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TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expre

3 months ago
  • #non-small cell lung cancer
  • #immunotherapy
  • #clinical trial
  • TROPION-Lung10 is a phase 3 study evaluating datopotamab deruxtecan (Dato-DXd) plus rilvegostomig versus pembrolizumab in treatment-naïve nonsquamous NSCLC patients with high PD-L1 expression (≥50%) and no actionable genomic alterations.
  • The study aims to address primary or acquired resistance to PD-(L)1 inhibitors by combining a TROP2-directed antibody-drug conjugate (Dato-DXd) and a bispecific anti-PD-1/anti-TIGIT antibody (rilvegostomig).
  • Approximately 675 patients will be randomized (2:1:2) to receive Dato-DXd + rilvegostomig, rilvegostomig alone, or pembrolizumab, with dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in the TROP2 biomarker-positive population.
  • Secondary endpoints include objective response rate, duration of response, PFS2, patient-reported outcomes, and safety assessments.
  • The study is sponsored by AstraZeneca, with Daiichi Sankyo collaborating on datopotamab deruxtecan development.