NCT05317858

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

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.

Detailed description

This is a prospective, multi-center, randomized, two-arm, controlled, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier opening using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors for their primary disease. The study will be conducted at up to 30 centers in the US. The immunotherapy regimen (every 3 weeks for 6 cycles) of prescribed ICI therapy is per the FDA approved labeling and the subjects prescribed standard of care therapy for their primary NSCLC. The study aims to demonstrate superiority of Exablate BBBO targeted to their brain metastases over the standard of care without Exablate BBBO with respect to the percentage of subjects achieving Objective Response Rate (ORR) by 6 months follow-up.

Conditions

• Brain Tumor
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DEVICE	Blood Brain Barrier Opening - Oncology	BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
DRUG	Pembrolizumab	Pembrolizumab infusion
DRUG	Atezolizumab	Atezolizumab infusion
DRUG	Cemiplimab	Cemiplimab infusion
DRUG	Nivolumab	Nivolumab infusion
DRUG	Iptilimumab	Iptilimumab infusion

Timeline

• Start date: 2022-08-12
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2022-04-08
• Last updated: 2026-04-16

Locations

10 sites across 3 countries: United States, Canada, South Korea

Regulatory

• FDA-regulated drug study
• FDA-regulated device study