Search / Trial NCT06613633

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

Launched by FUDAN UNIVERSITY · Sep 23, 2024

Trial Information

Current as of December 22, 2024

Completed

Keywords

Nsclc Egfr

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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 regular doses of third-generation EGFR-TKI (continuous withdrawal time more than 1 week, cumulative withdrawal time more than 2 weeks, etc.).
  • The patient was not followed up according to the protocol.
  • Other circumstances in which withdrawal from the study was deemed necessary by the investigator.

About Fudan University

Fudan University, a prestigious comprehensive research university located in Shanghai, China, is committed to advancing medical science through innovative clinical research. Renowned for its rigorous academic standards and cutting-edge research facilities, Fudan University plays a pivotal role in the global health landscape by sponsoring a diverse array of clinical trials aimed at improving patient outcomes and addressing pressing medical challenges. Leveraging its multidisciplinary expertise and collaborative networks, the university strives to translate scientific discoveries into practical applications, fostering advancements in healthcare and contributing to the well-being of communities both locally and internationally.

Locations

Shanghai, Shanghai, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0