NCT01887886已完成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 Mutation
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Progression-free survival (investigator-assessed according to RECIST v1.1)
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient, >/= 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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Prior exposure to agents targeting either the Hepatocyte Growth Factor (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 >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.
- •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
研究组 & 干预措施
Onartuzumab + Erlotinib
Experimental
干预措施: erlotinib (Drug)
Onartuzumab + Erlotinib
Experimental
干预措施: onartuzumab (Drug)
Placebo + Erlotinib
Active Comparator
干预措施: erlotinib (Drug)
Placebo + Erlotinib
Active Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free survival (investigator-assessed according to RECIST v1.1)
时间窗: approximately 3 years
次要结局
- Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms(approximately 3 years)
- Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires(approximately 3 years)
- Overall survival(approximately 3 years)
- Pharmacokinetics: Area under the concentration-time curve (AUC)(Day 1 Cycles 1, 2 and 4)
- Overall response rate(approximately 3 years)
- Safety: Incidence of adverse events(approximately 3 years)
研究者
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