EUCTR2018-001375-21-NL进行中（未招募）1 期
A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non Small-Cell Lung Cancer (NSCLC) - Pearl
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
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
- •-Aged at least 18 years
- •- Documented evidence of Stage IV NSCLC
- •- No sensitizing EGFR mutation or ALK rearrangement
- •- PD-L1 positive expression status, prior to randomization, defined as PD-L1 high membrane expression in tumoral tissue with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory
- •- No prior chemotherapy or any other systemic therapy for advanced or 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 430
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 220
排除标准
- •Prior chemotherapy or any other systemic therapy for advanced NSCLC
- •Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
- •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
- •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
- •Active infection
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
研究者
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