Study Stopped
Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.
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
4 other identifiers
interventional
377
2 countries
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2021
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedStudy Start
First participant enrolled
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedResults Posted
Study results publicly available
June 29, 2025
CompletedJune 29, 2025
June 1, 2025
2.4 years
May 25, 2021
November 25, 2024
June 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)
Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.
Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Defined as the time from randomization until first documentation of disease progression as assessed by the IRC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.
Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Secondary Outcomes (8)
Progression Free Survival (PFS) as Assessed by the Investigator
Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Overall Response Rate (ORR)
Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Duration of Response (DOR)
Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Disease Control Rate (DCR)
Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores
Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)
- +3 more secondary outcomes
Study Arms (2)
Tislelizumab + Sitravatinib
EXPERIMENTALParticipants 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.
Docetaxel
ACTIVE COMPARATORParticipants received 75 mg/m² of intravenous docetaxel once every 3 weeks until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.
Interventions
200 mg intravenously once every 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has received docetaxel as monotherapy or in combination with other therapies.
- Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (\> 50 mL/day)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (61)
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148, Australia
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
The Tweed Valley Hospital
Cudgen, New South Wales, 2487, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Pindara Private Hospital
Benowa, Queensland, 4217, Australia
Cancer Research South Australia
Adelaide, South Australia, 5000, Australia
Monash Health
Clayton, Victoria, 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Xinqiao Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, 400037, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Cancer Hospital Chinse Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518116, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Peoples Hospital of Chenzhou
Chenzhou, Hunan, 423000, China
The Second Hospital, University of South China
Hengyang, Hunan, 430407, China
Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
Changzhou, Jiangsu, 213003, China
Nanjing First Hospital
Nanjing, Jiangsu, 210009, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Affiliated Hospital of Qingdao University Branch Laoshan
Qingdao, Shandong, 266000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, 317000, China
Related Publications (2)
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.
BACKGROUNDZhou Q, Gao B, et al. SAFFRON-301: Sitravatinib PLUS Tislelizumab in Advanced/Metastatic NSCLC Progressing on/after Chemotherapy and Anti-PD-(L)1.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2021
First Posted
June 10, 2021
Study Start
July 27, 2021
Primary Completion
December 20, 2023
Study Completion
December 20, 2023
Last Updated
June 29, 2025
Results First Posted
June 29, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share