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A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced Squamous Non-small Cell Lung Cancer

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Trial Profile

A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced Squamous Non-small Cell Lung Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2025

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At a glance

  • Drugs Tislelizumab (Primary) ; Carboplatin; Paclitaxel
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIONALE 307
  • Sponsors BeiGene; BeOne Medicines

Most Recent Events

  • 20 Oct 2025 According to BeOne Medicine media release, company announced the presentation of data from two pivotal Phase 3 trials RATIONALE-307 and 312 at the European Society of Medical Oncology 2025 Congress (ESMO 2025) in Berlin, Germany, on Oct. 18, 12:00 - 12:45 PM CEST.
  • 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.
  • 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.

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