jRCT2031240445尚未招募不适用
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
- 不适用
- 状态
- 尚未招募
- 发起方
- MSD K.K.
- 入组人数
- 20
- 主要终点
- Steady-state (Cycle 3) Ctrough
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC.
- •Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
- •Has a life expectancy of at least 3 months.
排除标准
- •Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- •Has received prior systemic anticancer therapy for their metastatic NSCLC.
- •Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- •Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids.
- •Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- •Has an active infection requiring systemic therapy.
- •Has a history of HIV infection.
- •Has a history of Hepatitis B or known active Hepatitis C virus infection.
- •Has a history of allogeneic tissue/solid organ transplant.
- •Has not adequately recovered from major surgery or have ongoing surgical complications.
结局指标
主要结局
Steady-state (Cycle 3) Ctrough
时间窗: Cycle 3 (steady-state)
The primary analysis will be performed on the model-based values of Ctrough
次要结局
未报告次要终点
研究者
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