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A Multi-Center, Randomized, Double-Blind, Phase III Study of Platinum-Containing Chemotherapy With or Without CS1001 in Stage IV Non-Small Cell Lung Cancer Subjects

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Trial Profile

A Multi-Center, Randomized, Double-Blind, Phase III Study of Platinum-Containing Chemotherapy With or Without CS1001 in Stage IV Non-Small Cell Lung Cancer Subjects

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2025

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At a glance

  • Drugs Sugemalimab (Primary) ; Carboplatin; Paclitaxel; Pemetrexed
  • Indications Adenocarcinoma; Non-small cell lung cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMSTONE-302
  • Sponsors CStone Pharmaceuticals

Most Recent Events

  • 24 Jul 2025 Planned End Date changed from 30 Jun 2025 to 30 Jun 2027.
  • 31 Oct 2024 According to a CStone Pharmaceuticals media release, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic tumor aberrations, based on results from this study.
  • 31 Oct 2024 According to a CStone Pharmaceuticals media release, Long-term survival data from the GEMSTONE-302 study were presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting.

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