Clinical Trial

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

Study acronym: TROPION-Lung08
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-13
notable Trial sites reduced: 243 -> 234 locations 2026-06-13
notable Primary completion pushed: 2028-02-29 -> 2030-03-04 2026-06-13
minor Completion pushed: 2028-04-30 -> 2032-03-04 2026-06-13
Trial Details
NCT Number NCT05215340
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca, Merck Sharp & Dohme LLC
Conditions Metastatic Non Small Cell Lung Cancer
Enrollment 740 participants
Start Date 2022-03-04
Primary Completion 2030-03-04 (estimated)
Study Completion 2032-03-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-12