NCT01790217已完成不适用
GERMAN TARCEVA NON-INTERVENTIONAL STUDY in 1st Line Treatment of NSCLC EGFR Mutation Positive Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Progression-free survival rate at 18 months
研究概览
简要总结
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients, >/= 18 years of age
- •Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer
- •Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines
排除标准
- 未提供
结局指标
主要结局
Progression-free survival rate at 18 months
时间窗: 3.5 years
次要结局
- Response rate (complete response/partial response) by type of mutation(3.5 years)
- Percentage of patients with remission(3.5 years)
- Progression-free survival (overall/stratified)(3.5 years)
- Overall survival (overall/stratified)(3.5 years)
- Tolerability: Incidence of fatigue, rash, diarrhea(3.5 years)
- Safety: Incidence of serious adverse events(3.5 years)
- Dose modifications/withdrawals(3.5 years)
- Symptom control (cough, dyspnea)(3.5 years)
研究者
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