drugset / Trial / NCT05317858

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

NCT05317858

Phase 3 Recruiting 30 enrolled InSightec
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-08-12
Primary completion
2027-06-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Background Atezolizumab Monoclonal antibody
Background Cemiplimab Monoclonal antibody
Background Iptilimumab Unknown
Background Nivolumab Monoclonal antibody
Background Pembrolizumab Monoclonal antibody