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Non-Small Cell Lung Cancer (NSCLC)Phase 3NCT04921358

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

A Phase 3 study testing Tislelizumab, Docetaxel and Sitravatinib in people with Non-Small Cell Lung Cancer (NSCLC), run by BeiGene at 61 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer (NSCLC)
What is being tested?
Tislelizumab, Docetaxel and Sitravatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
377 participants
Where
61 sitesin 2 countries
Study dates
27 Jul 2021to 20 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

61 sites in 2 countries.

61 sites in 2 countries

China52 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng

    Changzhou, Jiangsu, 213003

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The First Peoples Hospital of Chenzhou

    Chenzhou, Hunan, 423000

  • Xinqiao Hospital Affiliated to the Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • Daping Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui, 230088

  • The Second Hospital, University of South China

    Hengyang, Hunan, 430407

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210009

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021

  • The Affiliated Hospital of Qingdao University Branch Laoshan

    Qingdao, Shandong, 266000

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Cancer Hospital Chinse Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong, 518116

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Taizhou Hospital of Zhejiang

    Taizhou, Zhejiang, 317000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Australia9 sites

  • Cancer Research South Australia

    Adelaide, South Australia, 5000

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, 2148

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Monash Health

    Clayton, Victoria, 3168

  • The Tweed Valley Hospital

    Cudgen, New South Wales, 2487

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Sunshine Hospital

    St Albans, Victoria, 3021

Other trials in Australia

About this study

Official title: 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.

Being tested
Tislelizumab, Docetaxel, Sitravatinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

    200 mg intravenously once every 3 weeks

  • DocetaxelDrug

    75 mg/m^2 intravenously once every 3 weeks

  • SitravatinibDrug

    Also called BGB-9468

    100 mg orally once daily

Study groups in NCT04921358
Study groupRoleWhat they receive
Tislelizumab + SitravatinibExperimentalParticipants 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.
Receives: Drug: Tislelizumab; Drug: Sitravatinib
DocetaxelActive 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.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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)

  1. Progression Free Survival (PFS) as Assessed by the Investigator

    Defined as the time from randomization until first documentation of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.

    Measured: 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).

  2. Overall Response Rate (ORR)

    Defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the IRC per RECIST v1.1.

    Measured: 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).

  3. Duration of Response (DOR)

    Defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first.

    Measured: 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).

  4. Disease Control Rate (DCR)

    Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1.

    Measured: 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).

  5. 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

    The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.

    Measured: Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)

  6. Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales

    The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms.

    Measured: Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)

  7. Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS)

    The EQ-5D-5L comprises a descriptive module that includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a Visual Analogue Scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes.

    Measured: Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)

  8. Number of Participants With Adverse Events

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

    Measured: From the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start27 Jul 2021
  3. Primary completion20 Dec 2023
  4. Study completion20 Dec 2023

Why it stopped: Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04921358
Sponsor's protocol ID
BGB-A317-Sitravatinib-301
Other IDs
2022-001779-15, SAFFRON-301, CTR20211410/CTR20211409
Status last verified
Jun 2025
First submitted
25 May 2021
Last updated
29 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

  • Zhou Q, Gao B, Hu J, Zhao J, Wang M, He K, Zhang W, Liu C, Fang J, Li XY, Wang Z, Matos M, Kwatra V, Zheng W, Wang C, Chen Y, Zhang J, Wang J, Wu YL. SAFFRON-301: a randomised phase III study of sitravatinib in combination with tislelizumab in patients with locally advanced or metastatic non-small cell lung cancer. BMJ Oncol. 2026 Feb 19;5(1):e000890. doi: 10.1136/bmjonc-2025-000890. eCollection 2026.

    PubMed 41737914

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Docetaxel and Sitravatinib in people with Non-Small Cell Lung Cancer (NSCLC), run by BeiGene at 61 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04921358, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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