NCT01769066已完成2 期
Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- 12 weeks of non-progression rate
研究概览
简要总结
The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
详细描述
Patients will be randomized to 2 groups
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
- •18~70 years
- •Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
- •Presence of at least one index lesion measurable by CT scan or MRI
- •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
- •AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
- •Signed written informed consent
排除标准
- •Patients have 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
研究组 & 干预措施
Sequential Gefitinib With Pemetrexed/Platinum
Experimental
Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16
干预措施: Sequential Gefitinib With Pemetrexed/Platinum (Drug)
Pemetrexed/Platinum
Active Comparator
Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1
干预措施: Pemetrexed/Platinum (Drug)
结局指标
主要结局
12 weeks of non-progression rate
时间窗: from the first cycle of treatment (day one) to two month after the last cycle
次要结局
- PFS(from the first cycle of treatment (day one) to two month after the last cycle)
研究者
Chang Jian Hua
Deputy director of department of medical oncology
Fudan University
研究点 (1)
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