JPRN-jRCT2080222323未知3 期
A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB IN COMBINATION WITH ERLOTINIB AS FIRST-LINE TREATMENT FOR PATIENTS WITH MET-POSITIVE UNRESECTABLE STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER (NSCLC) CARRYING AN ACTIVATING EGFR MUTATIO
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 300
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Adult patients, >/= 18 years of age
- •- Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- •- No prior treatment for unresectable Stage IIIB or IV NSCLC
- •- Measurable radiographic evidence of disease according to RECIST v1.1
- •- ECOG performance status of 0 or 1
排除标准
- •- Prior exposure to agents targeting either the HGF or MET pathway
- •- Exposure to an investigational or marketed agent that can act by EGFR inhibition
- •- Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
- •- Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/= 14 days
- •- History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
- •- Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
- •- Inadequate hematologic, biochemical, and organ function
- •- Pregnant or lactating women
- •- Life expectancy of < 12 weeks
- •- Receipt of an investigational drug within 28 days prior to initiation of study treatment
研究者
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