Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 14
- 主要终点
- The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
研究概览
简要总结
To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.
详细描述
In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all 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 80 Years（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 non-smoking 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
- •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
结局指标
主要结局
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
时间窗: 2 years
次要结局
- The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.(1 year)