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Stereotactic Radiosurgery and Osimertinib for Lung Cancer Spread to the Brain

This study is looking at people with non-small cell lung cancer (NSCLC) that has spread to the brain. Researchers want to see if adding stereotactic radiosurgery (SRS), a type of radiation therapy, after 3 months of treatment with osimertinib (an oral drug) is better than just using osimertinib alone. You could join if you are 18 or older, have NSCLC with a specific gene change called an EGFR mutation, and have at least one brain tumor. The study will measure how long it takes for brain tumors to grow or spread (intracranial progression-free survival) at 3 months. Researchers will also check how the treatments affect your quality of life using questionnaires. The current status of this study is unclear, and it plans to enroll 56 people.

Study design
This is an interventional study with an unclear phase, planning to enroll 56 participants. It compares two treatment approaches for brain metastases in NSCLC.
What's involved
Patients in both groups will receive osimertinib. One group will also receive stereotactic radiosurgery (SRS).
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, intracranial progression-free survival, is measured at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06741085

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~56 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:osimertinibstereotactic radiosurgery (SRS)

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
intracranial progression-free survival (iPFS)
Measured over 3 months

Conditions

Non Small Cell Lung Cancer Metastatic

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Where it's being run

8 sites across 3 states
New York4
New Jersey3
Florida1

Study leadership

  • Luke Pike, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Luke Pike, MD
[email protected]
212-639-8157
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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)
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

What this trial measures

  • intracranial progression-free survival (iPFS)3 months

    Intracranial progression will be assessed at 3-month intervals and is defined as a ≥20% increase in sum longest distance relative to nadir for target lesions (up to a max of 5 lesions; must include at least one lesion increased in size by an absolute value of 5mm), unequivocal progression of non-target lesions, and/or the presence of new lesions, as defined by the RANO-BM working group criteria