An Observational Study to Assess the Effectiveness and Safety of Cemiplimab Based Regimen in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 94
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care.
The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.
详细描述
Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023.
The recruitment period will be 48 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 24 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.
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
- •At least 18 years of age at the time of cemiplimab treatment initiation
- •Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC
- •Prescribed a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the Summary of Product Characteristics (SmPC).
- •Can understand and complete the study-related questionnaires
- •Must be legally capable of providing written consent for participation in the study and have signed informed consent prior to any study activities
排除标准
- •Has received cemiplimab prior to enrollment
- •Has uncontrolled autoimmune disease
- •Has a contraindication to cemiplimab as noted in the local SmPC
- •Is concurrently participating in any other study of an investigational drug or procedure
- •Has cognitive impairment or other medical condition that, in the opinion of the investigator, would interfere with the ability to complete the study-related questionnaires
- •NOTE: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Cohort 1
Cemiplimab monotherapy
干预措施: Cemiplimab (Drug)
Cohort 2
Cemiplimab in combination with platinum-based chemotherapy
干预措施: Cemiplimab (Drug)
Cohort 2
Cemiplimab in combination with platinum-based chemotherapy
干预措施: Platinum-based chemotherapy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 72 months
Date and primary cause of death
次要结局
- Duration of Response (DoR)(Up to 72 months)
- Time to Response (TTR)(Up to 72 months)
- Progression-Free Survival (PFS)(Up to 72 months)
- Time to first subsequent anti-NSCLC treatment (TTST)(Up to 72 months)
- Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice(Up to 72 months)
- Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice(Up to 72 months)
- Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice(Up to 72 months)
- Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice(Up to 72 months)
- Overall Response Rate (ORR)(Up to 72 months)