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NCT06974370 · ClinicalTrials.gov registry record · Phase 2
Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial
A Phase 2 study, sponsored by University of Vermont Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT06974370: Recruiting Phase 2 study, sponsored by University of Vermont Medical Center.
NCT06974370 is a Phase 2 study that is actively recruiting participants, run by University of Vermont Medical Center. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06974370, a Phase 2 study, is actively recruiting participants, sponsored by University of Vermont Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and/or chemotherapy. The study will prospectively enroll 45 patients, divided into two cohorts: 30 with non-small cell lung cancer (NSCLC) receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible participants must have at least one brain metastasis not planned for radiation or surgery and must be initiating or planning to initiate a systemic therapy regimen expected to penetrate the blood-brain barrier and achieve intracranial activity. All patients will undergo a re-evaluation brain MRI 4-8 weeks after initiating systemic therapy. If lesions are stable or regressing, patients will continue surveillance without radiation. If progression is noted, standard-of-care radiation may be administered at the discretion of the treating physician. The primary objective is to assess 6-month radiation therapy-free survival (RTFS) in NSCLC patients based on PD-L1 expression status. Secondary endpoints include intracranial progression-free survival, overall survival, radiation necrosis rate, and quality of life. This study seeks to inform future trial design and identify patients who may safely avoid brain radiation.
Primary Outcome
To determine variability in 6-month RT-free survival (RTFS) in Non-Small Cell Lung Carcinoma (NSCLC) patients with brain metastases depending on PDL-1 status receiving systemic therapy including immunotherapy
Interventions
- RADIATION Active Surveillance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2030-12 |
| Phase | Phase 2 |
What NCT06974370 shows while recruiting
NCT06974370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Active Surveillance is the first listed.
NCT06974370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06974370 about?
NCT06974370 is a clinical study titled "Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial". This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and/or chemotherapy. The study will prospectively enroll 45 patients, divided i...
What is the current status of trial NCT06974370?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2025-06-05. Estimated completion is 2030-12.
What interventions are being tested in trial NCT06974370?
The interventions under investigation include: Active Surveillance (RADIATION).
Who is sponsoring clinical trial NCT06974370?
This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06974370's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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