An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)-REASON STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 589
- 试验地点
- 1
- 主要终点
- Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity
研究概览
简要总结
The primary objective of the study is to collect epidemiological data on EGFR mutation status [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Female or male aged 18 years or above.
- •Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV).
- •Patients receiving 1st-line treatment for IIIB/IV NSCLC.
- •Patients with known EGFR mutation status (i.e. patients must be either EGFR M+, EGFR M- or EGFR Mx).
- •Tumour not amenable to curative surgery or radiotherapy.
排除标准
- •Mixed histology of small cell and non-small cell lung cancer.
结局指标
主要结局
Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity
时间窗: Up to 2,5 years
Clinico-pathological characteristics according to mutation status
时间窗: Up to 2,5 years
次要结局
- Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients(Up to 3,5 years)
- Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients(Up to 2,5 years)
- Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR)(Up to 3,5 years)