Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Mean change in B regulatory cells (Bregs)
研究概览
简要总结
This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •≥ 18 years old at the time of informed consent
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Subjects with histologically and radiographically confirmed NSCLC.
- •Subjects must have stage IV disease or recurrent disease.
- •Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible.
- •Subjects who are eligible to receive single agent immunotherapy must have documentation of a PD-L1 Tumor Proportion Score (TPS) of at least 1%.
- •Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
排除标准
- •Subjects with curable or potentially curable NSCLC.
- •Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria.
- •Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy.
- •Subjects eligible for combination treatment with chemoimmunotherapy.
结局指标
主要结局
Mean change in B regulatory cells (Bregs)
时间窗: baseline and cycle 3
change in Bregs before and after treatment
Mean change in T regulatory cells (Tregs) before and after treatment
时间窗: baseline and cycle 3
change in Tregs before and after treatment
Mean change in myeloid derived suppressive cells (MDSCs)
时间窗: baseline and cycle 3
change in MDSCs before and after treatment
次要结局
- Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs(baseline, cycle 3)
- Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs(baseline, cycle 3)
研究者
Nasser Hanna
Professor of Medicine, Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research
Indiana University