Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 932
- 试验地点
- 89
- 主要终点
- Overall survival
研究概览
简要总结
In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.
There is two types of maintenance strategies:
- Continuous maintenance : prolongation of the treatment initially associated with platin until progression
- Switch maintenance : introduction of a new treatment after the end of induction chemotherapy
The aim of this study is to compare two maintenance strategies
- A continuous maintenance by pemetrexed
- A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-squamous NSCLC histologically or cytologically confirmed
- •Stage IV with a cytologically or histologically confirmation for an unique metastasis
- •No EGFR activating mutation or indeterminate EGFR mutational status
- •At least one measurable lesion
- •Age between 18 and 70
- •PS 0 or 1
排除标准
- •squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer
- •Knowledge of ALK gene rearrangement
- •Symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy
- •Superior venous cave syndrome except if treated by implantation of a prosthesis
- •Previous anti-tumoral treatment
- •Concomitant radiotherapy
研究组 & 干预措施
Continuous maintenance Therapy
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
干预措施: Pemetrexed (Drug)
Continuous maintenance Therapy
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
干预措施: Cisplatin (Drug)
Maintenance according to the response of induction
Induction chemotherapy by cisplatin + gemcitabine followed by :
- continuous maintenance therapy by gemcitabine if response disease
- switch maintenance therapy by pemetrexed if stable disease
干预措施: Pemetrexed (Drug)
Maintenance according to the response of induction
Induction chemotherapy by cisplatin + gemcitabine followed by :
- continuous maintenance therapy by gemcitabine if response disease
- switch maintenance therapy by pemetrexed if stable disease
干预措施: Cisplatin (Drug)
Maintenance according to the response of induction
Induction chemotherapy by cisplatin + gemcitabine followed by :
- continuous maintenance therapy by gemcitabine if response disease
- switch maintenance therapy by pemetrexed if stable disease
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall survival
时间窗: around 20 months
次要结局
- Safety analysis(Around 5 months)
- Disease free survival(Around 5 months)
- Control and response rate(After 4 cycles)
- treatment exposure(Around 5 months)