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RECRUITING

NCT07837739

Adjuvant EGFR-TKI Therapy After Surgery for EGFR-Mutant High-Risk Stage IA2-IIB NSCLC

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers. Eligible tumors must harbor an EGFR alteration, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutations. High-risk stage IA2 disease is defined by at least one protocol-specified high-risk feature, including an invasive tumor component greater than 2 cm, lymphovascular invasion, a high-grade histologic pattern (at least 20% solid, micropapillary, cribriform, or complex glandular components), spread through air spaces, or sublobar resection. Postoperative management, including adjuvant EGFR-TKI therapy or observation, is determined by routine clinical practice and patient/physician preference rather than assigned by the study. Participants are categorized by EGFR mutation type into common sensitizing mutations (Group A) and uncommon/resistant mutations (Group B), with clinical stage used for stratified analyses. The primary outcome is disease-free survival (DFS). Secondary outcomes include 2-, 3-, and 5-year DFS rates, overall survival (OS), 5-year OS, health-related quality of life measured using the SF-36, and safety outcomes. Tumor tissue and serial blood samples are collected for genomic and exploratory biomarker analyses.

Official title: A Multicenter Registry Study of Adjuvant EGFR-TKI Therapy Following Curative Resection for EGFR-Mutant High-Risk Stage IA2-IIB Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-07-02

Completion Date

2026-12-31

Last Updated

2026-09-23

Healthy Volunteers

Not specified

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

Adjuvant EGFR-TKI Therapy

Routine-care postoperative EGFR-TKI therapy. First-generation options include gefitinib, erlotinib, and icotinib; third-generation options include furmonertinib, osimertinib, and almonertinib. Maximum planned duration is 3 years.

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.

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China