Study identifier:D516KC00001
ClinicalTrials.gov identifier:NCT06417814
EudraCT identifier:N/A
CTIS identifier:N/A
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 Jul 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo
No locations available
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. |