A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 315
- 试验地点
- 401
- 主要终点
- Objective response (OR)
研究概览
简要总结
The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
- •Participant has no prior systemic treatment for advanced disease.
- •Measurable disease according to RECIST v1.
- •Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
- •Eastern Cooperative Oncology Group performance status score 0 or
- •Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and c-ros oncogene 1, receptor tyrosine kinase of the insulin receptor family (ROS-1) negative
- •Have a life expectancy of at least 3 months.
排除标准
- •Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
- •Participant has active central nervous system metastases not previously treated.
- •Participant has active or known immune-mediated disorders.
- •Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
- •Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.
研究组 & 干预措施
ABP 234
Part 1: Participants will receive ABP 234 followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive ABP 234 followed by pemetrexed.
干预措施: ABP 234 (Drug)
Pembrolizumab (US)
Part 1: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed.
干预措施: Pembrolizumab (US) (Drug)
Pembrolizumab (EU)
Part 1: Participants will receive EU-approved pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive EU-approved pembrolizumab followed by pemetrexed.
干预措施: Pembrolizumab (EU) (Drug)
结局指标
主要结局
Objective response (OR)
时间窗: Week 49
OR defined as an overall response of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234
时间窗: 21 days
AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234
时间窗: Week 16 through Week 19
AUC21d of pembrolizumab (EU)
时间窗: 21 days
AUCtau_ss of pembrolizumab (US)
时间窗: Week 16 through Week 19
AUC21d of pembrolizumab (US)
时间窗: 21 days
AUCtau_ss of pembrolizumab (EU)
时间窗: Week 16 through Week 19
次要结局
- OR(Week 31)
- Duration of response (DOR)(Up to 2.5 years)
- Progression-free survival (PFS)(Up to 2.5 years)
- Cmax_dose1 of pembrolizumab (US)(Day 1 up to Week 107)
- Cmax_dose1 of pembrolizumab (EU)(Day 1 up to Week 107)
- Overall survival (OS)(Up to 2.5 years)
- Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234(Day 1 up to Week 107)
- Time to maximum concentration following the first dose (tmax_dose1) of ABP 234(Day 1 up to Week 107)
- Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234(Week 16 through Week 19)
- Tmax_dose1 of pembrolizumab (US)(Day 1 up to Week 107)
- Tmax_dose1 of pembrolizumab (EU)(Day 1 up to Week 107)
- Cmax_ss of pembrolizumab (US)(Week 16 through Week 19)
- Cmax_ss of of pembrolizumab (EU)(Week 16 through Week 19)
- Tmax_ss of pembrolizumab (US)(Week 16 through Week 19)
- Ctrough_w4 of pembrolizumab (US)(Week 4)
- Ctrough_w4 of pembrolizumab (EU)(Week 4)
- Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234(Week 16 through Week 19)
- Time to maximum concentration at steady state (tmax_ss) of ABP 234(Week 16 through Week 19)
- Tmax_ss of pembrolizumab (EU)(Week 16 through Week 19)
- Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234(Week 4)
- AUC21d of pembrolizumab (US)(21 days)
- AUC21d of pembrolizumab (EU)(21 days)
- Number of participants who experience anti-drug antibodies (ADA)(Up to 2.5 years)
- Ctrough_ss at pre-dose of pembrolizumab (US)(Week 16 through Week 19)
- Ctrough_ss at pre-dose of pembrolizumab (EU)(Week 16 through Week 19)
- AUCtau_ss of pembrolizumab (US)(Week 16 through Week 19)
- AUCtau_ss pembrolizumab (EU)(Week 16 through Week 19)
- Number of participants who experience a Treatment-emergent adverse event(Up to 2.5 years)
- Number of participants who experience a Treatment-emergent serious adverse event(Up to 2.5 years)
- Number of participants who experience a Treatment-emergent adverse event of interest(Up to 2.5 years)
- Objective response (OR)(Week 49)
- OR(Week 13)