2023-503501-11-00招募中3 期
An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator- Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTED46/EVOKE-03)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 37
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
- To compare pembrolizumab in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review
- To compare pembrolizumab in combination with sacituzumab govitecan with pembrolizumab alone with respect to overall survival
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
- •Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy
- •Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- •Has a life expectancy of at least 3 months
排除标准
- •Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- •Has active chronic inflammatory bowel disease
- •Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients
- •Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has active infection requiring systemic therapy
- •Has history of human immunodeficiency virus (HIV) infection
- •History of hepatitis B or known active hepatitis C virus infection
- •Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
- •Have not adequately recovered from major surgery or have ongoing surgical complications
- •Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapy
- •Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- •Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids
- •Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study intervention
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- •Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
- •Has cardiac disease * Myocardial infarction or unstable angina pectoris within 6 months of enrollment * History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications; history of QT interval prolongation * New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%
结局指标
主要结局
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Objective Response (OR)
- Duration of Response (DOR)
- 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 in Role Functioning (Items 6-7) 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 Questionnaire - Lung Cancer 13 (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 6-7) 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 in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Renata Eiras Martins
Scientific
Merck Sharp & Dohme LLC
研究点 (37)
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