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2004年9月15日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Dr Ken O'Byrne
- 入组人数
- 50
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
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.
结局指标
主要结局
未指定
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