NL-OMON45051已完成2 期
A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH PD L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER - GO28754 (BIRCH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
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 99（—）
入选标准
- •* Histologically or cytologically documented Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC ;* PD-L1-positive status as determined by an IHC assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory;* ECOG performance status of 0 or 1;* Life expectancy * 12 weeks;* Measurable disease, as defined by RECIST v1.1 ;* For female patients of childbearing potential and male patients with partners of
- •childbearing potential, agreement (by patient and/or partner) to use a highly
- •effective form(s) of contraception
排除标准
- •* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment;* Known CNS disease, including treated brain metastases;* Leptomeningeal disease;* History of auto-immune disease
研究者
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