NCT07162883尚未招募3 期
A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of QL2107 (Keytruda® Biosimilar Candidate) in Comparison With Keytruda® (Pembrolizumab) for Adjuvant Therapy to Demonstrate Pharmacokinetic Similarity in Subjects With Resected Non-Small Cell Lung Cancer
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 122
- 主要终点
- AUCtau,sd of QL2107 and Keytruda
研究概览
简要总结
The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (male or female) more than and equal to 18 years of age on the day of signing the ICF.
- •Disease status: Participants with completely resected, histologically- or cytologically-confirmed (Stage II or IIIA) NSCLC
- •Treatment with platinum-based chemotherapy; • Chemotherapy must have begun within 12 weeks after the resection surgery. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized.
- •No evidence of disease (NSCLC) for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) and/or magnetic resonance imaging (MRI) and brain CT/MRI within 12 weeks prior to the randomization date.
- •Eastern Cooperative Oncology Group performance status of 0 or 1.
排除标准
- •Surgical-related adverse events (AEs) or chemotherapy-related toxicity not resolved to Grade 1, with the exception of Grade <=2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
- •Participants who have received systemic corticosteroids (more than [>] 10 mg prednisone daily or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or tumor necrosis factor alpha inhibitors) within 2 weeks prior to the first dose.
- •Participants with known epidermal growth factor receptor (EGFR)-sensitive mutations or anaplastic lymphoma kinase (ALK) gene translocations are not allowed.
- •Received prior therapy with an anticytotoxic T-lymphocyte antigen-4 mAb (example, ipilimumab); anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (Programmed Death-Ligand 1), or anti-programmed cell death ligand 2 (PD-L2) agent; or agent directed to another stimulatory or co-inhibitory T cell receptor.
- •Participants with any active autoimmune disease or history of autoimmune diseases including but not limited to autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism.
研究组 & 干预措施
QL2107 200mg
Experimental
Participants will receive QL2107 200 milligrams (mg) intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21 days treatment cycle for up to 17 treatment cycles.
干预措施: QL2107 (Drug)
Keytruda® 200 mg
Active Comparator
Participants will receive Keytruda® 200 mg IV infusion Q3W, on Day 1 of each 21- days treatment cycle for up to 17 treatment cycles.
干预措施: Keytruda® (Drug)
结局指标
主要结局
AUCtau,sd of QL2107 and Keytruda
时间窗: At Cycle 1 (cycle length = 21 days)]
Area under the concentration time curve for 1 dosing interval (tau = 21 days) after a single initial) dose (AUCtau,sd) of QL2107 and Keytruda® will be reported.
AUCtau,ss of QL2107 and Keytruda
时间窗: At Cycle 7 (cycle length = 21 days)]
Area under the concentration time curve for 1 dosing interval (tau = 21 days) at steady state (AUCtau,ss) of QL2107 and Keytruda® will be reported.
次要结局
- Cmax,sd of QL2107 and Keytruda(At Cycle 1 (cycle length = 21 days)])
- Ctrough of QL2107 and Keytruda(Up to Cycle 10 at Predose (cycle length = 21 days))
- Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)(Up to Week 52)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to Week 52)
- Cmax,ss of QL2107 and Keytruda(At Cycle 7 (cycle length = 21 days)])
研究者
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