NL-OMON39593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 Disease - OAM4971g
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 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
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
研究者
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