A Non-interventional Study and Its Clinical Relevance With Central Nervous System Metastatic Epidermal Growth Factor Receptor Mutation Positive Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.
详细描述
This is a descriptive observational study, in which data are collected in an EGFR mutant NSCLC. Our research plan aims to use multi-omics approaches to predict the likelihood of patients developing brain metastases, assess the prognosis of brain metastasis treatment, and identify potential biomarkers.
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
- •Patients must be ≥18 years.
- •Provision of fully informed consent prior to any study specific procedures.
- •Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together.
- •Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).
- •According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
时间窗: 2 years
Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
次要结局
- Central nervous system (CNS) progression-free survival(2 years)
- Objective Response Rate(2 years)
研究者
Yongchang Zhang
Professor, Deputy Director of Thoracic Oncology Department
Hunan Province Tumor Hospital