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Life sciences · Phase 2/3 Trial
ClinicalTrials.gov · October 1, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2/3 Trial.
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Registry record from ClinicalTrials.gov (NCT04929041). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 427 participants (ESTIMATED). Conditions: Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8. Interventions: PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; PROCEDURE: Echocardiography Test; BIOLOGICAL: Ipilimumab; PROCEDURE: Magnetic Resonance Imaging; BIOLOGICAL: Nivolumab; PROCEDURE: Positron Emission Tomography; OTHER: Quality-of-Life Assessment; RADIATION: Radiation Therapy. Primary outcome measures: Progression-free survival (PFS) (Phase II) , From randomization to disease progression or death of all causes, whichever comes first, assessed up to 5 years; Overall survival (OS) (Phase III) , From randomization and death of all causes, assessed up to 5 years. Brief summary: This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.