Avoiding Radiation for Brain Metastases with Systemic Therapy

This study is looking at whether some patients with brain metastases (cancer that has spread to the brain) can avoid radiation therapy if their tumors respond well to other treatments like chemotherapy, targeted therapy, or immunotherapy. It will include 45 adults, mostly those with non-small cell lung cancer (NSCLC) and some with other solid tumors. You would receive your usual systemic therapy, and doctors would monitor your brain metastases with MRI scans. If your tumors are stable or shrinking, you might not need radiation. The main goal is to see how many NSCLC patients can avoid radiation for at least 6 months, especially depending on their PD-L1 status (a protein on cancer cells).

Study design
This is a pilot study with 45 participants, divided into two groups based on their cancer type. It is an interventional study, meaning participants will receive a specific treatment plan.
What's involved
You would undergo brain MRI scans every 3 months after starting systemic therapy. Radiation therapy would only be given if your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 6 months from your baseline brain MRI.

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NCT06974370

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Vermont Medical Center
~45 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Active Surveillance

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-Month Radiation Therapy-Free Survival (RTFS) by PD-L1 Status in NSCLC Patients with Brain Metastases
Measured over 6 months from baseline brain MRI
Brain Metastases, Adult
Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
1 sites across 1 states
Vermont1
  • Randall Holcombe, MD, MBA · STUDY_DIRECTOR · University of Vermont Cancer Center

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Eligibility criteria

Inclusion

Brain penetrant targeted therapies (e.g. tyrosine kinase inhibitors, multikinase inhibitors, EGFR inhibitor, ALK inhibitor, BRAF/MEK inhibitor)
Checkpoint inhibitor immunotherapy (e.g. PDL-1 inhibitors, PD1 inhibitors, CTLA-4 inhibitors)
HER2 antibody-drug conjugate (e.g. TDM1, TDX-D)
Anti-Hormone therapies for Breast Cancer
Cytotoxic chemotherapy alone may be started initially, but with plan for immunotherapy or eligible targeted therapy noted above before the re-evaluation MRI head
  • 6-Month Radiation Therapy-Free Survival (RTFS) by PD-L1 Status in NSCLC Patients with Brain Metastases6 months from baseline brain MRI

    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