Clinical Trial

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

Study acronym: TROPION-Lung15
Recruiting Phase 3
View on ClinicalTrials.gov →
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).
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2024-05-13; most recent amendment 2026-05-13.
Status change: Active, Not Recruiting → Recruiting 2026-01-08
Status change: Recruiting → Active, Not Recruiting 2025-10-13
Status change: Not Yet Recruiting → Recruiting 2024-10-23
Trial Details
NCT Number NCT06417814
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions Metastatic Non-small Cell Lung Cancer
Enrollment 744 participants
Start Date 2024-10-04
Primary Completion 2026-09-30 (estimated)
Study Completion 2028-09-27 (estimated)
Updated on ClinicalTrials.gov 2026-05-14