EUCTR2015-001279-39-FR进行中（未招募）1 期
A Phase III 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) (MYSTIC) - MYSTIC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
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
- 性别
- All
入选标准
- •Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria:
- •Aged at least 18 years
- •Documented evidence of Stage IV NSCLC
- •No activating EGFR mutation or ALK rearrangement
- •No prior chemotherapy or any other systemic therapy for advanced/metastatic NSCLC
- •World Health Organization (WHO) Performance Status of 0 or 1
- •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 455
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 220
排除标准
- •- Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •Mixed small-cell lung cancer and NSCLC histology or not otherwise specified (NSCLC NOS)
- •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 inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
研究者
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