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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer

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

Latest Information Update: 30 Oct 2024

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At a glance

  • Drugs Carboplatin (Primary) ; Cisplatin (Primary) ; Paclitaxel (Primary) ; Pemetrexed (Primary) ; Tislelizumab (Primary)
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIONALE 315
  • Sponsors BeiGene
  • Most Recent Events

    • 09 Sep 2024 According to Beigene media release, the company will share the data from the study at at the European Society of Medical Oncology 2024 Congress (ESMO 2024) in Barcelona, Spain, September 13-17, 2024. The abstract has been selected for the presentation.
    • 26 Feb 2024 According to Beigene media release, company received NMPA acceptance of a sBLA submission for treatment plus platinum-based chemotherapy followed by adjuvant treatment of adult patients with resectable Stage II or IIIA NSCLC.
    • 09 Nov 2023 According to Beigene media release, the company will submit an sBLA with the China NMPA for neoadjuvant treatment plus platinum-based chemotherapy followed by adjuvant treatment of adult patients with resectable Stage II or IIIA NSCLC in the first half of 2024.

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