EUCTR2017-004397-34-HU进行中（未招募）1 期
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently with Platinum-based Chemoradiation Therapy in Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III) (PACIFIC2) - PACIFIC2
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 390
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
- •- Subjects with histologically- or cytologically-documented NSCLC
- •- Locally advanced or unresectable (Stage III) NSCLC
- •- World Health Organisation (WHO) performance status 0-1
- •- At least one measurable lesion, not previously irradiated
- •- Must have a life expectancy of at least 12 weeks at randomization
- •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 234
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •- Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
- •- Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines.
- •- History of allogeneic organ transplantation
- •- Active or prior documented autoimmune or inflammatory disorders
- •- Uncontrolled intercurrent illness
- •- History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency
- •- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- •- Mixed small cell and NSCLC histology
- •- Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling
- •- Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
- •- Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving =20 Gy in total (V20) of more than 35% of lung volume.
研究者
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