Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations - NICHE

ETOP (European Thoracic Oncology Platform)0 个研究点目标入组 22 人开始时间: 2015年4月14日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•- 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 2
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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

发起方

ETOP (European Thoracic Oncology Platform)