Study on New Immunotherapy Combinations for Untreated Advanced or Metastatic Non-Small-Cell Lung Cancer
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT05565378
This clinical trial is testing new combinations of immunotherapy drugs to see if they are more effective than a single immunotherapy drug in treating patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that has not been treated before.
Patient Parameters
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Program Overview
The study aims to evaluate the effectiveness and safety of new combinations of immunotherapy drugs compared to a single immunotherapy drug in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that has not been treated before. The study focuses on patients whose tumors have high levels of a protein called PD-L1. The drug being tested is called Belrestotug.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced non-small-cell lung cancer (NSCLC) that cannot be removed by surgery or treated with radiation alone.
- Have not received any previous treatment for advanced or metastatic NSCLC.
- Able to provide a recent tumor sample for testing.
- Tumors must have high levels of PD-L1 (a protein that helps cancer cells hide from the immune system).
- Have measurable cancer that can be tracked using standard criteria.
- 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.
- Have adequate organ function as determined by specific medical tests.
- Female participants who can become pregnant must agree to use effective birth control.
Exclusion Criteria
- Have specific genetic mutations in the cancer that can be treated with approved therapies.
- Have had major surgery within the last 4 weeks or significant lung radiation within the last 6 months.
- Have received any previous treatment with immune checkpoint inhibitors.
- Have never smoked or smoked fewer than 100 cigarettes in their lifetime.
- Have had another invasive cancer within the last 5 years, with some exceptions.
- Have untreated or worsening brain cancer or cancer in the membranes around the brain.
- Have an autoimmune disease that required treatment in the last 2 years.
- Are taking medications that suppress the immune system.
- Have received a live vaccine within 30 days before starting the study.
- Have a history of lung diseases like pulmonary fibrosis or pneumonitis.
- Have had heart problems in the last 6 months.
- Have unstable liver or bile duct disease.
- Have had a severe infection in the last 4 weeks.
- Test positive for tuberculosis, HIV, hepatitis B, or hepatitis C.
- Have advanced cancer that is causing life-threatening complications.
- Are currently in another clinical trial or have been in one within the last 4 weeks.
- Have had a tissue or organ transplant.
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