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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedosimertinib and stereotactic radiosurgery (SRS)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 17, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Interventions being studied: Drug: osimertinib; Radiation: stereotactic radiosurgery (SRS)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Targeted therapy→Radiation therapy→Surgery→

Study topics

Brain metastases→Survivorship and quality of life→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Participant 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

BAPTIST ALLIANCE - MCI (Data Collection Only)Miami, Florida
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New Jersey
Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Commack, New York
Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York
Memorial Sloan Kettering Nassau (All Protocol Activities)Rockville Centre, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 17, 2026. Always confirm current availability with the study team.

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