Pilot Study to Identify the Mechanism of De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors (EGFR-TKIs) in NSCLC With EGFR Mutation.
试验速览
- 阶段
- 不适用
- 入组人数
- 155
- 主要终点
- hazard rates of PFS
研究概览
简要总结
This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.
详细描述
Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven unresectable NSCLC
- •20 years of age or older
- •Planned treatment with Iressa®
- •Patients with activating EGFR mutation (del 19, L858R)
- •Available detailed smoking history
- •Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
- •Available blood sample
- •At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
- •Written informed consent
排除标准
- •More than 3rd line treatment
- •Previously treated with other EGFR-TKI
- •Life expectancy of less than 12 weeks
- •Pregnant or lactating female
- •Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
- •Unsuitable patient in this treatment as determined by doctor.
结局指标
主要结局
hazard rates of PFS
时间窗: 1year
The primary objective is to compare hazard rates of PFS in patients treated with Iressa between with and without any molecular aberrancy in EGFR-downstream genes/proteins.
次要结局
未报告次要终点
研究者
Joo Hang Kim
Severance Hospital
Severance Hospital