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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 2, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07293247). This is a study registration, not published results. Lead sponsor: Alliance for Clinical Trials in Oncology. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 164 participants (ESTIMATED). Conditions: Lung Non-Small Cell Carcinoma. Interventions: DRUG: Chemotherapy; OTHER: Immunotherapy; RADIATION: Intensity-Modulated Radiation Therapy; PROCEDURE: Computed Tomography; PROCEDURE: Magnetic Resonance Imaging; OTHER: Fludeoxyglucose F-18; PROCEDURE: Biospecimen Collection. Primary outcome measures: Disease-free survival (DFS) , Time from the date of randomization to the date of earliest disease recurrence/progression or deaths of all causes, assessed up to 5 years; Incidence of late grade ≥ 3 cardiopulmonary toxicities , Between 3 and 24 months after protocol therapy. Brief summary: This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.