NCT06487156进行中（未招募）不适用
FINN (First-line Ipilimumab + Nivolumab in NSCLC): An Italy, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2023年10月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy
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 or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations
- •Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study
- •Patient is at least 18 years of age at time of treatment decision
- •Patient provided written informed consent to participate in the study
排除标准
- •Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- •Patients with known EGFR- or ALK-alterations
- •Previous treatment with nivolumab and/or ipilimumab
- •Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)
研究组 & 干预措施
Participants receiving first-line nivolumab plus ipilimumab
干预措施: Nivolumab + ipilimumab (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 5 years
次要结局
- Progression-free survival (PFS)(Up to 5 years)
- Treatment regimen(Up to 5 years)
- Number of participants discontinuing treatment(Up to 5 years)
- Participant clinical characteristics(Baseline and up to 5 years)
- Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria(Up to 5 years)
- Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results(Baseline and up to 5 years)
- Overall response rate (ORR)(Up to 5 years)
- Best overall response (BOR)(Up to 5 years)
- Best overall response rate (BORR)(Up to 5 years)
- Duration of response (DOR)(Up to 5 years)
- Time to response (TTR)(Up to 5 years)
- European Quality of Life-5 Dimensions (EQ-5D) Score(Baseline and up to 5 years)
- Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results(Baseline)
- Management of Adverse Events (AEs)(Up to 5 years)
- Participant socio-demographic characteristics(Baseline and up to 5 years)
研究者
研究点 (1)
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