Focused Ultrasound for Brain Mets from Lung Cancer

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

Recruiting Phase 3 Interventional Study
Brain Tumor Non Small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
InSightec · Industry
Who this trial is looking for

This trial is looking for adults with non-small cell lung cancer that has spread to the brain. Participants will receive a focused ultrasound treatment along with standard therapy. To join, patients must be on specific immune therapies and meet certain health guidelines.

Are You a Good Fit for This Trial?
Must be taking Immune checkpoint inhibitors
Rules you out Acute intracranial hemorrhageActive infectionSignificant liver dysfunction

You may be able to join if

  • I am at least 18 years old.
  • I have given my written consent to participate.
  • I am able to follow the study procedures throughout the trial.
  • I have non-small cell lung cancer and am taking an immune checkpoint inhibitor.
  • I have a specific type of brain tumor measuring at least 0.5 cm.
  • I am a woman not planning pregnancy during the study.
  • My performance status is satisfactory, meaning I can care for myself.

You may not be able to join if

  • I have had a recent acute brain bleed.
  • I have signs of high pressure in my brain.
  • I am receiving treatment with Bevacizumab or similar medications.
  • I have an active infection such as Hepatitis B, Hepatitis C, or HIV.
  • I have received an organ transplant.
  • I have severe liver dysfunction or diseases.
  • I have a history of autoimmune disease needing systemic treatment in the last 2 years.
  • I am currently enrolled in another clinical trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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 Locations
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Eligibility Criteria
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…
Contacts

Alyssa Voelker-Christy

817-948-5219

clinicalresearchquestions@insightec.com

CONTACT