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

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.

Trial Details

NCT ID
NCT05317858
Phase
PHASE3
Sponsor
InSightec
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Blood Brain Barrier Opening - Oncology
  • Pembrolizumab
  • Atezolizumab
  • Cemiplimab
  • Nivolumab
  • Iptilimumab
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Newport Beach, California, United States|33.61891,-117.92895
  • Miami, Florida, United States|25.77427,-80.19366
  • Tampa, Florida, United States|27.94752,-82.45843
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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