Evaluating Targeted Blood-Brain Barrier Opening with Exablate Focused Ultrasound Combined with Immune Checkpoint Therapy for Brain Metastases in Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of targeted blood-brain barrier opening using the Exablate Model 4000 Type 2 focused ultrasound system in patients with brain metastases from non-small cell lung cancer NSCLC. This clinical trial compares this approach combined with immune checkpoint inhibitor ICI therapy to standard ICI therapy alone. The study is a randomized, controlled, multi-center pivotal trial conducted in the US, aiming to improve response rates in brain metastases treatment. Participants will receive either the Exablate blood-brain barrier opening alongside planned FDA-approved on-label ICI systemic therapy or ICI therapy alone as the control. The ICI therapy is administered every 3 weeks for 6 cycles according to approved labeling. The Exablate BBB opening is done on the day of ICI infusion targeting the brain metastases. The trial will compare the objective response rate between these groups during a 6-month follow-up period. During the study, participants will undergo regular assessments including MRI scans to evaluate tumor response and monitoring of adverse events up to 6 months. Neuro-oncology brain metastases response assessments will also be done. Researchers will track safety and efficacy outcomes while participants continue their ICI therapy. The total study duration extends up to about 6 months with close follow-up throughout this period.

Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets