Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT04921358
Last Updated: 2025-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
377 participants
INTERVENTIONAL
2021-07-27
2023-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tislelizumab + Sitravatinib
Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.
Tislelizumab
200 mg intravenously once every 3 weeks
Sitravatinib
100 mg orally once daily
Docetaxel
Participants received 75 mg/m² of intravenous docetaxel once every 3 weeks until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.
Docetaxel
75 mg/m\^2 intravenously once every 3 weeks
Interventions
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Tislelizumab
200 mg intravenously once every 3 weeks
Docetaxel
75 mg/m\^2 intravenously once every 3 weeks
Sitravatinib
100 mg orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
3. 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
4. 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.
5. 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)
6. At least 1 measurable lesion as defined based on RECIST v1.1 by investigator
Exclusion Criteria
2. Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (\> 50 mL/day)
3. 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.
4. Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
5. Active autoimmune diseases or history of autoimmune diseases that may relapse.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Campbelltown Hospital
Campbelltown, New South Wales, Australia
The Tweed Valley Hospital
Cudgen, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Cancer Hospital Chinse Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Peoples Hospital of Chenzhou
Chenzhou, Hunan, China
The Second Hospital, University of South China
Hengyang, Hunan, China
Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
Changzhou, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Jinan Central Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Branch Laoshan
Qingdao, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, China
Countries
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References
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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.
Zhou Q, Gao B, et al. SAFFRON-301: Sitravatinib PLUS Tislelizumab in Advanced/Metastatic NSCLC Progressing on/after Chemotherapy and Anti-PD-(L)1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-001779-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SAFFRON-301
Identifier Type: OTHER
Identifier Source: secondary_id
CTR20211410/CTR20211409
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-Sitravatinib-301
Identifier Type: -
Identifier Source: org_study_id
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