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
InSightec
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.
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…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is ≥ 18 years of age * The participant provides written informed consent for the trial * Participant is willing to comply with all study procedures for the duration of the study * Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2 * Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radi…
Interventions
- DeviceBlood Brain Barrier Opening - Oncology
BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
- DrugPembrolizumab
Pembrolizumab infusion
- DrugAtezolizumab
Atezolizumab infusion
- DrugCemiplimab
Cemiplimab infusion
- DrugNivolumab
Nivolumab infusion
- DrugIptilimumab
Iptilimumab infusion
Locations (10)
- St. Joseph's Hospital and Medical CenterPhoenix, Arizona
- Miami Cancer Institute at Baptist HealthMiami, Florida
- Moffitt Cancer CenterTampa, Florida
- University of MarylandBaltimore, Maryland
- Atrium Health Wake Forest BaptistWinston-Salem, North Carolina
- Oregon Health & Science UniversityPortland, Oregon