NCT00333294已完成2 期
A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
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
- 50
- 试验地点
- 4
- 主要终点
- To estimate the objective response rate in patients treated with this drug
研究概览
简要总结
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •18 to 75 years inclusive.
- •At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
- •WHO performance status of 0 to 2 inclusive.
- •Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
- •Life expectancy of at least 6 months.
- •Using secure contraceptives precautions.
排除标准
- •Any previous anti cancer therapy for NSCLC.
- •Known severe hypersensitivity to these products
- •Any evidence of clinically active interstitial lung disease
- •Other co-existing malignancies, symptomatic metastases.
- •Abnormal blood test
- •Weight loss of over 15% in the 3 months before the start of the study.
- •Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
结局指标
主要结局
To estimate the objective response rate in patients treated with this drug
次要结局
- Determine the safety and toxicity of this drug in these patients
研究者
研究点 (4)
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