A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 67
- 主要终点
- Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
研究概览
简要总结
Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body.
Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.
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
- None
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
- •Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
- •Measurable disease as assessed by the local site investigator/radiology.
排除标准
- •Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- •Received prior systemic anticancer therapy for their metastatic NSCLC.
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Active infection requiring systemic therapy.
研究组 & 干预措施
Pembrolizumab
"Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course,
干预措施: Pembrolizumab (Biological)
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
干预措施: Pembrolizumab (+) Berahyaluronidase alfa (Biological)
结局指标
主要结局
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
时间窗: At designated time points (up to approximately 14 months)
AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
时间窗: At designated time points (Up to ~15 months)
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough
次要结局
- Number of Participants Who Experience an AE- All Participants(Up to approximately 28 months)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 25 months)