EUCTR2014-000531-17-IT进行中（未招募）1 期
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with EGFRm+/T790M+, Locally Advanced or Metastatic NSCLC who have Progressed Following Prior Therapy with an Approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent. - AURA-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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
- •Locally advanced/metastatic NSCLC.
- •Radiological documentation of disease progression following 1st line EGFR TKI treatment or following minimum prior therapy with an EGFR TKI and platinum-containing doublet chemotherapy.
- •Confirmation the tumour harbours EGFR and T790 mutation.
- •WHO status 0-1; min life expectancy of 12 weeks.
- •At least one measurable lesion at baseline by CT/MRI.
- •Females of child-bearing potential using contraception; negative pregnancy test.
- •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 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •Treatment with an EGFR-TKI within 8 days of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with AZD9291 (or 3rd generation TKIs); major surgery within 4 weeks; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks; current treatment with potent inhibitors of CYP2C8 and potent inhibitors/inducers of CYP3A4.
- •Unresolved toxicities from prior therapy.
- •Unstable spinal cord compression/brain metastases.
- •Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
- •Refractory nausea/vomiting, chronic gastrointestinal diseases or bowel resection.
- •Cardiac disease.
- •Past history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- •Inadequate bone marrow reserve or organ function.
研究者
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