An Observational Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib in Real-world Clinical Set-tings in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is an observational, non-interventional, single-country, multi center, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC) who had been treated with Afatinib at any line.
详细描述
This is an observational, non-interventional, single-country, multicenter, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic EGFR mutation-positive NSCLC who had been treated with Afatinib s at any line.
The study is carried out by hospital-based oncologists/pneumonologists specializing in lung cancer under real-world conditions of daily clinical practice. Investigators were selected through a documented and structured feasibility process which accounted for physicians' qualifications, previous participation and experience in similar clinical studies, recruitment potential, and retention capability. In addition, in order to represent variations in current real-world patterns of care, research sites were recruited from various geographic regions in Greece, also taking into consideration the regional setting and type of healthcare site/institution (publicly/privately owned, specialized oncology/pulmonology clinic, university clinic).
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
- •>18 years old
- •Patients diagnosed with Non-small cell lung cancer
- •metastatic disease
- •Afatinib treated in any line
- •EGFR mutated
排除标准
- 未提供
结局指标
主要结局
Progression Free Survival
时间窗: From Day 1 of treatment with Afatinib until disease progression, death from any cause or last follow-up, whichever occurs first, up to 12 months
Progression Free Survival
次要结局
- Overall survival(From Day 1 of treatment with Afatinib until death from any cause or last follow-up, up to 24 months)
- Second progression-free survival (PFS2)(From the initiation of next treatment following discontinuation of Afatinib to the date of progression, death or last contact, up to 6 months)
- Assessment of the safety profile of Afatinib(In every cycle, every 28 days)
