Study identifier:D516KC00001
ClinicalTrials.gov identifier:NCT06417814
EudraCT identifier:N/A
CTIS identifier:2024-511362-37-00
A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants with EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)
metastatic non-small cell lung cancer
Phase 3
No
Dato-DXd, Osimertinib, Pemetrexed, Carboplatin, Cisplatin
All
630
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
Daiichi Sankyo
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in participants with epidermal growth factor receptor gene mutation (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on prior osimertinib treatment. Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups: 1. Dato-DXd + osimertinib combination therapy 2. Dato-DXd monotherapy 3. Platinum-based doublet chemotherapy Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator, unacceptable toxicity, or other discontinuation criterion is met. After study intervention discontinuation, all participants will undergo an end of treatment (EoT) visit within 35 days of discontinuation and will be followed up for safety assessments 28 (+ 7) days after their last dose of study intervention.
Location
Status
Location
Liverpool, Australia, 2170
Status
Recruiting
Location
Porto Alegre, Brazil, 90610-000
Status
Not yet recruiting
Location
St Leonards, Australia, 2065
Status
Recruiting
Location
Gent, Belgium, 9000
Status
Recruiting
Location
Nedlands, Australia, 6009
Status
Recruiting
Location
Heidelberg, Australia, 3084
Status
Recruiting
Location
Ghent, Belgium, 9000
Status
Recruiting
Location
São Paulo, Brazil, 01323-900
Status
Not yet recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Group 1: Dato-DXd + Osimertinib Combination Therapy Participants will receive Dato-DXd 6 mg/kg as IV infusion Q3W on Day 1 of every 21-day cycle, and osimertinib 80 milligrams (mg) once daily (QD) orally, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met. | Drug: Dato-DXd Dato-DXd will be administered as IV infusion. Other Name: DS-1062a Drug: Osimertinib Osimertinib will be administered orally. Other Name: Tagrisso Other Name: AZD9291 |
Experimental: Group 2: Dato-DXd Monotherapy Participants will receive Dato-DXd 6 milligrams per kilogram (mg/kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21-day cycle, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met. | Drug: Dato-DXd Dato-DXd will be administered as IV infusion. Other Name: DS-1062a |
Experimental: Group 3: Platinum-based Doublet Chemotherapy Participants will receive pemetrexed 500 milligrams per meter square (mg/m2) in combination with carboplatin (AUC5) or cisplatin 75 mg/m2 as IV infusion Q3W for 4 cycles followed by pemetrexed maintenance 500 mg/m2 as IV infusion Q3W, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or another discontinuation criterion is met. | Drug: Pemetrexed Pemetrexed will be administered as IV infusion. Drug: Carboplatin Carboplatin will be administered as IV infusion. Drug: Cisplatin Cisplatin will be administered as IV infusion. |
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