NCT01366131已完成2 期
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
研究概览
简要总结
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.
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
- •Histologically or cytologically documented inoperable (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC that are based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type.
- •ECOG performance status of 0 or 1
- •Life expectancy >12 weeks
- •Measurable disease, as defined by RECIST 1.1
- •Adequate hematologic and end organ function
排除标准
- •Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC. Patients who received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded if the time interval from completion of adjuvant therapy until disease progression is > 12 months.
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
- •Pregnant and lactating women
- •Active infection requiring IV antibiotics
- •Bevacizumab-Specific Exclusions:
- •Histologically or cytologically documented inoperable, locally advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- •Evidence of tumor invading major blood vessels on imaging
- •Evidence of central nervous system (CNS) metastases
- •History of stroke or transient ischemic attacks (TIAs) within 6 months prior to Day 1
- •Significant vascular disease within 6 months prior to Day 1
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1
研究组 & 干预措施
A
Experimental
干预措施: MEGF0444A (Drug)
A
Experimental
干预措施: bevacizumab (Drug)
A
Experimental
干预措施: carboplatin (Drug)
A
Experimental
干预措施: paclitaxel (Drug)
B
Experimental
干预措施: bevacizumab (Drug)
B
Experimental
干预措施: carboplatin (Drug)
B
Experimental
干预措施: paclitaxel (Drug)
B
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
时间窗: Up to 24 months
次要结局
- Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study)(Up to 24 months)
- Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1(Up to 24 months)
- Overall survival (defined as the time from randomization until death from any cause)(Up to 24 months)
研究者
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