Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

Phase 3 Active not recruiting 740 enrolled Daiichi Sankyo AstraZeneca · collab Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.

Timeline

Start: 2022-03-04
Primary completion: 2030-03-04
Completion: 2032-03-04

Publications

Levy BP, Felip E, Reck M, Yang JC, Cappuzzo F, Yoneshima Y, Zhou C, Rawat S, Xie J, Basak P, Xu L, Sands J. TROPION-Lung08: phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC. Future Oncol. 2023 Jul;19(21):1461-1472. doi: 10.2217/fon-2023-0230. Epub 2023 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Datopotamab deruxtecan	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

Summary

Timeline

Publications

Drugs

Indications