Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- the evolution of ctDNA mutation profile during treatment
研究概览
简要总结
To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.
详细描述
In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of the patients had a progressive disease (PD) in their targeted lesion.
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
- •Provision of informed consent
- •Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
- •No EGFR mutation in tissue and ctDNA
- •Received immune checkpoint inhibitors as the first line therapy
- •ECOG performance status 0-2 with expected more than 6 months of survival time
- •Willingness to comply with required protocols and give permission to use the data for clinical research and products development
排除标准
- •Patients have other primary cancers
- •Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
- •Patients failed in either plasma or tissue sample QC
研究组 & 干预措施
Immune checkpoint inhibitors
干预措施: Observation (Other)
Targeted therapy
Targeting ALK, ROS1, MET ex14 skipping
干预措施: Observation (Other)
结局指标
主要结局
the evolution of ctDNA mutation profile during treatment
时间窗: every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
次要结局
- Resistant mechanisms of targeted therapy(At the time of disease progression (through study completion, an average of 1.5 years))