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 - TROPION-Lung15

Study identifier:D516KC00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

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)

Medical condition

metastatic non-small cell lung cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Dato-DXd, Osimertinib, Pemetrexed, Carboplatin, Cisplatin

Sex

All

Estimated Enrollment

630

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 12 Aug 2024
Estimated Primary Completion Date: 08 Sept 2026
Estimated Study Completion Date: 08 Feb 2028

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria