NCT01723878已完成不适用
Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 43
- 主要终点
- Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
研究概览
简要总结
This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.
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 locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria
- •EGFR mutation-positive disease according to local laboratory testing
- •Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice
排除标准
- •Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva
- •Participation in another clinical study
- •Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment
结局指标
主要结局
Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
时间窗: 3 years
次要结局
- Objective response rate, tumor assessments according to RECIST v1.1 criteria(3 years)
- One-year overall survival (from initiation of treatment to 12 months after disease progression)(3 years)
- Treatments used after disease progression in clinical practice(3 years)
- Time to progression(3 years)
- Exposure (dosage/duration) with first-line Tarceva in clinical practice(3 years)
- Safety: Incidence of adverse events(3 years)
- Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression(3 years)
研究者
研究点 (43)
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