NCT02988141Unknown不适用
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC
Jianxing He0 个研究点目标入组 100 人开始时间: 2017年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- The biomarker profile of EGFR-TKI resistance
研究概览
简要总结
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC
详细描述
Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 prior to any study specific procedures.
- •Male or female patients aged 18 years and older.
- •Histological confirmation of stage IIIB/IV NSCLC.
- •Documented EGFR mutation positive .
- •WHO Performance Status 0, 1 or 2
排除标准
- •Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
- •Previous (within 6 months) or current treatment with AZD9291.
结局指标
主要结局
The biomarker profile of EGFR-TKI resistance
时间窗: Baseline
次要结局
- The concordance, sensitivity and specificity in paired blood and tissue samples(Baseline)
研究者
Jianxing He
Principle Investigator
The First Affiliated Hospital of Guangzhou Medical University
相似试验
Unknown
不适用
Efficacy Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary AdenocarcinomaCancerNCT01745302Shanghai University of Traditional Chinese Medicine470
Unknown
不适用
A Retrospective EGFR Mutation Status Study in Chinese NSCLC Patients Using Paired Plasma and Tissue SamplesCarcinoma, Non-Small-Cell LungNCT01382992Peking Union Medical College Hospital150
Unknown
不适用
Study on the Therapeutic Effect of TCM Treatment for MDR MNIdiopathic Membranous NephropathyNCT02610595Shanghai University of Traditional Chinese Medicine220
已完成
2 期
Re-challenge of Anti-EGFR for Patients With RAS/BRAF Wild-type Metastatic CRCMetastatic Colorectal CancerNCT04224415Yuhong Li35
已完成
不适用
EGFR-TKI versus chemotherapy for Asians with previously untreated advanced non-small cell lung cancer: a meta-analysisJPRN-UMIN000028424Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University, Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan1,000