Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 54
- 主要终点
- Progression free survival
研究概览
简要总结
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.
Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.
Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •2nd or 3rd line of non squamous non small cell lung cancer of stage III or IV
- •Document progression at the time of the inclusion. At least, one previous chemotherapy line with platinum. Patient who had previous treatment with bevacizumab can be included.
- •Patient with active mutation of EGFR must have had on line of chemotherapy with platinum and one with Tyrosine kinase inhibitor of EGFR.
- •Patient with ALK rearrangement must have had at least one line of chemotherapy with platinum and one with crizotinib.
排除标准
- •Mixed cancer small cells and non small cells or squamous lung cancer.
- •Central nervous system symptomatic metastasis or requiring immediate cerebral radiotherapy
- •patient who have had previous treatment with taxane (docetaxel, paclitaxel). Peri-operatory chemotherapy or chemoradiotherapy with taxane allowed if stopped more than 6 months before.
研究组 & 干预措施
Docetaxel
干预措施: Docetaxel (Drug)
Paclitaxel - Bevacizumab
干预措施: Paclitaxel (Drug)
Paclitaxel - Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression free survival
时间窗: about 4 months
Time between inclusion and progression
次要结局
- Response Rate(At 8 weeks)
- Overall survival(about 8 months)