Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter registry collects data from adults with completely resected, EGFR-mutant NSCLC (stage IA2 to IIB) to see how postoperative EGFR-TKI therapy compares with observation in routine practice. Eligible patients have specific high-risk features and confirmed EGFR mutations, and treatment decisions are made by clinicians and patients. The study tracks safety and effectiveness of adjuvant EGFR-TKI therapy in a real-world setting across five centers. Enrollment targets about 100 participants aged 18 to 75 years. Outcomes will be analyzed in the context of standard postoperative care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years, male or female, with written informed consent.
* Histologically confirmed primary non-small cell lung cancer, pathologic stage IA2 to IIB; protocol summary further specifies lung adenocarcinoma / predominantly non-squamous histology.
* For stage IA2 disease, at least one protocol-defined high-risk feature: invasive component \>2 cm; lymphovascular invasion; high-grade pattern comprising ≥20% solid, micropapillary, cribriform, or complex glandular components; spread through air spaces (STAS); or sublobar resection (segmentectomy/wedge resection).
* EGFR mutation-positive disease confirmed by the central laboratory, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutation.
* Complete surgical resection with negative margins (R0); lobectomy or sublobar resection may be included according to the protocol.
* No previous antitumor treatment, including no neoadjuvant radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
* ECOG Performance Status 0-1.
* Hematologic criteria: RBC ≥3.0×10\^12/L; WBC ≥3.5×10\^9/L; ANC ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L.
* Renal function: serum creatinine ≤1.2×ULN.
* Hepatic function: total bilirubin ≤1.5×ULN; ALT and AST ≤1.5×ULN.
* Able and willing to comply with protocol-specified treatment/observation and follow-up.
* Adequate tumor tissue available and willingness to provide tissue and blood samples for study analyses.
* Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.

Exclusion Criteria:

* Contraindication to anesthesia or surgery, or death attributable to the surgical procedure before study enrollment/evaluation.
* Any systemic disease incompatible with participation in the clinical study or inability to provide written informed consent.
* Pregnancy or breastfeeding.
* Known active alcohol or drug abuse or dependence.
* Any serious or unstable medical condition or psychiatric disorder that, in the investigator's judgment, would make participation inappropriate.
* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Wei Ping, Dr.
• Email: pingwei@tjh.tjmu.edu.cn
• Phone: 13437101581

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.