NCT06430866招募中3 期
A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 154
- 试验地点
- 238
- 主要终点
- Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose
研究概览
简要总结
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
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
- •Males and females ≥ 18 years of age.
- •Pathological diagnosis of non-squamous NSCLC.
- •Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy.
- •For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers.
- •Treated 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.
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or
- •Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative.
- •Have adequate organ function as indicated by laboratory values.
- •Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration.
- •Participants must sign approved informed consent form (ICF).
排除标准
- •Evidence of disease.
- •Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting.
- •History or presence of immune-mediated disorders.
- •Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll.
- •Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV).
- •History of congenital immunodeficiency diseases, prior allogeneic stem cell transplantation, or organ transplantation.
- •History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc.
- •Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis.
- •Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
- •Woman of childbearing potential who is pregnant or is breast feeding.
- •Woman of childbearing potential who is not consenting to use highly effective methods of birth control.
- •Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control.
- •Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP).
- •Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study.
- •Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease.
- •Live vaccine therapy within 4 weeks prior to IP administration.
- •Participation in another investigational drug study within 30 days prior to IP administration.
研究组 & 干预措施
ABP 234
Experimental
Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.
干预措施: ABP 234 (Drug)
Pembrolizumab
Active Comparator
Participants will receive pembrolizumab Q3W for up to 12 months.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose
时间窗: 21 days
AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)
时间窗: Weeks 16-19
次要结局
- Tmax at Steady State (Tmax_ss)(Weeks 16-19)
- Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)(Up to 65 weeks)
- Number of Participants with Andit-drug Antibodies(Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65)
- Disease-free Survival(Up to 65 weeks)
- Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)(Week 4 pre-dose)
- Ctrough at Stead State (Ctrough_ss)(Weeks 16 and 19 pre-dose)
- Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)(Up to 65 weeks)
- Cmax at Steady State (Cmax_ss)(Weeks 16-19)
- Number of Participants with Treatment-emergent Adverse Events(Up to 16 months)
- Number of Participants with Treatment-emergent Serious Adverse Events(Up to 16 months)
- Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)(Up to 16 months)
研究者
研究点 (238)
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