A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 ≥50%
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessments
研究概览
简要总结
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or stage IV disease, who received no prior systemic treatment for recurrent or metastatic NSCLC
- •Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample which has not previously been irradiated
- •Expression of PD-L1 in ≥50% of tumor cells determined by the commercially available assay performed by the central laboratory
- •At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Anticipated life expectancy of at least 3 months
排除标准
- •Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- •Active or untreated brain metastases or spinal cord compression
- •Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
- •Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- •History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
- •Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs)
- •Previous treatment with idelalisib at any time (ZYDELIG®)
- •Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
REGN2810/ipi
REGN2810/ipi
干预措施: REGN2810/ipi (Drug)
REGN2810/chemo/ipi
REGN2810/chemo/ipi
干预措施: REGN2810/chemo/ipi (Drug)
Pembrolizumab
Pembrolizumab
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessments
时间窗: Up to 32 months
Per protocol, the final analysis of PFS was to be performed after observing 142 PFS events in the pembrolizumab treatment arm. PFS was not assessed due to insufficient data collected.
次要结局
- Overall Survival (OS)(Up to 32 months)
- Objective Response Rate (ORR)(Up to 32 months)
- Number of Participants With Any Serious TEAEs(Up to 32 months)
- Number of Participants With TEAEs Leading to Death(Up to 32 months)
- Number of Treatment-Emergent Adverse Events (TEAEs)(Up to 32 months)
- Number of Participants With Dose-Limiting Toxicities (DLTs)(Up to 32 months)
- Overall Survival (OS) at 18 Months(At 18 months)
- Number of Participants With Laboratory Abnormalities(Up to 32 months)
- Overall Survival (OS) at 12 Months(At 12 months)
- Quality of Life (Core 30 Questionnaire)(Up to 32 months)
- Quality of Life (Lung Cancer 13 Questionnaire)(Up to 32 months)