Evaluating Osimertinib With Early Stereotactic Radiosurgery Versus Osimertinib Alone in Patients With EGFR-Mutated NSCLC and Asymptomatic Brain Metastases

What this Trial Is About

Researchers are investigating treatments for patients with EGFR-mutated non-small cell lung cancer NSCLC who have brain metastases that do not cause symptoms. This open-label randomized study compares continuing treatment with Osimertinib alone to combining Osimertinib with early stereotactic radiosurgery SRS to brain metastases. Osimertinib is a targeted therapy that crosses the blood-brain barrier and controls most brain metastases, but some remain visible on MRI two months after starting treatment. The study aims to see if adding early SRS improves brain control, cognitive function, and possibly overall survival. Participants will first receive Osimertinib for two months. Brain MRI scans will be done before starting and after two months of Osimertinib. Those still showing brain metastases without symptoms will be randomly assigned to either continue Osimertinib alone or receive SRS plus Osimertinib. The SRS is delivered as a precise radiation treatment to the brain lesions. Both groups will be followed regularly with scans and assessments. During the study, participants will undergo brain and whole-body imaging every three months after randomization to monitor disease progression. Researchers will also assess cognitive function, quality of life, time until whole brain radiation is needed, and overall survival. Close follow-up will help evaluate how well the treatments control the cancer in the brain and body, and their effects on patients wellbeing over time.

A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases