jRCT2051240089招募中不适用
A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50%
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MSD K.K.
- 入组人数
- 40
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
- •Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
- •Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in >=50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
- •A life expectancy of at least 3 months.
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
排除标准
- •Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- •Has Grade >=2 peripheral neuropathy.
- •History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
- •Received prior systemic anticancer therapy for their metastatic NSCLC.
- •Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- •Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- •Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
- •Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- •Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- •Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- •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.
- •Known intolerance to MK-2870 or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (>=Grade 3) is exclusionary.
- •Known hypersensitivity to MK-2870 or other biologic therapy.
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
- •History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
- •Active infection requiring systemic therapy
- •Concurrent active Hepatitis B and Hepatitis C virus infection.
- •Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- •History of allogeneic tissue/solid organ transplant.
- •Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 48 months
OS is defined as the time from randomization to death from any cause.
次要结局
- Progression free survival (PFS)(Up to approximately 48 months)
- Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score(Baseline and up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 48 months)
- Objective Response (OR)(Up to approximately 48 months)
- Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score(Baseline and up to approximately 24 months)
- Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score(Baseline and up to approximately 24 months)
- Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score(Baseline and up to approximately 24 months)
- Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30)(Up to approximately 24 months)
- Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)(Up to approximately 24 months)
- Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31).(Up to approximately 24 months)
- Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)(Up to approximately 24 months)
- Percentage of Participants That Experience at Least 1 Adverse Event(Up to approximately 27 months)
- Percentage of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 24 months)
研究者
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