Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 28
- 主要终点
- Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)
研究概览
简要总结
Observational, multicentre, retrospective study on patients taken care according to the national guidelines. The objective is to define, after the diagnosis confirmation, the frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients aged > or = 18 years
- •Diagnosis of Large-cell NEC confirmed by centralised reading
- •Tumoral materials available and readable for PD-L1 labeling
排除标准
- •Other type of Lung cancers
- •Tumoral material not available or not readable for centralised reading
- •Tumoral material not available or not readable for PD-L1 labeling
结局指标
主要结局
Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)
时间窗: Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis: The frequency of PD-L1 expression determined by IHC will be as follow: * Negative PD-L1 tumours (\<1% of positive tumour cells) * Positive PD-L1 tumours (\> or = to 1% of positive tumour cells) * Low positive PD-L1 tumours (from 1% to 49% of positive tumour cells expressed) * High positive PD-L1 tumours (\> or = 50% of positive tumour cells expressed)
次要结局
- Correlation of PD-L1 expression of tumour cells with clinical data(Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016)
- Objective Response Rate (ORR)(Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016)
- Progression-free survival (PFS)(Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016)
- Overall survival (OS)(Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016)