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A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen

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Trial Profile

A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Sep 2024

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At a glance

  • Drugs Tislelizumab (Primary) ; Docetaxel
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIONALE 303; RATONALE
  • Sponsors BeiGene

    • Most Recent Events

    • 27 Feb 2024 According to a BeiGene media release, company to receive EMA approval for the treatment of second line metastatic NSCLC as monotherapy in the first half of 2024.
    • 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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