NCT02910999已完成不适用
A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology (Stage IIIB/IV) After Prior Chemotherapy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 868 人开始时间: 2016年8月9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
- 868
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.
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
- •Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
- •Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
- •Males and Females, ≥18 years of age
排除标准
- •Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
- •Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
- •Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Overall Survival (OS)
时间窗: Approximately 5 years
次要结局
- Distribution of Incidence of All Adverse Events (AEs)(Approximately 5 years)
- Progression-Free Survival (PFS)(Approximately 5 years)
- Overall Response Rate (ORR)(Approximately 5 years)
- Distribution of clinical characteristics in adult patients diagnosed with advanced NSCLC(At baseline and for up to 5 years)
- Best Overall Response Rate (BORR)(Approximately 5 years)
- Best Overall Response (BOR)(Approximately 5 years)
- Duration of Response (DOR)(Approximately 5 years)
- Distribution of socio-demographic characteristics in adult patients diagnosed with advanced NSCLC(At baseline and for up to 5 years)
- Distribution of Management of All Adverse Events (AEs)(Approximately 5 years)
- Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC(At baseline and for up to 5 years)
- Distribution of Severity of All Adverse Events (AEs)(Approximately 5 years)
- European Quality of Life-5 Dimensions (EQ-5D)(At baseline and for up to 5 years)
- Lung Cancer Symptom Scale (LCSS)(At baseline and for up to 5 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs.Advanced NSCLC patients with IIPsJPRN-UMIN000022037Kobe city medical center general hospital6
已完成
不适用
Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab TherapyMelanomaNCT02990611Bristol-Myers Squibb1,087
进行中（未招募）
不适用
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric CancerGastric CancerNCT05165264Bristol-Myers Squibb600
已完成
不适用
Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU ProgramNivolumabLong-term Adverse EffectsNon-small Cell Lung CancerNCT02933346Intergroupe Francophone de Cancerologie Thoracique907
已完成
不适用
Real-world Data of Nivolumab in Pre-treated NSCLCNon Small Cell Lung CancerNCT04713462Hellenic Cooperative Oncology Group346