The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 Years and older
- •Advanced non-squamous non-small cell lung cancer; AND
- •Patients who have received more than 4 cycles of pemetrexed therapy before the study
排除标准
- •Interstitial pneumonia; AND
- •Abnormal blood test
研究组 & 干预措施
pemetrexed with bevacizumab
pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1)
干预措施: pemetrexed with bevacizumab (Drug)
结局指标
主要结局
progression free survival
时间窗: Within the study period and until tumor proression, an expected average of 16 weeks
次要结局
- Number of Participants with Adverse Events(From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years)
- response rate(The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks)
- time to treatment failure (TTF)(From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
- overall survival(From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years)
研究者
Daichi Fujimoto
doctor, division of respiratory medicine
Kobe City General Hospital