NCT01066884已完成4 期
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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;
- •inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
- •ECOG performance status of 0-3;
- •previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.
排除标准
- •prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
- •unstable systemic disease;
- •any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
- •any significant ophthalmologic abnormality.
研究组 & 干预措施
1
Experimental
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Length of patient on study (length of time of patient on study determined by investigator)
次要结局
- Best Response Rate per investigator assessment(Length of patient on study (length of time of patient on study determined by investigator))
- Overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first)
- Time to Progression (TTP)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first)
研究者
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