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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04921358
Registration number
NCT04921358
Ethics application status
Date submitted
25/05/2021
Date registered
10/06/2021
Date last updated
28/02/2024
Titles & IDs
Public title
Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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Scientific 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
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Secondary ID [1]
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2022-001779-15
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Secondary ID [2]
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BGB-A317-Sitravatinib-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC)
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Docetaxel
Treatment: Drugs - Sitravatinib
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
Treatment: Drugs: Tislelizumab
administered intravenously
Treatment: Drugs: Docetaxel
administered intravenously
Treatment: Drugs: Sitravatinib
administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to the date of death due to any reason.
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Timepoint [1]
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From first randomization up to 35 months, approximately
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Primary outcome [2]
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Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
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Assessment method [2]
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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
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Timepoint [2]
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From first randomization up to 35 months, approximately
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Secondary outcome [1]
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Progression-free survival (PFS)
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Assessment method [1]
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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
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Timepoint [1]
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From first randomization up to 35 months, approximately
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Secondary outcome [2]
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Overall response rate (ORR)
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Assessment method [2]
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defined as the proportion of participants with partial response or complete response as determined by the IRC based on RECIST v1.1
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Timepoint [2]
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From first randomization up to 35 months, approximately
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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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
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Timepoint [3]
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From first randomization up to 35 months, approximately
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Secondary outcome [4]
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Disease control rate (DCR)
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Assessment method [4]
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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
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Timepoint [4]
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From first randomization up to 35 months, approximately
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Secondary outcome [5]
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Health-related quality of life (HRQoL) as assessed according to the European Organization and Treatment of Cancer lung cancer module, QLQ-LC13
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Assessment method [5]
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A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
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Timepoint [5]
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From first randomization up to 35 months, approximately
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Secondary outcome [6]
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Health-related quality of life (HRQoL) as assessed according to the European Organization for Research and Treatment of Cancer (EORTC) core cancer (QLQ-C30)
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Assessment method [6]
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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).
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Timepoint [6]
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From first randomization up to 35 months, approximately
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Secondary outcome [7]
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Health-related quality of life (HRQoL) as assessed according to the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L)
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Assessment method [7]
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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.
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Timepoint [7]
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From first randomization up to 35 months, approximately
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Secondary outcome [8]
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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
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Assessment method [8]
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Timepoint [8]
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From first randomization up to 35 months, approximately
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Secondary outcome [9]
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Plasma concentration of sitravatinib
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Assessment method [9]
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Timepoint [9]
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From first randomization up to 35 months, approximately
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Eligibility
Key inclusion criteria
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1. Metastatic or unresectable locally advanced histologicallyor cytologically confirmed
Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Has received docetaxel as monotherapy or in combination with other therapies.
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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/12/2023
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Sample size
Target
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Accrual to date
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Final
377
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Blacktown Cancer and Haematology Centre - Blacktown
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Recruitment hospital [2]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [3]
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St George Hospital - Kogarah
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Recruitment hospital [4]
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [5]
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Pindara Private Hospital - Benowa
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Recruitment hospital [6]
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Cairns Hospital - Cairns
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Recruitment hospital [7]
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Cancer Research South Australia - Adelaide
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Recruitment hospital [8]
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Monash Health - Clayton
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Recruitment hospital [9]
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The Northern Hospital - Epping
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Recruitment hospital [10]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [11]
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Sunshine Hospital - St Albans
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2485 - Tweed Heads
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Recruitment postcode(s) [5]
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4217 - Benowa
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Recruitment postcode(s) [6]
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4870 - Cairns
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3076 - Epping
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Recruitment postcode(s) [10]
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3065 - Fitzroy
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Recruitment postcode(s) [11]
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3021 - St Albans
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Anhui
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China
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State/province [2]
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Beijing
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China
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State/province [3]
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Chongqing
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Country [4]
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China
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State/province [4]
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Fujian
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China
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State/province [5]
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Gansu
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Country [6]
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China
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State/province [6]
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Guangdong
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Country [7]
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China
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State/province [7]
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Guangxi
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Country [8]
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China
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State/province [8]
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Heilongjiang
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China
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State/province [9]
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Henan
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China
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State/province [10]
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Hubei
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China
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State/province [11]
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Hunan
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China
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State/province [12]
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Jiangsu
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China
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State/province [13]
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Jiangxi
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China
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State/province [14]
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Jilin
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China
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State/province [15]
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Liaoning
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China
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State/province [16]
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Ningxia
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China
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Shandong
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China
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State/province [18]
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Shanghai
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China
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Sichuan
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China
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Tianjin
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China
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Xinjiang
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China
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Yunnan
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China
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State/province [23]
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Zhejiang
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of tislelizumab in
combination with sitravatinib compared with docetaxel in participants with locally advanced
or metastatic non-small cell lung cancer (NSCLC) who have disease progression following
platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell
death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination
with or sequentially before or after the platinum-based chemotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04921358
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04921358
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