Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 382
- 试验地点
- 44
- 主要终点
- Progression Free Survival
研究概览
简要总结
Primary objective:
· Progression free survival.
Secondary objectives:
- Assess Overall survival of both treatment groups.
- Assess Tumor response rate using RECIST criteria
- Assess Toxicity profile of patients enrolled in the study.
- Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.
详细描述
Study population:
Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria).
Duration of treatment:
Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator.
Calendar and planned finalization date:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A: Control
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
干预措施: Cisplatin, Docetaxel (Drug)
B1: Experimental group B1
Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
干预措施: Gemcitabine, Cisplatin (Drug)
B2: Experimental group B2
Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
干预措施: Docetaxel, Cisplatin (Drug)
B3: Experimental group B3
Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.
Defined as the length of time from the start of treatment to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Overall Survival(From the date of start of the treatment until death or end of follow up, up to 18 months.)