NCT00256711已完成2 期
A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 192
- 试验地点
- 55
- 主要终点
- To compare ZD1839 and vinorelbine in terms of progression free survival
研究概览
简要总结
This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue
- •NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks
- •WHO Performance status <= 2
排除标准
- •Newly diagnosed CNS metastases
- •Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity.
- •Hypersensitivity to ZD1839 or intravenous vinorelbine
- •Prior treatment with EGFR inhibitors
- •Other co-existing malignancies
- •ALT/AST >2.5 x ULRR
- •ANC < 2.0 x 10^9/L or platelets < 100 x 10^9/L
结局指标
主要结局
To compare ZD1839 and vinorelbine in terms of progression free survival
次要结局
- To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
- To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
- To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
- To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
- To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
研究者
研究点 (55)
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