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NCT Number: NCT07837739

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Wei Ping

CONTACT

[email protected]

13437101581

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Disease-Free Survival (DFS)

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

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

Secondary outcomes

  1. 2-Year Disease-Free Survival Rate

    Time frame: 2 years after surgery.

  2. Overall Survival (OS)

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

  3. 5-Year Disease-Free Survival Rate

    Time frame: 5 years after surgery

  4. 5-Year Overall Survival Rate

    Time frame: 5 years after surgery

  5. Incidence and Severity of Adverse Events

    Time frame: 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

  6. Change in SF-36 Health-Related Quality of Life Scores

    Time frame: Baseline, after 2 weeks of treatment, after 4 weeks of treatment, after 12 weeks of treatment, every 12 weeks during the first 3 years, and every 6 months thereafter until date of death from any cause, assessed up to 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Ping, Dr.

CONTACT

[email protected]

13437101581

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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