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Focused Ultrasound for NSCLC Brain Metastases

This study is testing a new way to treat brain tumors caused by non-small cell lung cancer (NSCLC). It uses a device called Exablate Focused Ultrasound to temporarily open the blood-brain barrier (a natural protective shield around the brain) at the same time you receive standard immunotherapy drugs like Pembrolizumab, Atezolizumab, Cemiplimab, or Nivolumab. Researchers want to see if opening this barrier helps the immunotherapy drugs work better against the brain tumors. You may be eligible if you are at least 18 years old, have NSCLC that has spread to your brain, and are already scheduled to receive one of these immunotherapy treatments. The study will look at side effects and how well the tumors respond over 6 months. The study is currently recruiting up to 30 participants.

Study design
This is a randomized study comparing treatment with the Exablate device plus immunotherapy to immunotherapy alone. It plans to enroll up to 30 participants across multiple centers.
What's involved
You would receive the Exablate treatment on the same day as your immunotherapy infusion. The study will monitor your health and tumor response for up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and tumor changes on MRI for up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05317858

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
InSightec
~30 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Blood Brain Barrier Opening - OncologyPembrolizumabAtezolizumabCemiplimabNivolumabIptilimumab

At a glance

Recruiting sites
8 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events
Measured over up to 6 months
+1 more outcome measured

Conditions

Brain Tumor
Non Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the Brain

Where it's being run

14 sites across 11 states
Florida3
South Korea2
Arizona1
California1
Maryland1
North Carolina1
Oregon1
Rhode Island1

Study leadership

  • Manmeet Ahluwalia, MD, MBA · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute, Baptist Health South Florida

Who to contact

Alyssa Voelker-Christy
[email protected]
817-948-5219
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

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.
Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate.
Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products.
Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI.
Subjects with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious))
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first on-study ICI infusion with or without Exablate. Note: prophylactic steroid use for ICI and chemotherapy infusion per institutional practice is allowed per protocol.
Has a known additional malignancy that requires active treatment that would interfere with study procedures.
Known presence of leptomeningeal disease.
Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Subject is currently enrolled in another intervention based clinical trial

What this trial measures

  • Adverse eventsup to 6 months

    Adverse events \[ Time Frame: Through study completion, up to 6 months\]. All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.

  • tumor lesion(s) on the MRI imagesup to 6 months

    Efficacy will be determined by the response of the tumor lesion(s) compared to baseline. Tumor lesions on the MRI images (units: mm) will be measured every three weeks up to six months.