A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 40
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (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
- None
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
- •Adults over 18 years of age with a life expectancy of at least 3 months.
- •Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- •Adequate hematologic, renal and hepatic function.
- •PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.
排除标准
- •Squamous cell, small cell, or mixed histology.
- •Known history of bleeding diathesis or coagulopathy.
- •Cavitary tumors or tumors abutting large blood vessels.
- •Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
- •Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
- •Ongoing therapy with oral or parenteral anticoagulants.
- •Concurrent estrogens, anti-estrogens or progesterone compounds.
- •Grade 2 or higher peripheral neuropathy.
- •Radiotherapy within 2 weeks preceding Study Day
- •Symptomatic or clinically active brain metastases.
- •Major surgery within 4 weeks of Study Day
- •Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
- •Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
研究组 & 干预措施
paclitaxel/carboplatin plus bavituximab
Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.
干预措施: Paclitaxel / Carboplatin (Drug)
paclitaxel/carboplatin plus bavituximab
Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.
干预措施: bavituximab (Drug)
paclitaxel/carboplatin
Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
干预措施: Paclitaxel / Carboplatin (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Until disease progression
次要结局
未报告次要终点