PER-060-15已完成未知
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 3 STUDY OF NIVOLUMAB, NIVOLUMAB IN COMBINATION WITH IPILIMUMAB, OR PLACEBO AS MAINTENANCE THERAPY IN SUBJECTS WITH EXTENSIVE-STAGE DISEASE SMALL CELL LUNG CANCER (ED-SCLC) AFTER COMPLETION OF PLATINUM-BASED FIRST LINE CHEMOTHERAPY
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 2
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
- •1)Subjects with SCLC documented by histology or cytology.
- •2)Initial diagnosis with extensive stage disease (Stage IV).
- •3) ECOG Performance Status 0 or 1.
- •4)Subjects must have received 4 cycles of platinum-based first line chemotherapy and must have an ongoing response of complete response (CR), partial response (PR), or stable disease (SD) after completion of chemotherapy.
- •5) Randomized ≤ 7 weeks from the last dose of platinum-based first line chemotherapy.
- •6) A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation.
排除标准
- •1.Subjects with untreated central nervous system metastases are excluded
- •2.Subjects with active, known, or suspected autoimmune disease are excluded
- •3.All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
研究者
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