NCT03877250撤回不适用
Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC
研究概览
简要总结
The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein.
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
- •Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 >/= 50%)
- •Intended treatment with a PD-(L)1 inhibitor
- •Age >/= 18 years
- •Karnofsky Performance Status >/= 70% and medically fit to undergo a biopsy procedure
排除标准
- •Any medical condition or any sites of disease that would preclude a biopsy
- •Pregnant or breastfeeding women
- •Cognitively impairment affecting ability to understand and provide informed consent
- •Prior PD-(L)1 blockade treatment
- •Chemotherapy within 6 months prior to enrollment
结局指标
主要结局
Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (6)
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