CompletedNot Applicable

Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC

China4,000 participantsStarted 2018-09-01

Plain-language summary

The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance. In summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC.

Who can participate

Age range

18 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 sensitizing mutations (L858R or 19del); * age≥18 years old; * KPS score≥70; * complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment; * received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy); * willing to cooperate with the follow-up after third-generation EGFR-TKI treatment; * informed consent of the patient. Exclusion Criteria: * Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years); * Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI; * Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.; * patients without EGFR sensitive mutations or with unknown EGFR mutation status. Withdrawal criteria * The investigators considered that the patients had poor adherence to the study protocol. * The patient withdrew informed consent and asked to withdraw. * There was any safety reason (adverse event) considered by the investigator; * Due to other underlying diseases, side effects, economic factors, and other reasons, patients did not receive reg…

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

Time to Best Response

Timeframe: 5 years

Trial details

NCT IDNCT06613633

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-01

View on ClinicalTrials.gov More Third-generation TKI trials