemia¹,^†

# participants affected / at risk

5/95 (5.26%)

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

5/95 (5.26%)

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

9/95 (9.47%)

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

5/95 (5.26%)

Gastrointestinal disorders

Abdominal distension¹,^†

# participants affected / at risk

8/95 (8.42%)

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

6/95 (6.32%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

18/95 (18.95%)

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

6/95 (6.32%)

Gastrointestinal disorders

Mouth ulceration¹,^†

# participants affected / at risk

5/95 (5.26%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

30/95 (31.58%)

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

9/95 (9.47%)

Infections and infestations

Coronavirus infection¹,^†

# participants affected / at risk

5/95 (5.26%)

Metabolism and nutrition disorders

Hyponatraemia¹,^†

# participants affected / at risk

21/95 (22.11%)

Nervous system disorders

Hypoaesthesia¹,^†

# participants affected / at risk

6/95 (6.32%)

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

7/95 (7.37%)

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease¹,^†

# participants affected / at risk

5/95 (5.26%)

Respiratory, thoracic and mediastinal disorders

Productive cough¹,^†

# participants affected / at risk

5/95 (5.26%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 26.1

Certain Agreements

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

There is NOT 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.

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 Clinical Study Information Center
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

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

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSP redacted

SAP redacted

CSR Synopsis redacted

Trial Results Summaries