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A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

Trial Profile

A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 30 Jul 2026

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At a glance

  • Drugs Belrestotug (Primary) ; Dostarlimab (Primary) ; Pembrolizumab
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; Registrational
  • Acronyms GALAXIES Lung-301
  • Sponsors GSK

Most Recent Events

  • 16 Jun 2026 Planned End Date changed from 19 Sep 2029 to 30 Aug 2027.
  • 16 Jun 2026 Planned primary completion date changed from 19 Sep 2028 to 30 Jun 2026.
  • 13 May 2025 Status changed from recruiting to discontinued ,as per iTeos Therapeutics media release.

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