Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
This is a randomised trial with three arms. In Arm A (Experimental), participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks. In Arm B (Active comparator), Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks. In Arm C (Placebo comparator), Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Conditions
This trial is treating people with Non-Small Cell Lung Cancer
Eligibility
Inclusion
- Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.
- No prior systemic treatment for metastatic NSCLC.
- Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
- Tumors with PD-L1 expressed in ≥ 50% tumor cells.
- At least 1 measurable lesion as defined per RECIST v1.1.
- ECOG Performance Status ≤ 1.
Exclusion
- Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
- Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- You have had a certain type of treatment or surgical procedure.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
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:
- NCT04746924 *
- BEIGENE, BGB-A317-A1217-302, TIGIT-302, CT1363, BGB-302
Trial sponsor
BeiGene Australia Pty Ltd
Scientific Title
A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
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