JPRN-jRCT2031230049招募中3 期
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, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
Koh Yasuhiro0 个研究点目标入组 39 人开始时间: 2023年4月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).
- •-Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
- •-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 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 (>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.
- •-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 past 2 years.
- •-Has an active infection requiring systemic therapy.
- •-Has a history of human immunodeficiency virus (HIV) infection.
- •-Has a history of Hepatitis B or C.
- •-Has not adequately recovered from major surgery or has ongoing surgical complications.
- •-Has a history of allogenic tissue/solid organ transplant.
研究者
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