NCT00259064已完成2 期
A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
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
- 216
- 试验地点
- 1
- 主要终点
- To compare Iressa v best supportive care in terms of progression free survival
研究概览
简要总结
The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed NSCLC
- •NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- •Not suitable for chemotherapy
- •WHO Performance status 2 or 3
排除标准
- •Newly diagnosed CNS mets
- •Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
- •Other co-existing malignancies
- •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
研究组 & 干预措施
Gefitinib
Experimental
ZD1839 + BSC (best supportive care)
干预措施: Gefitinib (Drug)
Placebo
Placebo Comparator
Placebo + BSC (best supportive care)
干预措施: Placebo (Other)
结局指标
主要结局
To compare Iressa v best supportive care in terms of progression free survival
时间窗: Progression-free survival
次要结局
- To compare Iressa v best supportive care in terms of objective tumour response rate(Overall objective tumour response rate (CR and PR) according to the RECIST criteria)
- To compare Iressa v best supportive care in terms of overall survival(Time to death)
- To compare Iressa v best supportive care in terms of quality of life(Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score)
- To compare Iressa v best supportive care in terms of tolerability(Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs)
研究者
研究点 (1)
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