A Phase II Randomized Controlled Trial of TKI Alone Versus TKI and Local Consolidative Radiation Therapy in Oncogene Driver Mutated Oligo Metastatic Non Small Cell Lung Cancer Patients

What this Trial Is About

Researchers are evaluating the effects of combining tyrosine kinase inhibitor (TKI) therapy with local consolidative radiation therapy (LCRT) versus TKI therapy alone in patients who have oncogene driver mutated oligo metastatic non-small cell lung cancer (NSCLC). This Phase II randomized controlled trial focuses on patients with specific gene mutations (EGFR or ALK/ROS) and limited metastatic disease to better understand treatment outcomes. Participants are randomly assigned to one of two groups in a 1:1 ratio. One group continues with standard TKI therapy alone, while the other group receives TKI therapy plus local consolidative radiation therapy targeting the primary tumor and 1 to 5 metastatic sites. Radiation is given to control the local and oligometastatic disease alongside ongoing TKI treatment. Throughout the study, participants undergo regular assessments including progression-free survival monitoring for up to 2 years. Secondary outcomes include overall survival, local disease control, health-related quality of life measured by specific questionnaires (EORTC-QLQ-C30 and EORTC-LC13), and tracking of radiation-related toxicities. Safety and health status are closely monitored, with data collected from the time of randomization up to 24 months or until death.

Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC