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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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Trial Profile

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: 07 Mar 2026

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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

  • 22 Feb 2026 According to a CStone Pharmaceuticals media release, the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC whose disease has not progressed following platinum-based chemoradiotherapy (CRT).
  • 16 Dec 2025 According to Ewopharma media release, in late November 2025, the European Commission (EC) granted approval for a new indication for sugemalimab as monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC). This approval, following a positive opinion from the European Medicines Agency in October.
  • 17 Oct 2025 According to a CStone Pharmaceuticals media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of sugemalimab based on the compelling results from the pivotal Phase III GEMSTONE-301 study.

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