NL-OMON42560已完成2 期
Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations - ETOP 7-14 NICHE
European Thoracic Oncology Platform (ETOP)0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically or cytologically confirmed, non-predominant squamous subtype, stage IIIB (non amenable to curative-intent multimodal treatment) or IV NSCLC, according to 7th TNM classification
- •Tumour is platinum-refractory
- •Measurable or evaluable disease (according to RECIST 1.1 criteria)
- •Locally documented HER2 mutation
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Life expectancy >3 months
- •Adequate haematological, renal and hepatic function
- •Effective contraception, no pregnancy
排除标准
- •Mixed small-cell and non-small-cell histologic features
- •Uncontrolled lepto-meningeal metastatic disease
- •Previous treatment with HER2 targeted antibody or tyrosine kinase inhibitor
- •Any previous (in the past 3 years) or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast
- •History or presence of clinically relevant cardiovascular abnormalities
- •Other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient*s capacity to participate in the trial
- •Interstitial lung disease or pulmonary fibrosis
- •Any concurrent systemic anticancer therapy
研究者
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已完成
2 期
Afatinib in NSCLC With HER2 MutationNSCLCNCT02369484ETOP IBCSG Partners Foundation13
招募中
不适用
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