EUCTR2015-002197-21-BG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 Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) (NEPTUNE). - NEPTUNE
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
- 1,330
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
- •1. Aged at least 18 years.
- •2. Documented evidence of Stage IV NSCLC.
- •3. No activating EGFR mutation or ALK rearrangement.
- •4. No prior chemotherapy or any other systemic therapy for advanced or metastatic NSCLC.
- •5. Confirmed tumor PD-L1 status.
- •6. World Health Organization (WHO) Performance Status of 0 or 1.
- •7. No Prior exposure to IMT, including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or anti PDL2 antibodies, excluding therapeutic anticancer vaccines
- •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 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 480
排除标准
- •1. Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant
- •2. Brain metastases or spinal cord compression unless the patient is stable
- •(asymptomatic; no evidence of new or emerging brain metastases) and off steroids
- •for at least 14 days prior to start of study treatment.
- •3. Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)
研究者
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