NCT01066195Unknown3 期
A Phase III, Multi-center, Randomized Trial of Pemetrexed and Gefitinib in Never-smoker and Adenocarcinoma Patients With Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female.
The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
- •Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
- •Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
- •Never smoker (less than 100 cigarette for the life time)
- •18 year or older
- •No history of biologic or immunotherapy
- •Tolerable renal function ( creatine clearance rate is 60ml/min or more)
- •Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)
排除标准
- •symptomatic brain metastasis
- •previously treated with EGFR tyrosine kinase inhibitor
- •previously treated with antifolate agents
- •poor oral absorption
- •patients with active infection
- •uncontrolled diabetes mellitus
- •significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure)
- •pregnant or nursing patients
- •history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma
研究组 & 干预措施
pemetrexed
Active Comparator
干预措施: alimta (Drug)
gefitinib
Experimental
干预措施: iressa (Drug)
结局指标
主要结局
progression-free survival
时间窗: 36 months
次要结局
- objective response rate(36 months)
- toxicity(36 months)
- overall survival(36 months)
研究者
研究点 (1)
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