Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
研究概览
简要总结
This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.
At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.
详细描述
Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain
研究设计
- 研究类型
- Observational
- 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
- •Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
- •Confirmed EGFR mutation by a validated test
- •Availability of medical record
排除标准
- •Participating on a blinded randomized clinical trial at any time during the study period
- •Pregnant women (due to they do not reflect daily clinical practice)
结局指标
主要结局
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
时间窗: 32 months
次要结局
- Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain.(32 months)
- Evaluation of overall response rate (ORR).(32 months)
- Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate).(32 months)
- Evaluation of overall survival (OS: median OS and 1 year OS rate).(32 months)
- Description of clinical outcome data in all EGFR M+ patients by regimen, type of EGFR TK mutation, line of therapy and other relevant demographics or clinic pathologic characteristics.(32 months)
- Evaluation of disease control rate (DCR).(32 months)