EUCTR2011-002224-40-NL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 Onartuzumab (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
- 490
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 prior to any study-specific screening procedure
- •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 for locally advanced, unresectable/inoperable disease or metastatic disease, 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 245
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 245
排除标准
- •More than 30 days with an EGFR inhibitor (such as gefitinib, erlotinib, cetuximab)
- •Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
- •Brain metastasis or spinal cord compression unless treated and stable
- •Another malignancy in the past 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
- •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 with uncontrolled diabetes mellitus, as evidenced by fasting serum glucose level > 200 mg/dL
- •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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已完成
3 期
A randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (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 DiseaseIncurable lung cancerNon-Small Cellular Long Cancer10038666NL-OMON39593Roche Registration Ltd.10
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