EUCTR2017-000920-81-HU进行中（未招募）1 期
A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON). - POSEIDO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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. Histologically or cytologically documented Stage IV NSCLC.
- •3. Confirmed tumor PD-L1 status prior to randomization.
- •4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.
- •5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
- •6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •7. No prior exposure to immune-mediated therapy, 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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
- •2. Active or prior documented autoimmune or inflammatory disorders.
- •3. Spinal cord compression.
- •4. Brain metastases unless the patient’s condition is stable and off steroids.
- •5. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
研究者
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