NCT06417814

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 744 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Dato-DXd	Dato-DXd will be administered as IV infusion.
DRUG	Osimertinib	Osimertinib will be administered orally.
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.

Timeline

• Start date: 2024-10-04
• Primary completion: 2026-09-30
• Completion: 2028-09-27
• First posted: 2024-05-16
• Last updated: 2026-03-02

Locations

302 sites across 27 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study