A Non-interventional Study of Nab-paclitaxel (Abraxane®) in Combination With Carboplatin as First Line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NEPTUN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) rate
研究概览
简要总结
This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and quality of life (QoL) in patients with advanced NSCLC receiving the combination of nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.
详细描述
The present NIS is designed to provide additional knowledge in terms of effectiveness, safety and quality of life in routine administration of the combination of nab-paclitaxel (Abraxane®) and carboplatin as first line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for potentially curative surgery and / or radiation therapy. The combination of Abraxane® and carboplatin has been approved in Europe in March 2015 based on results from a pivotal randomized, open label phase III study with 1,052 patients.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC
- •According to SmPC
排除标准
- •According to SmPC
结局指标
主要结局
Progression Free Survival (PFS) rate
时间窗: After 6-months
Effectiveness in terms of PFS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months). Additional survival and and if applicable clinical PFS will be followed up for 24 months post-treatment observation.
次要结局
- Overall Response Rate (ORR)(After 6-months)
- Safety - Adverse events (AEs)(through study completion, an average of 9 months)
- Patient-reported outcomes on Quality of Life(Baseline, after 6 weeks, after 3 months, every 3 months throughout study completion, an average of 9 months)
- Median Overall Survival (OS)(After 6-months)
- Rationale for physicians' treatment decision(Baseline)