A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 555
- 试验地点
- 93
- 主要终点
- Objective response rate (ORR) at Week 24
研究概览
简要总结
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:
• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.
Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female ≥ 18 years of age
- •Have been diagnosed with stage IV non-squamous NSCLC
- •Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
- •Agree to use adequate methods of contraception
排除标准
- •Unable or unwilling to take folic acid and vitamin B12 supplementation
- •Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.
研究组 & 干预措施
Keytruda
Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
干预措施: Keytruda (Drug)
SB27
SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
干预措施: SB27 (Drug)
结局指标
主要结局
Objective response rate (ORR) at Week 24
时间窗: At Week 24
Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) at Week 24 according to RECIST v1.1
次要结局
未报告次要终点