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A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

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Trial Profile

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2025

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At a glance

  • Drugs Datopotamab deruxtecan (Primary) ; Pembrolizumab (Primary)
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TROPION-Lung08
  • Sponsors Daiichi Sankyo Company

Most Recent Events

  • 16 Apr 2024 Planned End Date changed from 1 Jun 2026 to 30 Apr 2028.
  • 16 Apr 2024 Planned primary completion date changed from 1 Jun 2026 to 29 Feb 2028.
  • 16 Aug 2023 According to a Daiichi Sankyo company media release, data from this study will be presented at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC23) being held September 9-12, 2023.

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