NCT00275132已完成3 期
A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.
Secondary
- Compare progression-free survival and response rate.
- Compare toxicity.
- Compare the quality of life.
- Compare cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erlotinib
Experimental
Tarceva (OSI-774, erlotinib) PO 150mg daily
干预措施: erlotinib hydrochloride (Drug)
Matched placebo
Placebo Comparator
Matched placebo PO daily
干预措施: Matched placebo (Drug)
结局指标
主要结局
Overall survival
时间窗: between date of randomisation and date of death from any cause
次要结局
- Progression free survival(from the date of randomisation to the date of first clinical evidence of progressive disease, or death.)
- Adverse events/Toxicity(during and for 28 days following Tarceva/placebo treatment)
- Quality of life(between randomisation and 8 weeks.)
- Cost-effectiveness(from date of randomisation to death)
研究者
研究点 (1)
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