EUCTR2016-002029-12-NL进行中（未招募）1 期
A randomised phase II trial of osimertinib and bevacizumab versus osimertinib alone as second-line treatment in stage IIIb-IVb NSCLC with confirmed EGFRm and T790M - BOOSTER
ETOP (European Thoracic Oncology Platform)0 个研究点目标入组 154 人开始时间: 2017年5月24日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
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
- •NSCLC, stage IIIb/IIIc (not amenable to radical therapy) or IVa/IVb according to 8th TNM classification, after progression following prior EGFR TKI (erlotinib, gefitinib, dacomitinib or afatinib) therapy as the most recent treatment regimen.
- •Pathological diagnosis of predominantly non-squamous NSCLC.
- •Maximum of one line of previous platinum based chemotherapy.
- •Histological or cytological confirmation of EGFRm (exon19 deletion or exon 21 L858R).
- •Locally confirmed T790M mutation determined from biopsy (preferred) or on circulating tumour DNA, documented in tissue, plasma or serum after disease progression on the most recent EGFR TKI regimen.
- •Plasma, serum, and tumour (preferred) tissue or cytology (if biopsy was taken and FFPE tumor material is not yet fully depleted) after disease progression on the most recent EGFR TKI treatment available for central confirmation of T790M.
- •Measurable or evaluable disease
- •Adequate haematological, renal and liver function
- •Performance status 0-2
- •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 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 154
排除标准
- •Patients with mixed NSCLC with predominantly squamous cell cancer, or with any small cell lung cancer (SCLC) component.
- •Symptomatic or active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
- •Previous treatment with osimertinib and/or bevacizumab
- •Patients currently receiving medications or herbal supplements known to be potent CYP3A4 inducers
- •Any unresolved toxicities from prior therapy greater than CTCAE V 4.0 grade 1
研究者
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