EUCTR2011-002224-40-ES进行中（未招募）不适用
A randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of MetMAb in Combination with Tarceva® (erlotinib) in Patients with Met Diagnostic-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Standard Chemotherapy for Advanced or Metastatic Disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
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 consent
- •? Male or female, 18 years of age or older
- •? ECOG performance status of 0?1
- •? Stage IIIb/IV NSCLC
- •? Tumor sample to be centrally tested for Met and EGFR (tumor results must be Met diagnostic-positive)
- •? Prior treatment with at least one platinum-based line of treatment (in metastatic stage) and no more than one additional line of chemotherapy treatment
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •? More than 30 days with an EGFR inhibitor (such as gefitinib, erlotinib, cetuximab)
- •? Brain metastasis or spinal cord compression unless treated and stable
- •? Another malignancy in the past 3 years
- •? Life expectancy less than 12 weeks
- •? Abnormal granulocytes, platelets, hemoglobin
- •? Abnormal serum AST (SGOT), ALT (SGPT), alkaline phosphatase (ALP), bilirubin, albumin, calcium, creatinine
- •? Significant history of cardiac disease
- •? Serious active infection or other serious medical conditions
- •? Inflammatory eye changes
- •? Clinically significant gastrointestinal abnormalities
- •? Unable to take oral medication, need for intravenous feeding, poor absorption, or active peptic ulcer disease
- •? Symptomatic hypercalcemia requiring bisphosphonate therapy
- •? Patients known to be HIV positive
- •? Recent major surgery
- •? Pregnant or lactating women
- •? Women of childbearing potential or sexually active males who are not employing adequate contraception (or practicing complete abstinence)
研究者
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