Study on Chemotherapy and Immunotherapy Followed by Radiation for Lung Cancer in Veterans
Sponsor: VA Office of Research and Development
ClinicalTrials ID:NCT06275360
This clinical trial is testing a combination of chemotherapy and immunotherapy, followed by radiation therapy, to see if it is safe and effective for patients with advanced lung cancer that cannot be removed by surgery.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a treatment plan that includes chemotherapy and immunotherapy, followed by radiation therapy, for patients with advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed. The trial is being conducted at multiple centers and involves patients who meet specific health criteria.
Eligibility Criteria
Inclusion Criteria
- Must be over 18 years old.
- Must have a good performance status, meaning able to carry out daily activities with little or no assistance.
- Must be eligible for treatment with both chemotherapy and radiation at the same time.
- Must have advanced lung cancer (Stage III NSCLC) that cannot be removed by surgery, as determined by a doctor or a team of specialists.
- Cancer must show a PD-L1 marker of 1% or higher.
- Must have cancer that can be measured using standard medical criteria.
- Must have good organ function based on medical tests.
- Must have available tumor tissue samples with enough cancer cells for analysis.
Exclusion Criteria
- Cannot have an active autoimmune disease that required treatment with immune-suppressing drugs in the past year.
- Cannot have uncontrolled immune system deficiencies, including HIV.
- Cannot be taking more than 10 mg of prednisone or equivalent steroids daily, except for supportive care.
- Cannot have tumors with specific genetic mutations (EGFR, ALK, ROS1, MET, or RET).
- Cannot have other serious health conditions that would prevent participation, as determined by a doctor.
- Cannot have had previous radiation or systemic treatment for advanced lung cancer.
- Cannot have psychiatric or substance abuse issues that would interfere with following the study requirements.
- Cannot be pregnant, breastfeeding, or planning to have children during the study and for 180 days after the last treatment.
- Cannot have a history of active tuberculosis.
- Cannot have active Hepatitis B or C.
- Cannot have received a live vaccine within 30 days before joining the study.
- Cannot have a diagnosis of Interstitial Lung Disease.
- Must be able to provide informed consent to participate in the study.
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