EUCTR2004-002536-26-IE进行中（未招募）不适用
Open, non-randomized phase II pilot study of neoadjuvant cetuximab in combination with cisplatin and gemcitabine, to evaluate their efficacy, safety and biological pharmacodynamic effects in patients with resectable stage IB-IIIA non small cell lung cancer (NSCLC) - ERbitux - phase II
Dr Ken O'Byrne0 个研究点目标入组 50 人开始时间: 2004年9月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed written informed consents·
- •Male or female >=18 years of age·
- •Diagnosis of histologically confirmed NSCLC, stage IB IIIA disease·
- •Presence of unidimensionally measurable disease using RECIST criteria.
- •Life expectancy of >= 3 months.
- •Performance status 0-1.
- •Effective contraception for both male and female patients if risk of conception exists.
- •Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 9 g/dL.
- •Bilirubin level <1.5 x ULN.
- •ASAT and ALAT <= 3 x ULN.
- •Creatinine clearance >= 60 ml/min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Proven or symptomatic brain metastases·
- •Stage IIIB or IV disease.
- •Major surgery within 4 weeks prior to study entry.
- •Chest irradiation within 4 weeks prior to study entry.
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol.
- •Any prior chemotherapy for the current disease or within 5 years of the current diagnosis.
- •Any investigational agent(s) within 4 weeks prior to entry.
- •Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy.
- •Known drug abuse·
- •Pregnancy (absence confirmed by serum/urine b-HCG) or breast-feeding.
- •Legal incapacity or limited legal capacity.
研究者
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