CTIS2023-506074-12-00进行中（未招募）1 期
A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)? - MK-7684A-007
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 739
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC., Has not received prior systemic treatment for metastatic NSCLC., Has measurable disease based on RECIST 1.1, as determined by the local site assessment., Has a life expectancy of at least 3 months., Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method.
排除标准
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years., Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed., History of allogeneic tissue/solid organ transplant., Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)., Is unable or unwilling to take folic acid or vitamin B12 supplementation., Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention., Known active central nervous system (CNS) metastases and/or carcinomatous meningitis., Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients., Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication., Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)., History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Has an active infection requiring systemic therapy., Has a known history of human immunodeficiency virus (HIV), hepatitis B or/and hepatitis C virus., Received prior systemic anticancer therapy for metastatic disease.
研究者
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