First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,610
- 主要终点
- Overall survival
研究概览
简要总结
This observational study was planned, with the primary objective to observe patient survival following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) with different platinum-based doublets under routine disease management conditions. Further secondary objectives of this study are to provide insights to what extent histologic subtyping and the use of additional prognostic or predictive biomarkers are currently considered for differential therapeutic decisions under routine conditions. All of these data are critical to evaluate the factors for differential therapeutic decisions and their effect on patient outcomes in a real life setting, and they can only be obtained through observational research.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) stage IIIB-IV
- •Initiation of first-line treatment for advanced NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents
- •18 years of age or older
排除标准
- •Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study
研究组 & 干预措施
pemetrexed + platinum
Patients with pemetrexed + platinum doublet, with or without additional targeted agents
干预措施: Any platinum-based doublet chemotherapy (Drug)
gemcitabine + platinum
Patients with gemcitabine + platinum doublet, with or without additional targeted agents
干预措施: Any platinum-based doublet chemotherapy (Drug)
taxanes + platinum
Patients with taxanes + platinum doublet, with or without additional targeted agents
干预措施: Any platinum-based doublet chemotherapy (Drug)
vinorelbine + platinum
Patients with vinorelbine + platinum doublet, with or without additional targeted agents
干预措施: Any platinum-based doublet chemotherapy (Drug)
others + platinum
Patients with other platinum-based doublet, with or without additional targeted agents
干预措施: Any platinum-based doublet chemotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: Treatment start to death from any cause (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment)
次要结局
- One-year survival rate(12 months)
- Progression-free survival(Treatment start to progression or death (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment))
- Best tumor response(Treatment start to progression or treatment end)