RecruitingPhase 2NCT06741085

A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain

ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

56 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding stereotactic radiosurgery (SRS — a highly precise form of radiation that targets individual brain tumors) to a targeted oral therapy (a tyrosine kinase inhibitor, or TKI) improves outcomes for people with EGFR-mutated non-small cell lung cancer that has spread to the brain. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-small cell lung cancer with a confirmed EGFR mutation - You have at least one brain metastasis visible on MRI - You are either TKI-naïve or started TKI therapy no more than 3 months ago - You are able to undergo an MRI with contrast **You may NOT be eligible if...** - You cannot undergo a contrast-enhanced MRI brain scan - You have previously received radiation therapy to the brain - You started TKI therapy more than 3 months ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGosimertinib

oral EGFR-TKI

RADIATIONstereotactic radiosurgery (SRS)

0-20mm-18Gy x 1, 21Gy x 1 ,9Gy x 3 20mm or larger- 9Gy x 3, 6Gy x 5, 5Gy x 5


Locations(8)

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06741085


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