RecruitingBrain TumorNon Small Cell Lung Cancer
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
Eligible age
18–100 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: InSightec
You may qualify if…
- ✓ 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 radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and/or if in the opinion of the Investigator, the subject may benefit from the study procedure.
- ✓ Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day.
- ✓ Screening/Baseline laboratory values Screening/Baseline should adhere to local standard of care lab values for ICI therapy
You may not qualify if…
- ✕ Participant has evidence of acute intracranial hemorrhage
- ✕ Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).
- ✕ Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.
- ✕ Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.
- ✕ History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.
- ✕ Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the opinion of the investigator, interfere with the subject receiving the study therapy or procedures or otherwise impact their participation in the trial.
- ✕ Subjects with evidence of cranial or systemic infection.
- ✕ Participant has received a solid organ or hematopoietic stem cell transplant.
Where it's recruiting
Arizona
Phoenix
California
Newport Beach
Florida
Fort Lauderdale · Miami · Tampa
Maryland
Baltimore
North Carolina
Winston-Salem
Oregon
Portland
Rhode Island
Providence
Virginia
Richmond
Source: ClinicalTrials.gov · NCT05317858 · last updated 2026-08-19