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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

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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: 18 Apr 2025

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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

  • 15 Apr 2025 Planned End Date changed from 1 Nov 2025 to 31 Oct 2025.
  • 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.

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