NCT06849518招募中不适用
Study of Longitudinal Plasma PD-L1 Testing With Immunotherapy in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.
研究概览
简要总结
This is a prospective pilot study to assess dynamic changes of plasma cell-free RNA (cfRNA) PD-L1 expression in patients with lung cancer undergoing immune checkpoint inhibitor (ICI) based therapy. Results will be correlated with radiographic assessment of immunotherapy treatment response and plasma NGS ctDNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a diagnosis of stage IV or inoperable stage IIIB NSCLC without planned primary radiation therapy undergoing anti-PD-1/L1 based ICI treatment.
- •Chemo-immune or dual anti-PD-1/L1 with anti-CTLA-4 based regimens are eligible as long as receiving an anti-PD-1/L1 monoclonal antibody.
- •A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive.
排除标准
- •No anti-PD-1/L1 monoclonal antibody treatment.
- •Planned primary radiation therapy.
- •Small-cell lung cancer histology.
结局指标
主要结局
Correlation of plasma cfRNA PD-L1 by qPCR expression* with ICI treatment and response.
时间窗: up to 24 months
Circulogene ImmunoClear Assay
次要结局
- Correlation of plasma cfRNA PD-L1 expression* results with any available tissue PD-L1 protein expression.(up to 24 months)
研究者
研究点 (2)
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