NCT01659970已完成不适用
A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 主要终点
- Progression-free survival
研究概览
简要总结
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 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
- •Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
- •Patients for whom the treating physician has decided to initiate treatment with Tarceva
排除标准
- •Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
- •Current participation in a clinical trial evaluating an anticancer treatment
结局指标
主要结局
Progression-free survival
时间窗: 2 years
次要结局
- Clinical/demographic patients characteristics at baseline(2 years)
- Treatment schedules: Dose/duration/modifications/interruptions(2 years)
- Overall survival(2 years)
- Safety: Incidence of adverse events(2 years)
- Quality of life: FACT-L version 4 questionnaire(2 years)
研究者
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