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

Phase 3 Recruiting 744 enrolled AstraZeneca Daiichi Sankyo · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2024-10-04
Primary completion: 2026-09-30
Completion: 2028-09-27

Publications

Tan DS, Nadal E, Cheema P, Wu YL, Ahn MJ, Tanizaki J, Grainger E, Nizialek E, Forcina A, van der Gronde T, Yu HA. TROPION-Lung15: a randomized phase III study of osimertinib combined with datopotamab deruxtecan (Dato-DXd) or Dato-DXd alone versus platinum-doublet chemotherapy in patients with EGFR-mutated advanced non-small cell lung cancer and whose disease has progressed on prior osimertinib. Ther Adv Med Oncol. 2025 Dec 23;17:17588359251385410. doi: 10.1177/17588359251385410. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Datopotamab deruxtecan	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Osimertinib	Small molecule	80 mg	Oral
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications