CTIS2023-503868-16-00招募中1 期
A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination with Atezolizumab Compared with Atezolizumab as Maintenance Therapy in Participants with Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Carboplatin, Etoposide and Atezolizumab - GO43104
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 658
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 ES-SCLC (per the VALG staging system), Adequate hematologic and end-organ function, ECOG PS 0 or 1, No prior systemic treatment for ES-SCLC, Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy, Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade 1 or better
排除标准
- •Presence or history of CNS metastases, Planned consolidative chest radiation, Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures, Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin, History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, Disease progression following induction treatment
研究者
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