RecruitingNot Applicable

The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer

China60 participantsStarted 2025-12-02

Plain-language summary

This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.

Who can participate

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

. Informed consent signed;
. Age ≥ 18 years;
. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
. Recurrence after/on Osimertinib treatment according to RECIST 1.1;
. NGS gene test report (tumor or blood sample) at the time of recurrence;
. Receiving or not receiving neoadjuvant treatment before surgery.

Exclusion criteria

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

Recurrence gene profiles

Timeframe: From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records.

Trial details

NCT IDNCT06477055

SponsorHunan Province Tumor Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-31

Contact for this trial

Yongchang Zhang, MD

13873123436 zhangyongchang@csu.edu.cn

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials

Who can participate

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

. Informed consent signed;
. Age ≥ 18 years;
. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
. Recurrence after/on Osimertinib treatment according to RECIST 1.1;
. NGS gene test report (tumor or blood sample) at the time of recurrence;
. Receiving or not receiving neoadjuvant treatment before surgery.