EUCTR2014-000594-39-FR进行中（未招募）1 期
A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene (AURA3) - AURA3
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 610
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
- •- Subjects with histologically- or cytologically-documented NSCLC.
- •- Locally advanced or metastatic NSCLC.
- •- Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment.
- •- Eligible to receive treatment with the selected doublet-chemotherapy.
- •- Confirmation of EGFR mutation.
- •- Central confirmation of T790M+ mutation status.
- •- World Health Organisation (WHO) performance status 0-1.
- •- At least one lesion, not previously irradiated.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 210
排除标准
- •- Treatment with more than one prior line of treatment for advanced NSCLC.
- •- Treatment with an approved EGFR-TKI (eg, erlotinib, gefitinib, afatinib) within 8 days or approximately 5 x half-life of the first dose of study treatment.
- •- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- •- Previous treatment with an unapproved EGFR-TKI.
研究者
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