NCT03273790已完成不适用
Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients - Retrospective Study of Japanese Real-World Data Through Clinical Chart Review
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 939 人开始时间: 2017年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 939
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously treated advanced/metastatic NSCLC patients treated with nivolumab at least once from 01-Apr-2016 through 31-Dec-2016
排除标准
- •Patients who meets the inclusion criteria will be included in the analysis to describe real-world clinical usage of nivolumab. However, patients treated with nivolumab falling in following criteria will be excluded for analysis for the other primary endpoint; overall effectiveness:
- •History of participation in any clinical trials prior- or post-nivolumab treatment
- •Patients who are a part of a Post-marketing surveillance study
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Approximately 9 months
Time since index date (initial diagnosis and treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first
Description of clinical usage of nivolumab in previously treated NSCLC patients
时间窗: Approximately 9 months
Overall Survival (OS)
时间窗: Approximately 9 months
Measured from time of initial diagnosis and treatment with nivolumab until date of death
次要结局
- Percentage of patients receiving nivolumab as second or later line of therapy(Approximately 9 months)
- Objective Response Rate (ORR) as assessed by investigator(Approximately 9 months)
- Percentage of patients receiving monotherapy or combination therapy(Approximately 9 months)
- Median treatment duration and range by line and histology(Approximately 9 months)
- Percentage of patients receiving bi-weekly nivolumab(Approximately 9 months)
- Reasons for discontinuation of nivolumab(Approximately 9 months)
- Reasons for re-challenge of nivolumab(Approximately 9 months)
- Rate of permanent and temporary discontinuations(Approximately 9 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
4 期
ivolumab Safety StudyCTRI/2018/02/012088BRISTOLMYERS SQUIBB INDIA PRIVATE LIMITED
已完成
2 期
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)Hodgkin DiseaseNCT02181738Bristol-Myers Squibb294
已完成
3 期
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the CancerVarious Advanced CancerNCT02632409Bristol-Myers Squibb709
已完成
4 期
Study of Nivolumab for Advanced Cancers in IndiaNon-Small Cell Lung Cancer (NSCLC)Non-Small-Cell Lung CarcinomaNonsmall Cell Lung CancerKidney CancerKidney NeoplasmsRenal CancerRenal NeoplasmsNCT03444766Bristol-Myers Squibb100
已完成
1 期
A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid TumorsSolid TumorNCT03195478Bristol-Myers Squibb37