CARE Initiative Study: Real-world Emulation of the KEYNOTE-189 Comparative Effectiveness Trial of Pembrolizumab, Pemetrexed, and Chemotherapy vs. Placebo, Pemetrexed, and Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aetion, Inc.
- 入组人数
- 304
- 主要终点
- Real-world overall survival (rwOS)
研究概览
简要总结
The goal of this non-interventional study is to emulate the KEYNOTE-189 randomized controlled trial of pembrolizumab for the treatment of metastatic non-small cell lung cancer using real-world, electronic health record data. The main questions this study aims to answer are:
- Do patients with metastatic non-small cell lung cancer (NSCLC) treated with pemetrexed, cisplatin/carboplatin, and pembrolizumab have improved real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) compared with patients treated with pemetrexed and cisplatin/carboplatin alone?
- How do the results of this non-interventional study compare to those of the KEYNOTE-189 randomized controlled trial?
详细描述
The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative is a program designed to build an empirical evidence base for the use of real-world data (RWD) in clinical and regulatory decision-making. Using randomized controlled trials (RCTs) as a benchmark for causal effect estimates, a series of RCT emulations will be conducted across varying trials, real world data sources, and study design elements to better understand under what conditions non-interventional studies, using data generated during routine clinical care, can provide reliable conclusions about drug effectiveness.
In this study, real-world electronic health record (EHR) data will be used to emulate the KEYNOTE-189 efficacy trial of pembrolizumab as first-line therapy in patients with metastatic non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) sensitizing mutations. Similarly to the KEYNOTE-189 trial, this study will compare real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) between patients who initiate pemetrexed, platinum-based chemotherapy, and pembrolizumab, and patients who initiate pemetrexed and platinum-based chemotherapy alone.
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
- •Non-small cell lung cancer (NSCLC) diagnosis
- •Histology not indicative of squamous cell carcinoma
- •Metastatic disease
- •Epidermal growth factor receptor (EGFR) and Anaplastic lymphoma kinase (ALK)-negative or Kirsten rat sarcoma viral oncogene homolog (KRAS)-positive
- •No prior systemic treatment for metastatic NSCLC
- •No record of adjuvant or neoadjuvant therapy in the 12 months before metastatic diagnosis
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or missing or Karnofsky performance status >=70 or missing
- •No lab results indicating inadequate organ function, as defined in the KEYNOTE-189 RCT protocol
排除标准
- •Histology indicative of squamous cell carcinoma or small cell elements
- •Receipt of an investigational agent or device in the 4 weeks before study drug initiation
- •Prior systemic treatment for metastatic NSCLC
- •Prior antineoplastic biological therapy
- •History of major cancer-related surgery in the 3 weeks before study drug initiation
- •Radiation therapy to the lung >30 Gy in the 6 months before study drug initiation
- •Prior diagnosis of clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction
- •Diagnosis of a second primary malignant neoplasm
- •Diagnosis of brain, central nervous system, and/or spinal cord metastases
- •Diagnosis of rheumatic disease in the 2 years prior to study drug initiation
- •Prior treatment with pembrolizumab or any other anti-PD-1, PD-L1, PDL2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- •Diagnosis of human immunodeficiency virus infection
研究组 & 干预措施
Exposed
Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC
干预措施: Pembrolizumab (Drug)
Exposed
Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC
干预措施: Pemetrexed (Drug)
Exposed
Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC
干预措施: Cisplatin (Drug)
Exposed
Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC
干预措施: Carboplatin (Drug)
Comparator
Patients initiating pemetrexed and cisplatin or carboplatin as first-line treatment for metastatic NSCLC
干预措施: Pemetrexed (Drug)
Comparator
Patients initiating pemetrexed and cisplatin or carboplatin as first-line treatment for metastatic NSCLC
干预措施: Cisplatin (Drug)
Comparator
Patients initiating pemetrexed and cisplatin or carboplatin as first-line treatment for metastatic NSCLC
干预措施: Carboplatin (Drug)
结局指标
主要结局
Real-world overall survival (rwOS)
时间窗: Study treatment initiation to death or censoring
Time from study treatment initiation to death
Real-world progression-free survival (rwPFS)
时间窗: Study treatment initiation to disease progression, death, or censoring
Time from study treatment initiation to disease progression or death
次要结局
未报告次要终点