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: 04 Mar 2024
Price :
$35
*
At a glance
- Drugs Carboplatin (Primary) ; Paclitaxel (Primary) ; Tislelizumab (Primary)
- Indications Non-small cell lung cancer; Squamous cell cancer
- Focus Registrational; Therapeutic Use
- Acronyms RATIONALE 307
- Sponsors BeiGene
- 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).