Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 116
- 试验地点
- 24
- 主要终点
- Efficacy- overall response rate (CR & PR) according to the RECIST criteria
研究概览
简要总结
Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.
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
- •Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
- •Patients must have measurable disease according to the RECIST criteria.
排除标准
- •Prior treatment with chemotherapy; patients may have received prior radiotherapy.
- •Patients with suspected or known CNS metastases.
研究组 & 干预措施
1
Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
干预措施: CPG 7909 (Drug)
1
Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
干预措施: Chemotherapy (Drug)
2
Chemotherapy (a taxane and a platinum compound)
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Efficacy- overall response rate (CR & PR) according to the RECIST criteria
时间窗: Indeterminate
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
时间窗: Indeterminate
次要结局
- Secondary Efficacy(Indeterminate)
- compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups(Indeterminate)
- duration of overall response (CR, PR), survival time, and time to disease progression.(Indeterminate)
- To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination.(Indeterminate)