NCT00234468终止3 期
A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 490
- 试验地点
- 32
- 主要终点
- Time to progression (2 years after Last patient in)
研究概览
简要总结
The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy
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
- •Histologically Confirmed Non Small Cell Lung Cancer.
- •Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
- •Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
- •Response to combined therapy
排除标准
- •No previous treatment with ZD1839 or any other EGFR-targeted therapy
- •No progressive disease after combined therapy for locally advanced NSCLC
- •No presence of metastatic disease
- •No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any unresolved chronic toxicity from previous anticancer therapy.
结局指标
主要结局
Time to progression (2 years after Last patient in)
次要结局
- Modalities of relapse or progression (2 years after Last patient in)
- Overall survival (2 years after Last patient in)
研究者
研究点 (32)
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