Analysis of Blood Samples in Small Cell Lung Cancer Patients Treated With Tarlatamab
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Number of blood samples collected to better characterize tarlatamab in real-world setting
研究概览
简要总结
The overall objective of this project is to prospectively collect blood samples throughout treatment with tarlatamab in patients with small cell lung cancer (SCLC). These samples will then be analyzed through a variety of assays to better characterize tarlatamab in the real-world setting.
The investigators will prospectively collect blood samples from 25 patients on days 1, 8, and 15 of tarlatamab treatment, as well as after each interval scan for disease monitoring. The investigators will also collect patient data including demographics and baseline characteristics, primary diagnosis, treatment history, and disease monitoring and progression.
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 documented small cell lung cancer (SCLC) or neuroendocrine tumor
- •Appropriate candidate for treatment with tarlatamab based on investigator discretion
- •Age > 18 years
- •Signed written informed consent including HIPAA according to institutional guidelines
排除标准
- •Does not meet all inclusion criteria
结局指标
主要结局
Number of blood samples collected to better characterize tarlatamab in real-world setting
时间窗: Days 1, 8, and 15 of tarlatamab and after each interval scan for disease assessment
Studies to better understand tarlatamab may include, but are not limited to, the following: 1) predictors of response to treatment with tarlatamab, 2) identification of predictive biomarkers for the development of cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS), 3) characterization of the immune cell environment induced by tarlatamab, 4) identification of resistance mechanisms to tarlatamab treatment, and 5) development of potential translational correlates.
次要结局
未报告次要终点