2023-506074-12-00招募中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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 27
- 主要终点
- Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
研究概览
简要总结
- To compare MK-7684A in combination with chemotherapy to pembrolizumab in combination with chemotherapy with respect to Overall Survival (OS) in participants with PD-L1 TPS ≥1%
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
次要结局
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR)
- Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
- Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
- Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
- Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
- Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
- Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13
- Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
- TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30
- TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
- TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
- TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
- TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
- Number of Participants Who Experienced One or More Adverse Events (AEs)
- Number of Participants Who Discontinued Study Intervention Due to an AE
- Duration of Response (DOR)
研究者
Pierre Leconte
Scientific
Merck Sharp & Dohme LLC
研究点 (27)
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