Active — Not RecruitingPhase 2

SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI

China202 participantsStarted 2023-08-10

Plain-language summary

Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pathologically confirmed non-small cell lung cancer; * Clinical stage IV (AJCC, 8th edition, 2017); * EGFR mutations: EGFR L858R, EGFR exon 19 deletion; * Age ≥18 years; * KPS score ≥70; * Brain metastasis at the time of diagnosis; * Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain; * Receiving first-line treatment with third-generation EGFR inhibitors; * After 3-6 months of third-generation EGFR inhibitor treatment, imaging review indicates no progression of extracranial lesions, and brain lesions are evaluated by thin-layer (1mm layer) enhanced MRI, meeting the following criteria: * No more than 10 remaining brain lesions; * The maximum diameter of the remaining brain lesions does not exceed 3cm; * At least one remaining brain lesion has a diameter greater than 5mm; * After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy. * Patient informed consent. Exclusion Criteria: * Poor compliance with the study protocol in the investigator's opinion; * Patients withdrew their informed consent and requested to withdraw from the study; * Patients were unable to receive regular doses of third-generation EGFR inhibitors due to other underlying conditions, viral side effects, economic factors, etc. (e.g., continuous discontinuation for more than 1 week, cumulative discontinuation for more than 2 weeks). * Patients did not follow the protocol for…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival

Timeframe: Two years

Trial details

NCT IDNCT06020066

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-10

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