Study Comparing Pembrolizumab/Vibostolimab Combination Therapy to Pembrolizumab Alone for Treating PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT04738487
This clinical trial is testing whether a combination of two drugs, pembrolizumab and vibostolimab, is more effective than pembrolizumab alone in treating patients with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive.
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Program Overview
Researchers are exploring new treatments for people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. Metastatic means the cancer has spread to other parts of the body, and PD-L1 positive means the cancer cells have a protein that helps them hide from the immune system. The study aims to find out if patients live longer and have better outcomes when treated with a combination of vibostolimab and pembrolizumab compared to pembrolizumab alone.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Stage IV non-small cell lung cancer (NSCLC) that has spread to other parts of the body.
- Have measurable cancer that can be tracked using standard criteria.
- Not suitable for certain targeted therapies based on specific genetic tests.
- Cancer cells must show PD-L1 expression in at least 1% of cells.
- 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 a life expectancy of at least 3 months.
- Female participants must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have a history of another cancer unless it was treated successfully and has not returned for at least 3 years.
- Have received previous treatments for metastatic NSCLC, except for certain therapies completed at least 6 months before the current diagnosis.
- Have had previous treatments targeting PD-1, PD-L1, or similar pathways.
- Have received radiation therapy within 2 weeks before starting the study treatment.
- Have received a live vaccine within 30 days before starting the study treatment.
- Currently participating in another clinical trial or have used an investigational device recently.
- Have untreated or active cancer spread to the brain or spinal cord.
- Have severe allergies to the study drugs or their ingredients.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have a diagnosis of immunodeficiency or are on high-dose steroids or other immunosuppressive treatments.
- Have a history of lung inflammation or current lung disease.
- Have an active infection needing treatment.
- Have a history of HIV, Hepatitis B, or active Hepatitis C.
- Have any condition or treatment that would interfere with the study or is not in the participant's best interest, according to the study doctor.
- Have a psychiatric or substance abuse disorder that would affect participation in the study.
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