EUCTR2015-003715-38-GB进行中（未招募）1 期
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination with Tremelimumab in Subjects with Advanced Non-small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 446
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Age = 18 years
- •2. Histologically confirmed locally advanced or metastatic squamous or nonsquamous NSCLC
- •3. ECOG performance status of 0 or 1
- •4. At least 1 measurable lesion according to RECIST Version 1.1
- •5. At least 1 lesion amenable to biopsy at screening
- •6. Adequate organ and marrow function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 147
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 299
排除标准
- •1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
- •2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug
- •3. Active or prior documented autoimmune disease within the last 2 years
- •4. Major surgical procedure within 28 days prior to the first dose of study drug
研究者
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