Real-World Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Pd-L1 <1% in the Florida Cancer Specialists & Research Institute Database
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related adverse events
研究概览
简要总结
The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy
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
- •Inclusion Criteria:
- •Are ≥ 18 years of age at the index date
- •Have a confirmed diagnosis of advanced/metastatic non-small cell lung cancer (NSCLC) (stage IIIB-IV) (squamous and non-squamous)
- •Have PD-L1< 1% level as reported
- •Received one of the following 1L treatments:
- •Cohort 1: nivolumab + ipilimumab
- •Cohort 2: nivolumab + ipilimumab + platinum-based chemotherapy
- •Cohort 3: Immuno-oncology (IO)-based therapy (excluding nivolumab-based regimens) with chemotherapy
- •Cohort 4: Dual-IO with chemotherapy (eg. tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + [carboplatin or cisplatin] + gemcitabine, tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + [carboplatin or cisplatin] + pemetrexed)
- •Have ≥ 6 months of documented post-index (follow-up) period after the index date - Participants who die within 6 months of follow-up will be included
排除标准
- •Have positive or unknown EGFR or ALK mutation before the index date
- •Have a gap of > 120 days between metastatic NSCLC diagnosis and index date
- •Were included in a clinical trial for 1L therapy
- •Enter a hospice within 6 months of the follow-up will be excluded
- •Have other concurrent primary cancer diagnoses
研究组 & 干预措施
Cohort 1
Participants receiving nivolumab + ipilimumab treatment
干预措施: Nivolumab + ipilimumab (Biological)
Cohort 2
Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy
干预措施: Nivolumab + ipilimumab + platinum-based chemotherapy (Biological)
Cohort 3
Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment
干预措施: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy (Biological)
Cohort 4
Participants receiving other dual-IO with chemotherapy
干预措施: Other dual-immuno-oncology therapy with chemotherapy (Biological)
结局指标
主要结局
Incidence of treatment-related adverse events
时间窗: Baseline
Time to onset of treatment-related adverse events
时间窗: Up to 8 years
Number of treatment-related adverse events resolved
时间窗: Up to 8 years
Participant baseline clinical characteristics
时间窗: Baseline
Number of participants receiving treatment for treatment-related adverse events by drug class
时间窗: Up to 8 years
Number of participants that discontinued immune-oncology therapy due to treatment-related adverse events
时间窗: Up to 8 years
次要结局
- Healthcare Resource Utilization (HCRU) associated with treatment-related adverse event(Up to 8 years)