Phase II Randomized Study Comparing Radiotherapy Plus Immune Checkpoint Inhibitor Therapy to Standard Chemotherapy in Adults with Metastatic or Recurrent Non-Small Cell Lung Cancer Previously Treated with Immunotherapy

What this Trial Is About

Researchers are evaluating a combination of immunotherapy and radiotherapy in patients with metastatic or recurrent non-small cell lung cancer NSCLC who have previously been treated with immunotherapy. This Phase II randomized study compares the effects of radiotherapy plus immune checkpoint inhibitor therapy with standard chemotherapy. The goal is to assess progression-free survival and other outcomes over an extended period. Participants are assigned to one of two groups one receives standard immunotherapy chosen by the investigator combined with radiation treatment, while the other receives standard chemotherapy selected by the investigator. Immunotherapy examples include pembrolizumab, cemiplimab, durvalumab, or combinations like ipilimumab plus nivolumab, and chemotherapy options include docetaxel with or without ramucirumab, gemcitabine, or other recommended treatments. Radiotherapy follows usual clinical practice, targeting tumors suitable for ablative treatment. Throughout the study, participants will undergo assessments such as imaging to measure tumor response, survival monitoring, and evaluation of treatment safety and pharmacodynamics. Researchers will also explore correlations between specific genetic elements and clinical response. The overall study duration includes up to 48 months of follow-up to track progression-free and overall survival, with shorter-term safety evaluations during the initial months of combined treatment.

A Study Evaluating The Combination of Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer