Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- [18F]F-AraG uptake signal
研究概览
简要总结
This is a pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.
详细描述
Approximately 50 patients will undergo two research PET/CT scans with [18F]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of [18F]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment [18F]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment [18F]F AraG PET/CT within 7-14 days of treatment.
Objectives:
- Quantify [18F]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy).
- Correlate change in [18F]F AraG uptake in tumor lesions with radiographic response.
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
- •Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease.
- •RECIST measurable disease.
- •ECOG performance status of 0, 1 or
- •Life expectancy >/= 6 months at enrollment.
排除标准
- •Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
- •Pregnant women or nursing mothers.
- •Patients with severe claustrophobia.
结局指标
主要结局
[18F]F-AraG uptake signal
时间窗: two years
\[18F\]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment
次要结局
未报告次要终点