Study on Pembrolizumab With or Without Chemotherapy and Additional Treatments for Advanced Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06731907
This clinical trial is exploring new treatment options for advanced non-small cell lung cancer (NSCLC) that has not been treated before. The study is testing the effectiveness of adding new treatments to the standard immunotherapy drug pembrolizumab, with or without chemotherapy.
Patient Parameters
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Program Overview
Researchers are looking into new ways to treat advanced non-small cell lung cancer (NSCLC), which is the most common type of lung cancer and often cannot be removed by surgery. The standard treatment includes immunotherapy, like pembrolizumab, and chemotherapy. This study aims to see if adding other treatments, such as a drug called patritumab deruxtecan, can improve the effectiveness of pembrolizumab, with or without chemotherapy. The main goals are to check the safety and effectiveness of these treatments.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Stage IV non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Provide a tumor tissue sample from a biopsy.
- If HIV-positive, must have well-controlled HIV with antiretroviral therapy.
- If positive for hepatitis B, must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load before starting treatment.
Exclusion Criteria
- Have small cell lung cancer or a mix of small cell and non-small cell lung cancer.
- Have squamous NSCLC with certain genetic mutations (EGFR, ALK, or ROS1).
- Have HIV with a history of certain related diseases.
- Have severe lung problems from other illnesses or conditions.
- Have cancer that has spread to the brain or spinal cord lining.
- Have certain neurological or eye conditions.
- Have had a heart attack or severe heart problems recently.
- Have uncontrolled heart rhythm issues.
- Have had certain heart surgeries recently.
- Have not waited long enough after previous cancer treatments before starting this study.
- Have had certain previous cancer treatments, including specific chemotherapy or immunotherapy.
- Have had recent radiation therapy to the lung or other areas.
- Have received a live vaccine recently.
- Have an immune system deficiency or are on immunosuppressive therapy.
- Have another active cancer or infection.
- Have active hepatitis B and C infections.
- Have not fully recovered from major surgery.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MedStar Franklin Square Medical Center ( Site 0033) | 21237 | Baltimore | Maryland |
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