Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Megadott ok: 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, Shenzhen, Shenyang, Suzhou, Taizhou, Tianjin, Ürümqi, Wuhan, Xiamen, Xuzhou, Yinchuan és Zhengzhou, KínaSee the 52 sites
- Phase
- 3. fázis
Where in Kína
- Beijing Cancer HospitalBeijing, KínaNo longer taking part
- Peking Union Medical College HospitalBeijing, KínaNo longer taking part
- The First Hospital of Jilin UniversityChangchun, KínaNo longer taking part
- The Second Xiangya Hospital of Central South UniversityChangsha, KínaNo longer taking part
- Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch ChengChangzhou, KínaNo longer taking part
- Sichuan Cancer Hospital and InstituteChengdu, KínaNo longer taking part
- West China Hospital，Sichuan UniversityChengdu, KínaNo longer taking part
- The First Peoples Hospital of ChenzhouChenzhou, KínaNo longer taking part
- Daping Hospital, Third Military Medical UniversityChongqing, KínaNo longer taking part
- Xinqiao Hospital Affiliated to the Army Medical UniversityChongqing, KínaNo longer taking part
- First Affiliated Hospital of Dalian Medical UniversityDalian, KínaNo longer taking part
- Fujian Cancer HospitalFuzhou, KínaNo longer taking part
- Fujian Provincial HospitalFuzhou, KínaNo longer taking part
- Cancer Center of Guangzhou Medical UniversityGuangzhou, KínaNo longer taking part
- Guangdong Provincial Peoples HospitalGuangzhou, KínaNo longer taking part
- Nanfang Hospital of Southern Medical UniversityGuangzhou, KínaNo longer taking part
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, KínaNo longer taking part
- Zhejiang Cancer HospitalHangzhou, KínaNo longer taking part
- Harbin Medical University Cancer HospitalHarbin, KínaNo longer taking part
- Anhui Provincial Cancer Hospital aka West Branch of Anhui Province HospitalHefei, KínaNo longer taking part
- The Second Hospital University of South ChinaHengyang, KínaNo longer taking part
- Jinan Central HospitalJinan, KínaNo longer taking part
- Shandong Cancer HospitalJinan, KínaNo longer taking part
- Yunnan Cancer HospitalKunming, KínaNo longer taking part
- The First Hospital of Lanzhou UniversityLanzhou, KínaNo longer taking part
- The First Affiliated Hospital of Nanchang University Branch DonghuNanchang, KínaNo longer taking part
- The Second Affiliated Hospital of Nanchang UniversityNanchang, KínaNo longer taking part
- Nanjing First HospitalNanjing, KínaNo longer taking part
- Zhongda Hospital Southeast UniversityNanjing, KínaNo longer taking part
- The Peoples Hospital of Guangxi Zhuang Autonomous RegionNanning, KínaNo longer taking part
- The Tumor Hospital Affiliated to Guangxi Medical UniversityNanning, KínaNo longer taking part
- The Affiliated Hospital of Qingdao University Branch LaoshanQingdao, KínaNo longer taking part
- Affiliated Zhongshan Hospital of Fudan UniversityShanghai, KínaNo longer taking part
- Huashan Hospital Affiliated to Fudan UniversityShanghai, KínaNo longer taking part
- Rui Jin Hospital Shanghai Jiao Tong University School of MedicineShanghai, KínaNo longer taking part
- Cancer Hospital of Shantou University Medical CollegeShantou, KínaNo longer taking part
- Cancer Hospital Chinse Academy of Medical Sciences, Shenzhen CenterShenzhen, KínaNo longer taking part
- Liaoning Cancer Hospital and InstituteShenyang, KínaNo longer taking part
- The First Affiliated Hospital of Soochow UniversitySuzhou, KínaNo longer taking part
- The Second Affiliated Hospital of Soochow UniversitySuzhou, KínaNo longer taking part
- Taizhou Hospital of ZhejiangTaizhou, KínaNo longer taking part
- Tianjin Medical University Cancer Institute and HospitalTianjin, KínaNo longer taking part
- Tianjin Medical University General HospitalTianjin, KínaNo longer taking part
- Affiliated Cancer Hospital of Xinjiang Medical UniversityÜrümqi, KínaNo longer taking part
- Hubei Cancer HospitalWuhan, KínaNo longer taking part
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyWuhan, KínaNo longer taking part
- Union Hospital of Tongji Medical College Huazhong University of Science and TechnologyWuhan, KínaNo longer taking part
- The First Affiliated hospital of Xiamen UniversityXiamen, KínaNo longer taking part
- The affiliated hospital of xuzhou medical universityXuzhou, KínaNo longer taking part
- General Hospital of Ningxia Medical UniversityYinchuan, KínaNo longer taking part
- Henan Cancer HospitalZhengzhou, KínaNo longer taking part
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, KínaNo longer taking part
Trial details
- Who runs it
- BeiGene
- Trial code
- NCT04921358
- Record updated
- 2025. június 29.
- 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).