NCT04794010进行中（未招募）不适用
A German, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 825 人开始时间: 2020年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 825
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of the study is to collect real-life data during the early post-market authorization approval period in Germany.
The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage IV Non-Small Cell Lung Cancer (NSCLC).
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
- •Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)- or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)
- •Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of NSCLC according to the German label has been made independently of the study
排除标准
- •Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- •Participants with known EGFR- or ALK-alterations
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 5 years
次要结局
- Management of AEs: Start of treatment(Up to 5 years)
- Overall Survival (OS) according to subgroups of interest(Up to 5 years)
- Treatment Patterns: Subsequent therapies(Up to 5 years)
- Duration of treatment(Up to 5 years)
- Distribution of clinical characteristics of participants(At Baseline)
- Progression-free survival (PFS)(Up to 5 years)
- Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires(Up to 5 years)
- Treatment patterns: Concomitant medication(Up to 5 years)
- Distribution of socio-demographic characteristics of participants(At Baseline)
- Management of AEs: Treatment of AEs(Up to 5 years)
- Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies(Up to 5 years)
- Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)(Up to 5 years)
- Management of AEs: Date of occurrence of AE(Up to 5 years)
- Treatment Patterns: Previous therapies(Up to 5 years)
研究者
研究点 (1)
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