JPRN-jRCT2031220098进行中（未招募）3 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)
ohata Nijiro0 个研究点目标入组 46 人开始时间: 2022年5月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
- •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 Response Evaluation Criteria in Solid Tumors (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.
- •- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •- Severe hypersensitivity to vibostolimab, 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 (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •- 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.
- •- 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 allogenic 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.
研究者
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