CTIS2023-504910-31-00招募中1 期
A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants with EGFR-mutated, Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors - MK-2870-009
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 615
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 advanced-stage nonsquamous non-small cell lung cancer (NSCLC)., Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade <1 or baseline., Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load., Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable., Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy., Life expectancy of at least 3 months.
排除标准
- •Predominantly squamous cell histology NSCLC., Known active central nervous system metastases and/or carcinomatous meningitis., Active infection requiring systemic therapy., History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Concurrent active HBV and HCV infection., History of allogeneic tissue/solid organ transplant., Participants who have not adequately recovered from major surgery or have ongoing surgical complications., History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years., 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., Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease., Uncontrolled, or significant cardiovascular disease or cerebrovascular disease., 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 is allowed., Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
研究者
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