Actively Recruiting
Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics (ICON-RT)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-13
56
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding stereotactic radiosurgery (SRS) to treatment with osimertinib improves outcomes for people with non-small cell lung cancer (NSCLC) that has spread to the brain. The study aims to compare brain metastasis control between those receiving osimertinib alone and those receiving osimertinib plus SRS. The impact on participants' quality of life will also be evaluated using questionnaires. Participants will receive standard systemic therapy with osimertinib, an FDA-approved drug targeting specific mutations in the EGFR gene. One group will receive osimertinib alone, while the other will receive osimertinib plus SRS radiation treatment directed at brain metastases after three months of osimertinib therapy. Radiation doses vary based on tumor size and are delivered in specific fractions. During the study, participants will undergo brain MRI scans to monitor brain metastases and complete quality of life questionnaires. Researchers will measure intracranial progression-free survival and time to central nervous system progression. The study is randomized without masking, and participants will be followed over time to assess treatment effects and safety, with total study duration extending through 2027.
CONDITIONS
Brief Title
A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of non-small cell lung cancer with an activating EGFR mutation confirmed at the enrolling center
- At least one intact brain metastasis visible on contrast MRI before starting targeted therapy
- Either no prior targeted therapy or started targeted therapy within 3 months with documented start date and imaging
- Detectable, non-progressing brain metastases suitable for study enrollment
You will not qualify if you...
- Unable to undergo contrast-enhanced brain MRI
- Previous brain-directed radiotherapy
- Evidence of leptomeningeal disease on spine MRI or lumbar puncture
- Neurologic symptoms or brain lesions requiring immediate stereotactic radiosurgery
- Active blood cancer or second solid tumor with known brain spread
- Prior therapeutic brain surgery unless additional untreated brain metastases remain
- Unlikely to comply with study procedures
- Pregnant, breastfeeding, or women of childbearing potential not using effective contraception
- Progressive disease requiring change in systemic therapy
- Brain metastases not safely treatable with stereotactic radiosurgery
- Complete intracranial response (no visible brain metastases)
- More than 20 visible brain metastases after initial targeted therapy treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive standard systemic therapy with osimertinib. Some participants also receive stereotactic radiosurgery (SRS) to treat brain metastases depending on their assigned group.
Visits occur regularly during treatment as per protocol
Duration - Up to 9 months
Participants are monitored for intracranial progression and other outcomes after treatment ends.
Periodic visits for assessments
Trial Site Locations
Total: 8 locations
1
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States, 33143
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
L
Luke Pike, MD
H
Helena Yu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here