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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04921358




Registration number
NCT04921358
Ethics application status
Date submitted
25/05/2021
Date registered
10/06/2021

Titles & IDs
Public title
Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
Secondary ID [1] 0 0
2022-001779-15
Secondary ID [2] 0 0
BGB-A317-Sitravatinib-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
From first randomization up to 35 months, approximately
Primary outcome [2] 0 0
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
Timepoint [2] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [2] 0 0
Overall response rate (ORR)
Timepoint [2] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [4] 0 0
Disease control rate (DCR)
Timepoint [4] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [5] 0 0
Health-related quality of life (HRQoL) as assessed according to the European Organization and Treatment of Cancer lung cancer module, QLQ-LC13
Timepoint [5] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [6] 0 0
Health-related quality of life (HRQoL) as assessed according to the European Organization for Research and Treatment of Cancer (EORTC) core cancer (QLQ-C30)
Timepoint [6] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [7] 0 0
Health-related quality of life (HRQoL) as assessed according to the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L)
Timepoint [7] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
From first randomization up to 35 months, approximately
Secondary outcome [9] 0 0
Plasma concentration of sitravatinib
Timepoint [9] 0 0
From first randomization up to 35 months, approximately

Eligibility
Key inclusion criteria
Key

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2023
Sample size
Target
Accrual to date
Final
377
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [5] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [6] 0 0
Cairns Hospital - Cairns
Recruitment hospital [7] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [8] 0 0
Monash Health - Clayton
Recruitment hospital [9] 0 0
The Northern Hospital - Epping
Recruitment hospital [10] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [11] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3076 - Epping
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
Chongqing
Country [4] 0 0
China
State/province [4] 0 0
Fujian
Country [5] 0 0
China
State/province [5] 0 0
Gansu
Country [6] 0 0
China
State/province [6] 0 0
Guangdong
Country [7] 0 0
China
State/province [7] 0 0
Guangxi
Country [8] 0 0
China
State/province [8] 0 0
Heilongjiang
Country [9] 0 0
China
State/province [9] 0 0
Henan
Country [10] 0 0
China
State/province [10] 0 0
Hubei
Country [11] 0 0
China
State/province [11] 0 0
Hunan
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Jiangxi
Country [14] 0 0
China
State/province [14] 0 0
Jilin
Country [15] 0 0
China
State/province [15] 0 0
Liaoning
Country [16] 0 0
China
State/province [16] 0 0
Ningxia
Country [17] 0 0
China
State/province [17] 0 0
Shandong
Country [18] 0 0
China
State/province [18] 0 0
Shanghai
Country [19] 0 0
China
State/province [19] 0 0
Sichuan
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
China
State/province [21] 0 0
Xinjiang
Country [22] 0 0
China
State/province [22] 0 0
Yunnan
Country [23] 0 0
China
State/province [23] 0 0
Zhejiang

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04921358