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

NCT07837739 | Recruiting DMC

• 1 other identifier: TJ-IRB202506003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS)

  Time from the date of surgery to investigator-confirmed disease recurrence or death from any cause, whichever occurs first.

  From surgery until disease recurrence or death, assessed up to 3 years

Secondary Outcomes (6)

• 2-Year Disease-Free Survival Rate

  2 years after surgery.

• Overall Survival (OS)

  From date of enrollment until the date of death from any cause, assessed up to 60 months

• 5-Year Disease-Free Survival Rate

  5 years after surgery

• 5-Year Overall Survival Rate

  5 years after surgery

• Incidence and Severity of Adverse Events

  Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, and every 12 weeks thereafter until date of death from any cause, assessed up to 60 months

Study Arms (2)

Common Sensitizing EGFR Mutation Cohort

Participants with common sensitizing EGFR mutations, including exon 19 deletion and L858R, following complete surgical resection of high-risk stage IA2-IIB NSCLC.

Drug: Adjuvant EGFR-TKI Therapy

Uncommon/Resistant EGFR Mutation Cohort

Participants with uncommon or resistant EGFR mutations, including exon 20 insertion and PACC mutations, following complete surgical resection of high-risk stage IA2-IIB NSCLC.

Drug: Adjuvant EGFR-TKI Therapy

Interventions

Adjuvant EGFR-TKI Therapy DRUG

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.

Common Sensitizing EGFR Mutation Cohort; Uncommon/Resistant EGFR Mutation Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with EGFR-mutant, completely resected high-risk stage IA2 to stage IIB NSCLC/lung adenocarcinoma who are treated and followed at participating thoracic oncology centers in Hubei Province, China.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wei Ping, Dr.

CONTACT

13437101581; pingwei@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 23, 2026
• Study Start: July 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)