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Radiation boost may tame brain spread in lung cancer

NCT ID NCT06741085

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • BAPTIST ALLIANCE - MCI (Data Collection Only)

    RECRUITING

    Miami, Florida, 33143, United States

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    RECRUITING

    Rockville Centre, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    RECRUITING

    Harrison, New York, 10604, United States

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