Adjuvant EGFR-TKI Therapy After Surgery for EGFR-Mutant High-Risk Stage IA2-IIB NSCLC
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Adjuvant EGFR-TKI Therapy
DrugRoutine-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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Common Sensitizing EGFR Mutation Cohort1 intervention
Group B: Uncommon/Resistant EGFR Mutation Cohort1 intervention
Trial outcomes
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.
Time frame
From surgery until disease recurrence or death, assessed up to 3 yearsSecondary 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 months3
5-Year Disease-Free Survival Rate
Time frame
5 years after surgery4
5-Year Overall Survival Rate
Time frame
5 years after surgerySponsors and contacts
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Source ClinicalTrials.gov