18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Determination of progression by early PET scan
研究概览
简要总结
The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.
详细描述
Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment of stage III/IV non small cell lung cancer. In order to refine treatments and patients' prognosis, early assessment of tumour response is needed.
The aim of this study is to describe the early tumour metabolic changes in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response.
Eligible patients with stage III/IV, PDL1>50% NSCLC will receive pembrolizumab treatment as per standard of care.
Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3 months.
Prognostic and predictive value of baseline and dynamic metabolic parameters will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Non operable non small cell lung cancer
- •Indication of treatment by Pembrolizumab
- •PD-L1 status superior to 50 %
- •Age more than 18 years
- •At least one measurable target
- •Written inform consent
排除标准
- •no treatment by pembrolizumab
- •immunosuppressive treatment
- •uncontrolled diabete
- •Pregnancy or breast-feeding
- •curatorship or guardianship
- •not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons
结局指标
主要结局
Determination of progression by early PET scan
时间窗: 3 months
Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab
次要结局
- Progression free survival(24 months)
- Overall survival(24 months)