A Non Interventional Trial of Tarceva Metastatic Non Small Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 主要终点
- Progression-free Survival (PFS) Time
研究概览
简要总结
This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It is the physician's decision to prescribe erlotinib in participants and to document their treatment
- •Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label
排除标准
- •Participants will be excluded if safety concerns occurred
- •If the participant was not compliant or if the participant would wish to stop erlotinib therapy
研究组 & 干预措施
Erlotinib
Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Time
时间窗: Up to 6 years
Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.
Percentage of Participants With Best Overall Response
时间窗: Up to 6 years
Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\] 10 millimeter \[mm\]). No new lesions. PR was defined as greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.
次要结局
- Overall Survival (OS) Time(Up to 6 years)