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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: 17 Apr 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

  • 25 Mar 2026 According to a CStone Pharmaceuticals media release, company announced that, sugalimab has once again received a recommendation from the European Society for Medical Oncology (ESMO) guidelines. This time, sugalimab was included in the Early and Locally Advanced Non-Small-Cell Lung Cancer Living Guideline for consolidation therapy in patients with stage III non-small cell lung cancer (NSCLC) after concurrent or sequential chemoradiotherapy.
  • 23 Feb 2026 According to a CStone Pharmaceuticals media release, company will advance regulatory filings for sugemalimab in additional indications, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC).
  • 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).

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