NCT04921358

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

A Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg intravenously once every 3 weeks
DRUG	Docetaxel	75 mg/m\^2 intravenously once every 3 weeks
DRUG	Sitravatinib	100 mg orally once daily

Timeline

• Start date: 2021-07-27
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2021-06-10
• Last updated: 2025-06-29
• Results posted: 2025-06-29

Locations

61 sites across 2 countries: Australia, China