CTIS2023-503376-24-00招募中1 期
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% - MK-2870-007
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 625
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
- •Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (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, 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, Has Grade =2 peripheral neuropathy, Concurrent active Hepatitis B and Hepatitis C virus infection, 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, 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 within 6 months of start of study intervention
研究者
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