Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Reason given: Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.
Key facts
- Where
- Beijing, Changchun, Changsha, Changzhou, Chengdu, Chenzhou, Chongqing, Dalian, Fuzhou, Guangzhou, Hangzhou, Harbin, Hefei, Hengyang, Jinan, Kunming, Lanzhou, Nanchang, Nanjing, Nanning, Qingdao, Shanghai, Shantou, Shenyang, Shenzhen, Suzhou, Taizhou, Tianjin, Ürümqi, Wuhan, Xiamen, Xuzhou, Yinchuan, and Zhengzhou, ChinaSee the 52 sites
- Phase
- Phase 3
Where in China
- Beijing Cancer HospitalBeijing, ChinaNo longer taking part
- Peking Union Medical College HospitalBeijing, ChinaNo longer taking part
- The First Hospital of Jilin UniversityChangchun, ChinaNo longer taking part
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNo longer taking part
- Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch ChengChangzhou, ChinaNo longer taking part
- Sichuan Cancer Hospital and InstituteChengdu, ChinaNo longer taking part
- West China Hospital，Sichuan UniversityChengdu, ChinaNo longer taking part
- The First Peoples Hospital of ChenzhouChenzhou, ChinaNo longer taking part
- Daping Hospital, Third Military Medical UniversityChongqing, ChinaNo longer taking part
- Xinqiao Hospital Affiliated to the Army Medical UniversityChongqing, ChinaNo longer taking part
- First Affiliated Hospital of Dalian Medical UniversityDalian, ChinaNo longer taking part
- Fujian Cancer HospitalFuzhou, ChinaNo longer taking part
- Fujian Provincial HospitalFuzhou, ChinaNo longer taking part
- Cancer Center of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
- Guangdong Provincial Peoples HospitalGuangzhou, ChinaNo longer taking part
- Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaNo longer taking part
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- Zhejiang Cancer HospitalHangzhou, ChinaNo longer taking part
- Harbin Medical University Cancer HospitalHarbin, ChinaNo longer taking part
- Anhui Provincial Cancer Hospital aka West Branch of Anhui Province HospitalHefei, ChinaNo longer taking part
- The Second Hospital University of South ChinaHengyang, ChinaNo longer taking part
- Jinan Central HospitalJinan, ChinaNo longer taking part
- Shandong Cancer HospitalJinan, ChinaNo longer taking part
- Yunnan Cancer HospitalKunming, ChinaNo longer taking part
- The First Hospital of Lanzhou UniversityLanzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Nanchang University Branch DonghuNanchang, ChinaNo longer taking part
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaNo longer taking part
- Nanjing First HospitalNanjing, ChinaNo longer taking part
- Zhongda Hospital Southeast UniversityNanjing, ChinaNo longer taking part
- The Peoples Hospital of Guangxi Zhuang Autonomous RegionNanning, ChinaNo longer taking part
- The Tumor Hospital Affiliated to Guangxi Medical UniversityNanning, ChinaNo longer taking part
- The Affiliated Hospital of Qingdao University Branch LaoshanQingdao, ChinaNo longer taking part
- Affiliated Zhongshan Hospital of Fudan UniversityShanghai, ChinaNo longer taking part
- Huashan Hospital Affiliated to Fudan UniversityShanghai, ChinaNo longer taking part
- Rui Jin Hospital Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part
- Cancer Hospital of Shantou University Medical CollegeShantou, ChinaNo longer taking part
- Liaoning Cancer Hospital and InstituteShenyang, ChinaNo longer taking part
- Cancer Hospital Chinse Academy of Medical Sciences, Shenzhen CenterShenzhen, ChinaNo longer taking part
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
- The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
- Taizhou Hospital of ZhejiangTaizhou, ChinaNo longer taking part
- Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaNo longer taking part
- Tianjin Medical University General HospitalTianjin, ChinaNo longer taking part
- Affiliated Cancer Hospital of Xinjiang Medical UniversityÜrümqi, ChinaNo longer taking part
- Hubei Cancer HospitalWuhan, ChinaNo longer taking part
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
- Union Hospital of Tongji Medical College Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaNo longer taking part
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaNo longer taking part
- General Hospital of Ningxia Medical UniversityYinchuan, ChinaNo longer taking part
- Henan Cancer HospitalZhengzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNo longer taking part
Trial details
- Who runs it
- BeiGene
- Trial code
- NCT04921358
- Record updated
- 29 June 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Metastatic or unresectable locally advanced histologically or cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent; Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers; No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement; Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC; No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or vascular endothelial growth factor (VEGF)- or VEGFR inhibitor); At least 1 measurable lesion as defined based on RECIST v1.1 by investigator.
Exclusion: Has received docetaxel as monotherapy or in combination with other therapies; Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding; Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis; Active autoimmune diseases or history of autoimmune diseases that may relapse; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply; Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day).