Randomized, Controlled Study Comparing the Efficacy and Safety of Docetaxel （60mg/m2）Maintenance Treatment vs. Best Supportive Care Following First Line Chemotherapy With Different Doses of Docetaxel（75/60mg/m2）in Combination With Cisplatin in Patients With Local Advanced or Metastatic （Stage IIIB/IV）Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) during the maintenance treatment phase
研究概览
简要总结
The Primary Objective is to evaluate the progression-free survival (PFS).
The secondary objectives are:
- To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria;
- To evaluate the overall response rate (ORR);
- To evaluate the time to disease progression (TTP);
- To evaluate the overall survival (OS);
- To evaluate the toxicity.
详细描述
The study consists in:
- A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) ,
- A maintenance treatment phase: participants with disease control (complete response [CR], partial response [PR] or stable disease [SD]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC).
- A follow-up period from the end of study treatment until participant death or end of study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
干预措施: Docetaxel (Drug)
First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
干预措施: Cisplatin (Drug)
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
干预措施: Docetaxel (Drug)
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
干预措施: Cisplatin (Drug)
Maintenance treatment: docetaxel (60 mg/m2)
Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
干预措施: Docetaxel (Drug)
Maintenance treatment: best supportive care (BSC)
BSC until progressive disease
干预措施: Best supportive care (BSC) (Other)
结局指标
主要结局
Progression-free survival (PFS) during the maintenance treatment phase
时间窗: From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
次要结局
- Time to disease progression (TTP) during the maintenance treatment phase(From 2nd randomization up to disease progression (every 2 cycles (6 weeks)))
- Disease control rate (DCR) during the first line treatment phase(Every 2 cycles (6 weeks))
- Overall response rate (ORR) during the first line treatment phase(Every 2 cycles (6 weeks))
- Overall survival (OS)(From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period))