Paclitaxel-trastuzumab in EGFR-mutated NSCLC patients after progression on TKI-treatment; a pilot study - HER2 in NSCLC

未提供0 个研究点目标入组 16 人开始时间: 2014年10月8日最近更新: 2018年6月5日

适应症

试验速览

暂无简介。

•Histologically confirmed stage IV non-squamous NSCLC patients.
•Patients must have been detected with an activating EGFR mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).
•Rebiopsy after having acquired resistance to TKI-treatment must have been performed and HER2-overexpression (positive immunohistochemistry staining) must have been detected.
•There must be at least one measurable disease site, according to RECIST 1.1 criteria.
•WHO performance status 0-2.
•Willing and able to comply with the study prescriptions.
•18 years or older.
•Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.
•Ability to give written informed consent before patient registration.
•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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•No uncontrolled infectious disease.
•No other active malignancy.
•No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
•No treatment with investigational drugs.
•No known hypersensitivity to trastuzumab-paclitaxel
•No symptomatic brain metastases.
•History of coronary artery disease, NYHA class III or IV and Left Ventricular Ejection Fraction (LVEF) of <45%.

发起方

未提供