jRCT2080223013已完成3 期
A Phase 3 Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Parallel Assignment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
入选标准
- •Documented evidence of Stage IV NSCLC
- •No sensitizing EGFR mutation or ALK rearrangement
- •No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
- •World Health Organization (WHO) Performance Status of 0 or 1
排除标准
- •Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
- •Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
- •Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
- •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]
结局指标
主要结局
-
efficacy confirmatory pharmacogenomics -
次要结局
未报告次要终点
研究者
研究点 (1)
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