Brain Tumor Clinical Trial
Official title:
A Randomized Pivotal Study Assessing the Efficacy of Targeted Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy.
This is a prospective, multi-center, randomized, two-arm, controlled, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned pembrolizumab monotherapy for their primary disease. The study will be conducted at up to 20 centers in the US. The immunotherapy regimen (every 3 weeks for 6 cycles) of pembrolizumab is per the FDA approved labeling for pembrolizumab (Keytruda®) and the subjects prescribed standard of care therapy for their primary NSCLC. The study aims to demonstrate superiority of Exablate BBBD targeted to their brain metastases over the standard of care without Exablate BBBD with respect to the percentage of subjects achieving Objective Response Rate (ORR) by 6 months follow-up. ;
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