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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2026

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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; Daiichi Sankyo Inc

Most Recent Events

  • 19 Aug 2026 Timeframe for primary endpoint 'PFS' changed from 44 months to 46 months and for 'OS' its changed from 71 months to 72 months.
  • 12 Jun 2026 Planned End Date changed from 30 Apr 2028 to 4 Mar 2032.
  • 12 Jun 2026 Planned primary completion date changed from 29 Feb 2028 to 4 Mar 2030.

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