Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

Summary

This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Timeline

Start

2019-07-22

Primary completion

2023-04-19

Completion

2023-12-29

Publications

• Results Cheng Y, Fan Y, Zhao Y, Huang D, Li X, Zhang P, Kang M, Yang N, Zhong D, Wang Z, Yu Y, Zhang Y, Zhao J, Qin T, Chen C, Leaw S, Zheng W, Song Y; RATIONALE-312 Study Group. Tislelizumab Plus Platinum and Etoposide Versus Placebo Plus Platinum and Etoposide as First-Line Treatment for Extensive-Stage SCLC (RATIONALE-312): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 3 Clinical Trial. J Thorac Oncol. 2024 Jul;19(7):1073-1085. doi: 10.1016/j.jtho.2024.03.008. Epub 2024 Mar 7.
• Fan Y, Zhao Y, Huang D, Zhao J, Qin T, He W, Chen C, Sun P, Naicker K, Song Y; RATIONALE-312 Study Group. First-Line Tislelizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Extensive-Stage SCLC: A Long-Term Survival and Programmed Death-Ligand 1 Subgroup Analysis From the Randomized, Phase 3 RATIONALE-312 Trial. J Thorac Oncol. 2026 Jun;21(6):103655. doi: 10.1016/j.jtho.2026.103655. Epub 2026 Mar 6.
• Cheng Y, Qin T, Chen C, B Barnes F, Barnes G. Tislelizumab plus platinum and etoposide versus placebo plus platinum and etoposide as first-line treatment for extensive-stage small-cell lung cancer: patient-reported outcomes in the RATIONALE-312 trial. Curr Med Res Opin. 2025 Dec;41(12):2357-2367. doi: 10.1080/03007995.2026.2620691. Epub 2026 Jan 30.
• Long R, Chen F. First-line chemotherapy with tislelizumab for patients with extensive-stage small cell lung cancer: a cost-effectiveness analysis. Sci Rep. 2024 Dec 30;14(1):31958. doi: 10.1038/s41598-024-83509-x.
• Wu J, Zhang A, Li L, Liu S, Yang F, Yang R. Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined With Chemotherapy in First-line Treatment of Small Cell Lung Cancer. Clin Ther. 2021 Mar;43(3):582-593.e2. doi: 10.1016/j.clinthera.2020.12.017. Epub 2021 Jan 25.

Drugs

Indications