Multicenter Prospective and Retrospective Cohort Study in Non-small Cell Lung Cancer Patients with EGFR Mutation: Korean EGFR Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,001
- 试验地点
- 39
- 主要终点
- Clinical characteristics of NSCLC patients with EGFR mutation
研究概览
简要总结
Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR mutation to collect and analyze the patient's clinical features, diagnosis, and treatment results.
详细描述
The Korean EGFR Registry is a prospective multicenter observational cohort study designed to enroll all stage EGFR-mutated non-small cell lung cancer (NSCLC) patients. However, due to the extended follow-up period required to confirm clinical outcomes, a retrospective cohort has been included. This retrospective cohort comprises patients with recurrent or metastatic NSCLC who began taking EGFR TKI after January 2021. The recruitment phase was planned to span 36 months, commencing in May 2022, with scheduled follow-up activities continuing until December 2026. The target enrollment for this study is set at 2,000 patients, with competitive enrollment to be carried out across 40 university hospitals in Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 20-year-old with Korean nationality
- •A person who voluntarily signed the informed consent form for this study
- •All stage Non small cell lung cancer patients with EGFR mutation or Metastatic or recurred EGFR mutated NSCLC patients started with EGFR TKI treatment from 2021-01-01.
排除标准
- •A person who is not confirmed NSCLC histologically or cytologically.
- •A person who doesn't consent to the study.
- •A person who is unable to complete the study judged by the investigator.
结局指标
主要结局
Clinical characteristics of NSCLC patients with EGFR mutation
时间窗: 12months, 18months, 24months, 36months
Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
PFS
时间窗: 12months, 18months, 24months, 36months
PFS underwent palliative therapy according to stages in NSCLC patients with EGFR mutation
Clinical outcome of NSCLS patients with EGFR mutation
时间窗: 12months, 18months, 24months, 36months
Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
DFS
时间窗: 12months, 18months, 24months, 36months
DFS in patients underwent definitive therapy according to stages in NSCLC patients with EGFR mutation
次要结局
- DoR (duration of response)(up to 36months)
- TTF (time to treatment failure)(up to 36months)
- Analysis of metastatic sites and treatment patterns (especially brain and bone metastasis)(up to 36months)
- ORR(overall response rate)(up to 36months)
- OS(Overall survival)(up to 36months)
- Adverse event profiles(up to 36months)
- Diagnosis Test Method(up to 36months)
- DCR (disease control rate)(up to 36months)
- TTNF (time to next treatment)(up to 36months)