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A Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of CS1001 as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy

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A Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of CS1001 as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Mar 2025

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At a glance

  • Drugs Sugemalimab (Primary)
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMSTONE-301
  • Sponsors Cornerstone Pharmaceuticals Inc; CStone Pharmaceuticals

    • Most Recent Events

    • 23 Mar 2025 According to a CStone Pharmaceuticals media release, company announced submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab seeking approval for reatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) supported by data from the GEMSTONE-301 Phase III trial.
    • 14 Jun 2023 Status changed from active, no longer recruiting to completed.
    • 10 Nov 2022 According to EQRx media release, an interim analysis of OS from this pivotal Phase 3 GEMSTONE-301 trial of sugemalimab in Stage III NSCLC is expected in 2023.

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