A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 主要终点
- Correlation of overall survival with previous treatment regimens
研究概览
简要总结
This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.
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
- •Adult patients, >/= 18 years of age
- •Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
- •Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:
- •squamous cell carcinoma lung cancer histology, and
- •current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva
排除标准
- •Current treatment with an investigational drug or participation in another investigational study
- •Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
- •Clinically active interstitial lung disease
- •Recent myocardial infarction or unstable angina
- •Progressive or uncontrolled brain metastases
结局指标
主要结局
Correlation of overall survival with previous treatment regimens
时间窗: approximately 2 years
Correlation of overall survival with baseline clinical/demographic patient characteristics
时间窗: approximately 2 years
Correlation of overall survival with baseline tumour characteristics
时间窗: approximately 2 years
次要结局
- Safety: Incidence of adverse events(approximately 2 years)
- Objective response rate (ORR), tumour assessments according to RECIST criteria(approximately 2 years)
- Disease control rate(approximately 2 years)
- Progression-free survival(approximately 2 years)