Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04921358|
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : February 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer (NSCLC)||Drug: Tislelizumab Drug: Docetaxel Drug: Sitravatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SAFFRON-301: 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|
|Actual Study Start Date :||July 27, 2021|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: Arm A: Tislelizumab in combination with Sitravatinib
tislelizumab 200 mg intravenously once every 3 weeks in combination with sitravatinib 100 mg orally once a day
Active Comparator: Arm B: Docetaxel
docetaxel 75 mg/m2 intravenously once every 3 weeks
- Overall survival (OS) [ Time Frame: From first randomization up to 35 months, approximately ]OS is defined as the time from randomization to the date of death due to any reason.
- Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) [ Time Frame: From first randomization up to 35 months, approximately ]defined as the time from randomization to the first occurrence of disease progression as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first
- Progression-free survival (PFS) [ Time Frame: From first randomization up to 35 months, approximately ]defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
- Overall response rate (ORR) [ Time Frame: From first randomization up to 35 months, approximately ]defined as the proportion of participants with partial response or complete response as determined by the IRC based on RECIST v1.1
- Duration of Response (DOR) [ Time Frame: From first randomization up to 35 months, approximately ]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
- Disease control rate (DCR) [ Time Frame: From first randomization up to 35 months, approximately ]defined as the proportion of participants whose best overall response (BOR) is complete response, partial response or stable disease as determined by the IRC based on RECIST v1.1
- Health-related quality of life (HRQoL) as assessed according to the European Organization and Treatment of Cancer lung cancer module, QLQ-LC13 [ Time Frame: From first randomization up to 35 months, approximately ]A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
- Health-related quality of life (HRQoL) as assessed according to the European Organization for Research and Treatment of Cancer (EORTC) core cancer (QLQ-C30) [ Time Frame: From first randomization up to 35 months, approximately ]The EORTC QLQ-C30 is completed by the participant. 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) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
- Health-related quality of life (HRQoL) as assessed according to the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) [ Time Frame: From first randomization up to 35 months, approximately ]Participant-reported outcomes based on EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) for all cohorts The EQ-5D- is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system has two versions, namely the 3L and 5L, both involving five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). In the EQ-5D-5L that will be used, participants may choose from the following five response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health.
- Number of participants experiencing treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 [ Time Frame: From first randomization up to 35 months, approximately ]
- Plasma concentration of sitravatinib [ Time Frame: From first randomization up to 35 months, approximately ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Metastatic or unresectable locally advanced histologicallyor 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
Key Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921358
|Other Study ID Numbers:||
2022-001779-15 ( EudraCT Number )
SAFFRON-301 ( Other Identifier: BeiGene )
|First Posted:||June 10, 2021 Key Record Dates|
|Last Update Posted:||February 9, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action