Long-Term Real-World Outcomes Among Patients With Programmed Death-Ligand 1 (PD-L1) <1% Metastatic Non-Small Cell Lung Cancer (mNSCLC) Treated With First-Line (1l) Nivolumab + Ipilimumab + 2 Cycles Of Chemotherapy (NIC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Participant baseline socio-demographics
研究概览
简要总结
The study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 old at confirmed diagnosis with metastatic non-small cell lung cancer (NSCLC) (stage IV), squamous or non-squamous histology
- •Initiated first-line (1L) combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) regimen between 01 January 2018 and 2 years prior to study launch
- •Tumor programmed death-ligand 1 (PD-L1) negative expression (i.e., PD-L1 <1%)
- •No EGFR, ALK, or ROS1 genetic mutation (i.e., wild type)
- •Minimum of 6 months of follow-up after initiation of 1L NIC*
排除标准
- •Any prior systemic therapy for metastatic non-small cell lung cancer (NSCLC)
研究组 & 干预措施
Cohort 1
Adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US
干预措施: nivolumab + ipilimumab (Biological)
结局指标
主要结局
Participant baseline socio-demographics
时间窗: Baseline
Participant baseline clinical characteristics
时间窗: Baseline
Participant treatment history
时间窗: Baseline
Treatment start and stop dates
时间窗: Up to 6-months
Reasons for 1L treatment selection
时间窗: Day 1
Initial 1L NIC treatment dose received
时间窗: Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Type of chemotherapy received as part of NIC treatment
时间窗: Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Participant NIC treatment chemotherapy schedule
时间窗: Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Number of NIC treatment interruptions
时间窗: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Date(s) of NIC treatment interruptions
时间窗: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Reasons for NIC treatment interruptions
时间窗: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Length of NIC treatment delay/interruption
时间窗: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Reasons for NIC treatment discontinuation
时间窗: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Type of 2L treatment received
时间窗: Up to 6-months
Reasons for not initiating 2L treatment
时间窗: Up to 6-months
Start and stop dates of 2L treatment initiation
时间窗: Up to 6-months
次要结局
未报告次要终点