Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
People that are eligible to join this trial will be randomly allocated into one of two arms. In the experimental arm (Arm A), participants will receive 200mg intravenous tislelizumab once every three weeks, in combination with 100mg oral sitravatinib once a day. In the comparator arm (Arm B), participants will receive 75mg/m2 intravenous docetaxel once every three weeks. In both arms of the trial, treatment will be administered until progressive disease or intolerable toxicity.
Conditions
This trial is treating people with non-small cell lung cancer
Eligibility
Inclusion
- 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
Exclusion
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific 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
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