EUCTR2015-003390-15-FR进行中（未招募）1 期
Phase II study evaluating the combination of cetuximab with afatinib as first-line treatment for patients with EGFR mutated Non Small Cell Lung Cancer - ACE : Afatinib plus Cetuximab for EGFR Mutant Lung Cancers
IFCT0 个研究点目标入组 170 人开始时间: 2015年12月14日最近更新:
适应症
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
- 170
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
- •Stage III or IV NSCLC, non irradiable non operable
- •Non squamous NSCLC histologically or cytologically confirmed
- •No previous treatment of NSCLC
- •EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q orS768I mutations or exon 19 insertion)
- •Presence of at least one lesion that can be measured
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Symptomatic brain metastasis or requiring immediate radiotherapy
- •T790M mutation or exon 20 insertion
- •Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
- •Interstitial pneumopathy
研究者
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