NCT05317858 · InSightec
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
(LIMITLESS)
What this study is about
The purpose of this study is to evaluate the safety and effectiveness 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.
View original scientific description
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.
Interventions
DEVICE
Blood Brain Barrier Opening - Oncology
BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
DRUG
Pembrolizumab
Pembrolizumab infusion
DRUG
Atezolizumab
Atezolizumab infusion
DRUG
Cemiplimab
Cemiplimab infusion
DRUG
Nivolumab
Nivolumab infusion
DRUG
Iptilimumab
Iptilimumab infusion
Primary outcome measures
Adverse events
Time frame: up 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 images
Time frame: up 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 dur
Where
- Phoenix, Arizona
- Newport Beach, California
- Miami, Florida
- Tampa, Florida
- Baltimore, Maryland
- Winston-Salem, North Carolina
- Portland, Oregon
- Providence, Rhode Island
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations