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Treating brain metastasis in lung cancer with radiosurgery and osimertinib

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

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT06741085

This study is testing if adding a special type of radiation therapy to the lung cancer drug osimertinib can help people with brain metastases feel better and improve their treatment results.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment56 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsradiation, osimertinib
Locations8 sites (Miami, Florida and 7 other locations)
Trial IDNCT06741085 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of combining stereotactic radiosurgery (SRS) with osimertinib, a targeted therapy for non-small cell lung cancer (NSCLC) with EGFR mutations, in patients who have brain metastases. Participants will receive standard systemic therapy with osimertinib for three months before being randomized to either continue with osimertinib alone or add SRS. The study aims to assess not only the clinical outcomes but also the impact on patients' quality of life through questionnaires. The goal is to determine if the addition of SRS improves treatment outcomes compared to osimertinib alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-small cell lung cancer and a confirmed EGFR mutation who have at least one measurable brain metastasis.

Not a fit: Patients with prior brain-directed radiotherapy or those with leptomeningeal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with lung cancer that has spread to the brain.

How similar studies have performed: Previous studies have shown promising results with similar approaches combining targeted therapies and radiosurgery, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Participant Inclusion Criteria: Screening

* Age ≥ 18 years
* Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution
* At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter requirement)
* Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start)

Participant Exclusion Criteria: Screening

* Unable to undergo contrast-enhanced MRI brain
* Prior brain-directed radiotherapy
* Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated.
* Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS
* Active hematologic malignancy or a second solid tumor histology with known CNS tropism
* Patients who have undergone a therapeutic craniotomy for resection of one or more symptomatic brain metastasis are ineligible unless one or more additional intact BM remain unresected, and meets size criteria (e.g., a patient with removal of a 3cm symptomatic brain metastasis, but has an additional visible lesion remaining post-operatively, remains eligible for the study).
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
* Pregnant women or women who are breastfeeding or of childbearing potential. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 3 months after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)

Participant Inclusion Criteria: Randomization

\- Presence of detectable and non-progressing BM lesions on imaging consistent with viable residual disease

Participant Exclusion Criteria: Randomization

* Progressive Disease (PD) with multiple lesions and/or other features that would warrant a change in systemic therapy, as determined by the primary treating provider
* Presence of BM not deemed safely treatable with SRS, as determined by a radiation oncologist
* Intracranial Complete Response (CR)
* More than 20 visible residual brain metastases at the time of enrollment (i.e. after initial treatment with TKI). However, no upper limit on the number of visible brain metastases is set at the time of initial diagnosis prior to treatment with TKI. For example, a patient who had 35 visible brain metastases at the time of diagnosis, but after three months of treatment with TKI had 10 visible brain metastases remaining will be eligible for enrollment and randomization

Where this trial is running

Miami, Florida and 7 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Small Cell Lung Cancer Metastaticsomatic activating mutation in EGFRconsolidative stereotactic radiosurgerytyrosine-kinase inhibitor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.