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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)

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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 May 2025

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At a glance

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

Most Recent Events

  • 13 May 2025 Status changed from recruiting to discontinued ,as per iTeos Therapeutics media release.
  • 10 Jan 2025 According to an iTeos Therapeutics, Food and Drug Administration (FDA) and The National Medical Products Administration (NMPA) granted clearance to advance belrestotug 400mg + dostarlimab as the recommended Phase 3 dose, allowing for the activation of clinical sites in the U.S. and China, respectively.
  • 09 Jul 2024 According to an iTeos Therapeutics, Inc. media release, the company plans to present data from the most recent interim analysis of this study at a medical meeting in this year.

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