Study on Tislelizumab with New Treatments for Non-Small Cell Lung Cancer
Sponsor: BeiGene
ClinicalTrials ID:NCT05635708
This clinical trial is testing the effectiveness and safety of the drug Tislelizumab, combined with other new treatments, for patients with non-small cell lung cancer (NSCLC). The study is divided into two parts based on the level of a specific protein (PD-L1) in the cancer cells.
Patient Parameters
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Program Overview
The aim of this study is to evaluate how well Tislelizumab, when used with other investigational drugs, works against non-small cell lung cancer (NSCLC). The study also looks at the safety and tolerability of these treatments, with or without chemotherapy. It is organized into two sub-studies: one for patients whose cancer cells have high levels of the PD-L1 protein (50% or more) and another for those with low or no PD-L1 protein (less than 50%).
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is either locally advanced, has come back, or has spread to other parts of the body, and cannot be treated with surgery or radiation.
- Have not received any previous systemic treatment for metastatic NSCLC. Previous chemotherapy or radiation for locally advanced cancer is allowed if it was completed at least 6 months before joining the study.
- Have a tumor that can be tested for PD-L1 protein levels, either from a previous sample or a new biopsy. Patients must know their PD-L1 status to participate.
- Have at least one tumor that can be measured using standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have a type of lung cancer that includes small cell lung cancer.
- Have known genetic mutations in the cancer that can be treated with specific targeted therapies.
- Have previously received treatments that target PD-1, PD-L1, or other similar immune pathways, unless it was part of a previous treatment completed more than 6 months ago.
- Have used Chinese herbal or patent medicines for cancer control within 14 days before joining the study.
- Have active cancer spread to the brain or spinal fluid, or have uncontrolled autoimmune diseases.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Memorial Sloan Kettering Cancer Center Mskcc | 10065 | New York | New York |
| Providence Portland Medical Center | 97213 | Portland | Oregon |
| Oncology and Hematology Care Clinic Westside | 97225-9722 | Portland | Oregon |
| The University of Texas Md Anderson Cancer Center | 77030-4009 | Houston | Texas |
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