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NCT05317858 · ClinicalTrials.gov registry record · Phase 3
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
A Phase 3 study of Non-Small Cell Lung Cancer and Brain Tumor, sponsored by InSightec.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 8
- Study locations
NCT05317858: Recruiting Phase 3 study of Non-Small Cell Lung Cancer and Brain Tumor, sponsored by InSightec.
NCT05317858 is a Phase 3 study of Non-Small Cell Lung Cancer and Brain Tumor that is actively recruiting participants, run by InSightec. The registered enrollment target is 30 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05317858, a Phase 3 study of Non-Small Cell Lung Cancer and Brain Tumor, is actively recruiting participants, sponsored by InSightec.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cemiplimab
- DRUG Atezolizumab
- DRUG Nivolumab
- DEVICE Blood Brain Barrier Opening - Oncology
Study Locations (8)
Florida
- Miami Cancer Institute at Baptist Health - Miami
- Moffitt Cancer Center - Tampa
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Maryland
- University of Maryland - Baltimore
Rhode Island
- Rhode Island Hospital - Providence
Virginia
- Johnston Willis Hospital - Richmond
Ontario
- Sunnybrook Research Institute - Toronto
Seoul
- Samsung Medical Center - Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-08-12 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 3 |
What NCT05317858 shows while recruiting
NCT05317858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05317858 lists 8 locations in 7 states (Florida, Arizona, Maryland).
Frequently Asked Questions
What is clinical trial NCT05317858 about?
NCT05317858 is a clinical study titled "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 inhibi...
What is the current status of trial NCT05317858?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2022-08-12. Estimated completion is 2027-12-01.
What conditions does trial NCT05317858 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Brain Tumor.
What interventions are being tested in trial NCT05317858?
The interventions under investigation include: Pembrolizumab (DRUG), Cemiplimab (DRUG), Atezolizumab (DRUG), Nivolumab (DRUG), Blood Brain Barrier Opening - Oncology (DEVICE).
Who is sponsoring clinical trial NCT05317858?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05317858 being conducted?
This trial has 8 study locations across Arizona, Florida, Maryland, Rhode Island, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05317858's enrollment target sits among peer trials
30 387th of 454 higher than 58 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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