NL-OMON55787已完成2 期
Trastuzumab-emtansine and osimertinib combination treatment to target HER2 bypass track resistance in EGFR mutation positive NSCLC - TRAEMOS
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 58 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
- 58
研究概览
简要总结
Trial ended prematurely
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 stage IV non-squamous NSCLC,
- •characterized by an activating EGFR mutation., -Progressive disease according
- •to RECIST 1.1 on first, second or third generation EGFR TKI and still receiving
- •the drug., -A rebiopsy after having acquired resistance to a first, second or
- •third generation TKI-treatment must have been performed and be:, a. Negative
- •for T790M in case of treatment with a first or second generation EGFR TKI.
- •After progression on a third generation EGFR TKI patients may either be
- •positive or negative for T790M., b. Positive for HER2-overexpression (positive
- •membranous immunohistochemistry staining IHC >=2+ (on a scale of 0-3) in >=10% of
- •the cells) must have been detected., -There must be at least one measurable
- •disease site, according to RECIST 1.1 criteria., -Absence of symptomatic brain
- •metastases. All patients will be scanned at baseline with a brain MRI.,
- •-Patients must be willing and able to comply with the protocol for the duration
- •of study including undergoing treatment and scheduled visits and examinations.,
- •-World Health Organization (WHO) performance status 0-2., -Patients must have a
- •life expectancy >=12 weeks., -Ability to give written informed consent before
- •patient registration., -Patients must be >=18 years of age., -Men and women of
- •child bearing potential should be willing to take adequate contraceptive
- •measures during the study and until three months after study drug
- •discontinuation.
排除标准
- •-Uncontrolled infectious disease., -Other active malignancy., -Major surgery
- •(excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in
- •the previous 4 weeks., -Known hypersensitivity to T-DM1 or osimertinib (or
- •drugs with a similar chemical structure or class) or any excipients of these
- •agents., -Previous treatment with a HER2 monoclonal antibody., -Clinically
- •significant cardiac disease or a Left Ventricular Ejection Fraction (LVEF) of
- •<40%., -Inadequate bone marrow reserve or organ function, as demonstrated by
- •any of the following laboratory values: Haematology: haemoglobin <5.6mmol/L,
- •absolute neutrophil count <1.5 x 10^9/L, platelet count <100 x 10^9/L.
- •Biochemistry: alanine aminotransferase, aspartate aminotransferase and
- •bilirubin <= 3x ULN, except in the case of liver metastases where these values
- •must be <= 5x ULN. Creatinine clearance <50 ml/min (measured or calculated by
- •Cockroft and Gault equation)., -Patients with symptomatic central nervous
- •system metastases who are neurologically unstable., -Refractory nausea and
- •vomiting, chronic gastrointestinal diseases, inability to swallow osimertinib
- •or previous significant bowel resection that would preclude adequate resorption
- •of osimertinib., -Patients on anticoagulant treatment will not be excluded, but
- •should be monitored closely during T-DM1 treatment., -Males and females of
- •reproductive potential who are not using an effective method of birth control
- •and females who are pregnant or breastfeeding or have a positive (serum)
- •pregnancy test prior to study entry., -Judgment by the investigator that the
- •patient should not participate in the study if the patient is unlikely to
- •comply with study procedures, restrictions and requirements.
研究者
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