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A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer

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Trial Profile

A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2025

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At a glance

  • Drugs Tislelizumab (Primary) ; Carboplatin; Cisplatin; Pemetrexed
  • Indications Adenocarcinoma; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIONALE 304
  • Sponsors BeiGene

    • Most Recent Events

    • 27 Feb 2024 According to a BeiGene media release, company to receive EMA approval for the treatment of first line metastatic NSCLC in combination with chemotherapy.
    • 26 Feb 2024 Results published in the BeiGene Media Release
    • 26 Feb 2024 According to a BeiGene media release, based on results from three Phase 3 studies (RATIONALE-303 ,RATIONALE-304 and RATIONALE-307) the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for non-small cell lung cancer (NSCLC).

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