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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

osimertinib. A third-generation, orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor, with potential antineoplastic activity. Upon oral administration, osimertinib covalently binds to and inhibits the activity of numerous mutant forms of EGFR, including the secondarily-acquired resistance mutation T790M, L858R, and exon 19 deletions, thereby preventing EGFR-mediated signaling. This may both induce cell death and inhibit tumor growth in EGFR-overexpressing tumor cells. EGFR, a receptor tyrosine kinase mutated in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization. As this agent is selective towards mutant forms of EGFR, its toxicity profile may be reduced when compared to non-selective EGFR inhibitors which also inhibit wild-type EGFR. NCI Drug Dictionary

Treatments listed in the registry

• osimertinib (Drug): oral EGFR-TKI
• stereotactic radiosurgery (SRS) (Radiation): 0-20mm-18Gy x 1, 21Gy x 1 ,9Gy x 3 20mm or larger- 9Gy x 3, 6Gy x 5, 5Gy x 5

Randomized · Parallel · masking: None

Main goals

• intracranial progression-free survival (iPFS) (3 months)

Other goals

• Time to CNS progression

Planned enrollment: 56 (estimated).

• 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

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06741085
• NCI Drug Dictionary: C116377

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 27, 2026. Public record; not medical advice.