Early Response Evaluation With 18F-FDG PET/CT and Immunological Profiling of Circulating Immune Cells and Tumor-draining Lymph Nodes in Non-small Cell Lung Cancer Patients Treated With Immunotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
研究概览
简要总结
A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FNA of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor FDG uptake and to identify changes in the immune effector cell subsets in TDLNs. Blood will be drawn in parallel to compare the distribution of immune effector cell subsets before and after treatment initiation. Because of the possible burden for patients, the EBUS-FNA is not mandatory to complete the study and is there for an exploratory objective. Also blood will be drawn for a tumor mutational burden at baseline. The first six patients will undergo a dynamic PET-CT scan in addition to a static scan to study the influence of possible immunotherapy induced changes to the body distribution and kinetics of FDG..
详细描述
Early response evaluation with 18F-FDG PET/CT and immunological profiling of circulating immune cells and tumor-draining lymph nodes in non-small cell lung cancer patients treated with immunotherapy.
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
- 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
- •willing and able to provide written informed consent for the study.
- •≥ 18 years of age on day of signing informed consent.
- •confirmed diagnosis of NSCLC.
- •Histological tumor biopsy for PD-L1 IHC assessment (DAKO assay) available.
- •Ipsilateral hilar or mediastinal lymph node with a short axis diameter ≥1 cm.
- •Eligible and planned to receive nivolumab according to EMA label and national guidelines.
- •Measurable disease according to RECIST v1.
- •WHO performance status of 0-2.
排除标准
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to baseline PET-scan.
- •Has an active infection or had an active infection within 2 weeks prior to baseline PET-scan.
- •Has a known history of hypersensitivity to contrast material.
- •Isolated distant relapse after curative intent treatment for stage I-III NSCLC.
研究组 & 干预措施
Nivolumab
Nivolumab treatment according to label: 3 mg/kg nivolumab IV Q2W, 240mg Q2W or 480mg Q4W as an IV infusion until disease progression or unacceptable toxicity.
FDG PET-CT will be performed at baseline and between 7 and 14 days after treatment initiation
干预措施: 18F-FDG PET-CT (Diagnostic Test)
结局指标
主要结局
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
时间窗: Baseline and at the end of cycle 1 (each cycle is 14 days).
The change in the percentages of selected immune cell parameters (CD4+ T, CD8+ T cells) after immunotherapy treatment as compared to baseline will be calculated
FDG PET-CT analysis
时间窗: Baseline and at the end of cycle 1 (each cycle is 14 days).
Parameter change (SUVpeak) between both scans will be measured.
Peripheral blood mononuclear cells will be isolated and counted using FACS
时间窗: Baseline and at the end of cycle 1 (each cycle is 14 days).
PBMC's will be counted at two timepoints. Change between both timepoints will be assessed.
次要结局
未报告次要终点