Multicenter, Retrospective, Observational Study of Icotinib for Post-Surgical Adjuvant Therapy in Stage IA2 High-Risk to IB Non-Small-Cell Lung Cancer With Positive EGFR-Sensitive Mutations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,572
- 试验地点
- 2
- 主要终点
- Overall survival period（OS）
研究概览
简要总结
This is a multicenter, retrospective, observational real-world study designed based on real-world data. Eligible medical institutions that meet standardized data quality requirements and have an adequate sample size will be enrolled in this study. The treatment group consists of patients with completely resected (R0) stage IA2 high-risk to IB non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who received adjuvant icotinib therapy after radical resection. The control group includes patients with completely resected (R0) stage IA2 high-risk to IB NSCLC with positive EGFR-sensitizing mutations who received routine observational follow-up after surgery. Propensity score-matched analyses will be conducted between the treatment and control groups to evaluate the efficacy and safety of adjuvant icotinib therapy in this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Histologically confirmed primary non small cell lung cancer (NSCLC), predominantly non squamous histology (including adenocarcinoma or mixed carcinoma with a major adenocarcinoma component)
- •2. Pathologically confirmed stage IA2 high risk to IB NSCLC following complete surgical resection (R0) of primary lung cancer. Disease staging follows the 8th edition of the AJCC/UICC lung cancer staging system.
- •3. Post surgical tumour tissue specimens test positive for EGFR sensitizing mutations using an approved assay
- •4. Patients in the control group received postoperative observation without any anti tumour therapy prior to disease recurrence or metastasis.
排除标准
- •1. A history of other malignancies within 5 years prior to lung cancer surgery, with the exception of curatively treated malignancies.
- •2.Prior receipt of systemic anti-tumor therapy for NSCLC within 6 months before lung cancer surgery or before disease recurrence and metastasis.
研究组 & 干预措施
Routine Observational Group
Patients with completely resected (R0) stage IA2 high-risk to IB NSCLC with positive EGFR-sensitizing mutations who received routine observational follow-up after surgery.
干预措施: Routine Observational (Other)
Icotinib Group
Patients with completely resected (R0) stage IA2 high-risk to IB non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who received adjuvant icotinib therapy after radical resection.
干预措施: Icotinib (Drug)
结局指标
主要结局
Overall survival period（OS）
时间窗: Data collection deadline (This study is a retrospective study and there is no predetermined evaluation time).The index date for this study is defined as 4 weeks following complete surgical resection (R0).
次要结局
未报告次要终点