Prospective Evaluation of a Proteomic Signature Developed to Identify Patients Likely to Benefit From Erlotinib (TarcevaTM), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Used in the Treatment of Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Value of a recently identified proteomic algorithm
研究概览
简要总结
The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy.
This is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.
详细描述
Screening/Baseline
- Routine blood tests (Haematology and Biochemistry) as per hospital practice
- Research serum sample for proteomic studies (10ml blood sample)
- Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size
2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment
1 year Post Commencement of Treatment with erlotinib (as per current standard of care): Routine CT with RECIST/WHO assessment
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
- •18 years of age or older
- •Any patient who is suited to receive CT scans as part of his/her routine care
- •Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures
- •Planned treatment with erlotinib.
排除标准
- •Patients younger than 18 years of age
- •Patients not foreseen to receive TarcevaTM treatment
结局指标
主要结局
Value of a recently identified proteomic algorithm
时间窗: Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
Routine CT with RECIST/WHO assessment
次要结局
未报告次要终点