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 - MK3475A-D77

Merck Sharp & Dohme LLC0 个研究点目标入组 393 人开始时间: 2022年11月30日最近更新: 2024年8月21日

适应症

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•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

•Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements, 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, 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

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