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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Adjuvant EGFR-TKI Therapy (Drug)
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.
干预措施: Adjuvant EGFR-TKI Therapy (Drug)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: 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.
次要结局
- 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)
- Change in SF-36 Health-Related Quality of Life Scores(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)