EVIDENS: Lung Cancer Patients Treated With Nivolumab: A Longitudinal, Prospective, Observational, Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,462
- 试验地点
- 1
- 主要终点
- Number of patients with PD-L1 expression at nivolumab initiation
研究概览
简要总结
This study will describe the characteristics of patients initiating nivolumab treatment for lung cancer and their outcomes over 3 years in France
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
- •Male or female: 18 age at the time of nivolumab initiation
- •Pathologically confirmed diagnosis of lung cancer
- •Patient initiating nivolumab :therapeutic decision to initiate nivolumab must be taken by the physician prior to enrolling a patient in the study
排除标准
- •Patient taking part in an interventional study for lung cancer treatment for which nivolumab is 1 of the investigational drugs
- •Other protocol defined inclusion or exclusion criteria could apply
结局指标
主要结局
Number of patients with PD-L1 expression at nivolumab initiation
时间窗: At baseline
PD-LI (Programmed death-ligand 1)
Distribution of cancer stage at initial diagnosis and at nivolumab initiation
时间窗: At baseline
Number of patients with treated brain metastasis at nivolumab initiation
时间窗: At baseline
(OS) Overall Survival
时间窗: Up to 3 years
Time from index date (treatment with nivolumab) until date of death due to any cause
Distribution of ECOG PS
时间窗: At baseline
Eastern Cooperative Oncology Group Performance Status (ECOG PS) A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis
Distribution of patients working status at nivolumab initiation
时间窗: At baseline
Distribution of Lung cancer histology at initial diagnosis
时间窗: At baseline
Distribution of gender
时间窗: At baseline
Distribution of line of therapy at nivolumab initiation
时间窗: At baseline
Number of patients exposed to other lung cancer treatments
时间窗: At baseline
Distribution of current smokers, former smokers, and non-smokers at initial diagnosis
时间窗: At baseline
Number of patients with untreated brain metastasis at nivolumab initiation
时间窗: At baseline
Number of patients with mutations at nivolumab initiation
时间窗: At baseline
Median time from initial diagnosis to nivolumab initiation
时间窗: At baseline
Median time from initial diagnosis to nivolumab initiation (derived from date of initial diagnosis and date of first dose of nivolumab, assumed to be the date of D0 visit). Any lung cancer declaring more than 5 years after another cancer is defined as an initial diagnosis of lung cancer
Distribution of concomitant diseases at nivolumab initiation
时间窗: At baseline
Number of patients with corticosteroids treatment at nivolumab initiation
时间窗: At baseline
Distribution of age
时间窗: At baseline
QoL (EQ-5D) at nivolumab initiation
时间窗: At baseline
Quality of Life (QoL) as assessed by European Quality of Life-5 Dimensions (EQ-5D) EQ-5D: the descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with 3 levels (eg, no problems, moderate problems, extreme problems)
次要结局
- Distribution of patient management treatment patterns(Baseline to 3 years)
- Overall Survival after initiation of nivolumab(Up to 2 years)
- Distribution of nivolumab adverse drug reaction(At 3 years after nivolumab initiation)
- Distribution of patients with new metastasis(Up to 3 years)
- Mean weight change in kilogram from baseline(Baseline up to 3 years)
- Distribution of patients with progression of pre-existing sites(Up to 3 years)
- Progression Free Survival (PFS)(Up to 3 years after nivolumab initiation)
- Quality of Life (QoL)(Baseline to 3 years after nivolumab initiation)
- Objective Response Rate (ORR)(Up to 3 years after nivolumab initiation)
- Mean ECOG PS change from baseline(Baseline up to 3 years)