Study Comparing Pembrolizumab Alone Versus Pembrolizumab with Sacituzumab Govitecan for Metastatic Non-small Cell Lung Cancer with High PD-L1 Levels
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT05609968
This clinical trial is comparing two treatments for adults with metastatic non-small cell lung cancer (NSCLC) that have high levels of PD-L1. The study aims to see which treatment is more effective in slowing down the cancer and improving survival.
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Program Overview
The purpose of this study is to compare the effectiveness of two treatments for metastatic non-small cell lung cancer (NSCLC) in adults. One group will receive pembrolizumab alone, while the other group will receive a combination of pembrolizumab and sacituzumab govitecan. The study will measure how long patients live without the cancer getting worse and their overall survival. This will be assessed by independent reviewers using specific criteria for evaluating solid tumors.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with metastatic non-small cell lung cancer (NSCLC).
- Cancer does not require specific treatments targeting EGFR, ALK-1, or ROS-1.
- Tumor tests show PD-L1 levels of 50% or higher.
- Expected to live at least 3 more months.
Exclusion Criteria
- Have had another cancer unless treated and cancer-free for 3 years.
- Have had chemotherapy or other cancer treatments for metastatic NSCLC.
- Have used Topoisomerase 1 inhibitors or Trop-2 targeted therapy before.
- Have had treatments targeting PD-1, PD-L1, or PD-L2 proteins.
- Have had radiation therapy within 2 weeks before starting the study or have side effects from radiation needing steroids.
- Have had more than 30 Gray of radiation to the lungs in the last 6 months.
- Have had a live vaccine within 30 days before starting the study.
- Have used experimental drugs or devices within 4 weeks before the study.
- Have heart problems like recent heart attack, serious arrhythmias, or severe heart failure.
- Have active inflammatory bowel disease.
- Have immune system issues or are on long-term steroids or immunosuppressants.
- Have active brain cancer spread or meningitis.
- Have severe allergies to pembrolizumab or sacituzumab govitecan.
- Have active autoimmune diseases needing treatment in the last 2 years.
- Have lung diseases like pneumonitis needing steroids.
- Have active infections needing treatment.
- Have HIV, hepatitis B, or active hepatitis C.
- Have any condition or treatment that could interfere with the study or is not in the participant's best interest.
- Have not fully recovered from major surgery or have ongoing surgical issues.
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