NCT00264498已完成2 期
A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2
适应症
干预措施
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
- 38
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Non Small cell Lung Cell Lung cancer
- •Never received chemotherapy
- •Up and about 50% of waking hours
排除标准
- •Spread of lung cancer to the brain
- •Low level of white blood cells
- •Radiotherapy within 4 weeks
- •Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.
研究组 & 干预措施
1
Active Comparator
Gemcitabine + Carboplatin
干预措施: Gemcitabine (Drug)
1
Active Comparator
Gemcitabine + Carboplatin
干预措施: Carboplatin (Drug)
2
Experimental
Gefitinib
干预措施: Gefitinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Date of randomization to earliest date of objective disease progression
Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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