cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.
详细描述
Multicenter study aiming to collect patient's clinical data retrospectively and their histological samples prospectively.
The cohort will include:
- 30 patients PD-L1 > 50% treated with pembrolizumab in first line and having a progression free survival ≥ 3 months
- 30 patients PD-L1 > 50% treated with pembrolizumab in first line and having a progression free survival < 3 months
- 30 patients PD-L1 < 50% treated with cisplatin-based chemotherapy in first line
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
- •NSCLC diagnosis
- •Advanced disease (Stage III-IV) according to the TNM 7th/8th classification
- •Patients have to have performed pembrolizumab in first line if PD-L1 ≥ 50% or cisplastin-based chemotherapy if PD-L1 < 50%
- •FFPE material available from diagnostic sample
排除标准
- 未提供
结局指标
主要结局
Progression free survival (PFS)
时间窗: 1 year
To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response
次要结局
- Overall response rate (ORR)(1 year)
- Time to treatment failure (TTF)(1 year)