NCT00242801已完成3 期
A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,692
- 试验地点
- 206
- 主要终点
- The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
研究概览
简要总结
This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.
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
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
- •· Life expectancy of at least 8 weeks.
- •Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
- •Not suitable for chemotherapy
- •WHO Performance status 0,1, 2 or 3
排除标准
- •Newly diagnosed CNS mets
- •Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- •ALT/AST greater than 5 x upper limit of normal
- •ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
结局指标
主要结局
The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
次要结局
- · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
- · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
- · objective tumour response (CR + PR)
- · ZD1839 + BSC versus Placebo + BSC in terms of tolerability
- · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes
研究者
研究点 (206)
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