A Phase I, Randomised, Double-blind, Three-arm, Parallel Group, Multicentre Study to Compare the Pharmacokinetics (PK), Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, European Union [EU] Sourced Keytruda, and the United States of America [US] Sourced Keytruda) in Subjects With Stage II-IIIA Non-small Cell Lung Cancer Following Complete Resection and Adjuvant Platinum-based Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 163
- 试验地点
- 24
- 主要终点
- Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6
研究概览
简要总结
The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:
• What the body does to the study drug, which is called "pharmacokinetic"
Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.
Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced 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 aged 18 years or older
- •Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
- •Have completely removed all of the cancer from the body surgically
- •Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery
排除标准
- •Have received anti-cancer therapy before surgery
- •Have or had autoimmune disease in past 5 years
研究组 & 干预措施
SB27
SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
干预措施: SB27 (Drug)
EU sourced Keytruda
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
干预措施: EU sourced Keytruda (Drug)
US sourced Keytruda
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
干预措施: US sourced Keytruda (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6
时间窗: At the end of Cycle 6 (each cycle is 21 days)
Defined as AUC calculated in Cycle 6 based on intensive PK assessment
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1
时间窗: At the end of Cycle 1 (each cycle is 21 days)
Defined as AUC calculated in Cycle 1 based on intensive PK assessment
次要结局
- Overall Survival(From the date of randomization until the date of death of any cause, assessed up to Week 55)
- Disease-free Survival(From the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first, assessed up to Week 55)