Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary

The purpose of this study was to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared to docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody treatment, with the anti-PD-(L)1 antibody administered either in combination with or sequentially before or after the platinum-based chemotherapy.

Timeline

Start

2021-07-27

Primary completion

2023-12-20

Completion

2023-12-20

Publications

• Background Zhou Q, Zhao J, Gao B, et al. SAFFRON-301: A Phase 3 Study of Tislelizumab With Sitravatinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy and an Anti-PD-1/PD-L1 Antibody. Poster presented at: ESMO Congress 2022; September, 2022; Paris, France.
• Results Zhou Q, Gao B, et al. SAFFRON-301: Sitravatinib PLUS Tislelizumab in Advanced/Metastatic NSCLC Progressing on/after Chemotherapy and Anti-PD-(L)1.
• Zhou Q, Gao B, Hu J, Zhao J, Wang M, He K, Zhang W, Liu C, Fang J, Li XY, Wang Z, Matos M, Kwatra V, Zheng W, Wang C, Chen Y, Zhang J, Wang J, Wu YL. SAFFRON-301: a randomised phase III study of sitravatinib in combination with tislelizumab in patients with locally advanced or metastatic non-small cell lung cancer. BMJ Oncol. 2026 Feb 19;5(1):e000890. doi: 10.1136/bmjonc-2025-000890. eCollection 2026.

Drugs

Indications