A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 33
- 主要终点
- Objective response and Progression free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced 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
- •Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
- •Age 18 years or older
排除标准
- •Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer
- •Received radiation therapy within 4 weeks before randomization
- •Major surgery within 4 weeks before randomization
- •Minor surgery within 2 weeks before randomizaiton
- •Systemic steroids within 1 week before randomization
- •Any grade 2 or greater neuropathy
- •History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide)
- •History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
- •Known brain or spinal cord metastases
- •History of other cancers within 5 years before randomization
- •Known HIV, hepatitis-B or hepatitis-C infection
- •Pregnant or breast-feeding women
- •Previously treated with Mapatumumab
研究组 & 干预措施
B
Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
干预措施: Mapatumumab (Biological)
A
Paclitaxel and carboplatin
干预措施: Paclitaxel (Drug)
A
Paclitaxel and carboplatin
干预措施: Carboplatin (Drug)
B
Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
干预措施: Paclitaxel (Drug)
B
Paclitaxel, carboplatin and Mapatumumab 10 mg/kg
干预措施: Carboplatin (Drug)
C
Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
干预措施: Mapatumumab (Biological)
C
Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
干预措施: Paclitaxel (Drug)
C
Paclitaxel, carboplatin and Mapatumumab 30 mg/kg
干预措施: Carboplatin (Drug)
结局指标
主要结局
Objective response and Progression free survival
时间窗: 6 cycles, or until disease progression or unacceptable toxicity develops
次要结局
- Disease control; Overall survival; Response duration and time to response in responders; Frequency and severity of treatment-emergent adverse events; Laboratory parameters; and Serum mapatumumab concentrations for use in a PK analysis.(6 cycles, or until disease progression or unacceptable toxicity develops)