Study Comparing Ociperlimab and Tislelizumab with Pembrolizumab for Untreated Lung Cancer
Sponsor: BeiGene
ClinicalTrials ID:NCT04746924
This clinical trial is testing a new combination of drugs, ociperlimab and tislelizumab, against pembrolizumab to see which is more effective and safe for adults with advanced or untreated lung cancer that has high levels of PD-L1 protein.
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Program Overview
The aim of this study is to compare the effectiveness and safety of a new drug combination, ociperlimab and tislelizumab, with pembrolizumab in adults who have advanced or untreated non-small cell lung cancer (NSCLC) with high PD-L1 protein levels. This study is for patients whose cancer has either spread or returned and cannot be treated with surgery or radiation alone.
Eligibility Criteria
Inclusion Criteria
- Have advanced or returning non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation alone.
- Have not received any previous treatment for metastatic NSCLC.
- Agree to provide a sample of tumor tissue for testing.
- Have tumors with high levels of PD-L1 protein (at least 50% of tumor cells).
- Have at least one tumor that can be measured by scans.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have known genetic mutations in specific cancer-related genes like EGFR, ALK, BRAF V600E, or ROS1.
- Have previously received treatments targeting specific immune checkpoints or T-cell pathways.
- Have active cancer spread to the brain or spinal cord that is not controlled or treated.
- Have active autoimmune diseases or a history of autoimmune diseases that could flare up again.
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