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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05317858
The ClinicalTrials.gov registry entry for NCT05317858 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The listed sponsor is InSightec, which has 38 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 7 distinct geographic areas - top geographies include 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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