Phase III Study of Immunotherapy with or without Local Ablative Treatment for Oligometastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating first-line immunotherapy-based standard treatments combined with local ablative therapies for patients with oligometastatic non-small cell lung cancer NSCLC. This phase III randomized study aims to compare overall survival and other important outcomes between different treatment approaches for patients with limited metastatic disease. The study is conducted across multiple centers and sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Participants will be randomly assigned to one of two groups. One group will receive radical local treatment RLT targeting all metastatic sites using options such as stereotactic body radiation therapy SBRT, interventional radiology, or minimally invasive surgery, along with standard care SoC-based immunotherapy with or without chemotherapy every three weeks. The control group will receive only the SoC-based immunotherapy with or without chemotherapy. RLT should be completed within three months after randomization and should not delay immunotherapy. Curative treatments for the primary tumor and lymph nodes may be given during the maintenance phase. Throughout the study, participants will undergo regular assessments including imaging to measure progression-free survival and immune-related progression-free survival, quality of life questionnaires specific to lung cancer, and laboratory measures such as circulating tumor DNA clearance. Side effects will be monitored using standard criteria, and an economic evaluation will be conducted. The main outcome is overall survival measured up to two years after the last patient is randomized or death. Participants will be followed with scheduled visits, treatments, and evaluations during the study period.

First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients.