Radiation boost may tame brain spread in lung cancer
NCT ID NCT06741085
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with a specific type of lung cancer (EGFR-mutant NSCLC) that has spread to the brain. Researchers want to see if adding a precise, one-time radiation treatment (SRS) to the standard drug osimertinib is better than the drug alone at controlling brain tumors. About 56 participants will be followed for at least 3 months, and their quality of life will be tracked through questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- osimertinib (a targeted oral drug) and stereotactic radiosurgery (SRS, a precise radiation treatment)
- What this could lead to
- If successful, this could show that adding focused radiation to standard drug therapy improves control of brain metastases and quality of life for people with EGFR-mutant lung cancer.
- What could go wrong
- This is a small, early-phase trial (56 participants) and may not prove that the combination is better. Radiation can cause side effects like brain swelling or fatigue, and the benefit may not be large enough to change standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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BAPTIST ALLIANCE - MCI (Data Collection Only)
RECRUITINGMiami, Florida, 33143, United States
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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