Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year.
研究概览
简要总结
This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years at time of diagnosis
- •Affiliation to a social insurance
- •Obtaining the patient's non opposition
- •Patients with non-small cell lung carcinoma, confirmed by anatomopathological, metastatic or locally advanced unresectable, not eligible for local curative treatment
- •Cellular or tissue FFPE available
- •Indication of treatment with pembrolizumab + first line chemotherapy in multidisciplinary consultation meeting
- •No mutation of the EGFR gene, no rearrangement of ALK and ROS,
- •At least one measurable tumor according to RECIST criteria
排除标准
- •Tissue or cellular FFPE not available
- •Systemic anti-neoplastic or immunotherapy previously received except neoadjuvant or adjuvant treatment completed 6 months or more
结局指标
主要结局
The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year.
时间窗: At 1 year
Progression will be evaluated by CT imaging every 12 weeks and then every 9 weeks according to RECIST 1.1. The independent variables will be the 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) evaluated prior to the first injection of pembrolizumab + chemotherapy from the diagnostic tissue material.
次要结局
- Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test.(At 1 year)