Real-world Data and Economic Evaluation of Nivolumab in Previously Treated NSCLC Patients in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 346
- 主要终点
- Description of real world clinical use of Nivolumab in pre-treated NSCLC patients
研究概览
简要总结
Nivolumab is an approved treatment option for patients with previously treated advanced NSCLC, based on the survival benefit shown versus docetaxel in randomized phase III trials in second line. However, the profile of treatment and even patient outcomes are often different in routine clinical practice than in a clinical trial setting. Furthermore, the financial impact of an approved therapy is often largely unknown. This study will record the efficacy and tolerability of Nivolumab in previously treated patients with NSCLC and describe the treatment patterns and economic impact in real-world settings in Greece.
详细描述
Patients with advanced NSCLC who had received nivolumab as 2nd line and beyond, between October 2015 and November 2019, in HeCOG clinical centres in Greece, were enrolled. Information regarding detailed patient and treatment characteristics including post-nivolumab therapies, efficacy, and safety data of nivolumab treatment and additionally data on costs and other economic values are collected, analysed and compared with historical data in order to describe the real-world patterns of Nivolumab use in 2nd line NSCLC therapy in Greece.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with a diagnosis of advanced Squamous or Non-Squamous NSCLC (histologically or cytologically confirmed), who had relapsed after 1 prior platinum-based systemic treatment and who received treatment with nivolumab
- •nivolumab treatment received in participating HeCOG centres between October 2015 and November 2019
- •Alive patients must have signed and dated the study approved written informed consent form in accordance with regulatory and institutional guidelines, obtained before any protocol-related procedures that are not part of normal patient care.
排除标准
- •Alive patients who do not want to sign and date the study approved written informed consent form
- •Patients that participated in any other clinical trial prior or after nivolumab treatment
结局指标
主要结局
Description of real world clinical use of Nivolumab in pre-treated NSCLC patients
时间窗: approximately 12 months
Real-world clinical use
overall survival (OS)
时间窗: approximately 12 months
Measured from time of initial treatment with nivolumab until date of death
次要结局
- Cost-effectiveness(approximately 12 months)
- Objective Response Rate (ORR) as assessed by investigator(approximately 12 months)