EUCTR2014-005098-35-DE进行中（未招募）1 期
Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations - NICHE - afatinib in NSCLC with HER2 mutation
ETOP (European Thoracic Oncology Platform)0 个研究点目标入组 22 人开始时间: 2015年6月3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
- 22
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
- •- 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
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
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
相似试验
已完成
2 期
Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutationsadvanced non-small cell lung cancer1003866610029107NL-OMON42560European Thoracic Oncology Platform (ETOP)6
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Trial to evaluatie the ability of afatinib to control disease in patients with advanced non-small cell lung cancer harboring a specific gene mutation (change) in the human epidermal growth factor 2 (HER 2)Advanced stage NSCLC, harbouring HER2 exon 20 mutationsMedDRA version: 17.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005098-35-ESETOP (European Thoracic Oncology Platform)22
已完成
2 期
Afatinib in NSCLC With HER2 MutationNSCLCNCT02369484ETOP IBCSG Partners Foundation13
招募中
不适用
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