A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 945
- 试验地点
- 23
- 主要终点
- Proportion of Enrolled Participants Submitting Sufficient Blood Samples
研究概览
简要总结
The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Documented diagnosis of mNSCLC or ES-SCLC
- •Planned initiation of SOC systemic anti-cancer treatment
- •Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563
排除标准
- •Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
研究组 & 干预措施
All-Comer Cohort
Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
干预措施: Blood Draw (Other)
Front-line Immunotherapy Re-enrollment Cohort
Participants with mNSCLC or ES-SCLC that have received front-line treatment as defined by the protocol will give blood samples at three separate timepoints for ctDNA profiling.
干预措施: Blood Draw (Other)
结局指标
主要结局
Proportion of Enrolled Participants Submitting Sufficient Blood Samples
时间窗: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.
Proportion of Potential Eligible Participant Enrollment
时间窗: Up to 5 years
次要结局
- Blood Level of ctDNA(At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.)