NCT01192243Unknown2 期
Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
- •Age from 18 to 70 years old
- •At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
- •Expected life time longer than 12 weeks
- •Normal laboratory values:
- •leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis)
排除标准
- •Patients have not used drugs according to protocol
- •Patients were allergic to pemetrexed or cisplatin
- •Patients received radiotherapy or other biological treatment 4 weeks before the trial
- •Uncontrolled hydrothorax or hydropericardium
- •neuropathy toxicity ≥ CTC 3
- •Severe symptomatic heart disease
- •Active upper gastrointestinal ulcer or digestive disfunction
- •Severe infection or metabolic disfunction
- •Patients with other malignant tumor
- •Uncontrolled brain metastases
- •Patients have accepted other clinical trials
- •Female patients during their pregnant and lactation period, or patients without contraception
结局指标
主要结局
response rate
时间窗: six weeks
次要结局
- Number of Participants with Adverse Events(six weeks)
- Progression free survival(six weeks)
- quality of life(six weeks)
研究者
研究点 (1)
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