NCT01523340已完成不适用
Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The rates of C-met expression/amplification and EGFR gene mutations
研究概览
简要总结
- Trial design: Prospective observational study
- Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
- Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
- C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
- We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
- Duration of Trial Recruitment: 2 years
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •19~80 year old male or female
- •Histologically proven advanced or metastatic NSCLC
- •Failed to 1st line chemotherapy
- •Tumor tissue for genetic analysis
- •Evaluable target lesion by RECIST v1.1
- •ECOG performance from 0 to 3
- •Expected survival more than 12 weeks
排除标准
- •Previous treatment of EGFR-tyrosine kinase inhibitors
- •Severe hypersensitivity to erlotinib
- •Residual toxicities (above grade 2) after previous chemotherapy
- •Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits
结局指标
主要结局
The rates of C-met expression/amplification and EGFR gene mutations
时间窗: Average of 1 year
To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib : C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
次要结局
未报告次要终点
研究者
Young-Chul Kim
Professor
Chonnam National University Hospital
研究点 (1)
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