EUCTR2018-002885-38-NL进行中（未招募）1 期
Trastuzumab-emtansine and osimertinib combination treatment to target HER2 bypass track resistance in EGFR mutation positive NSCLC - TRAEMOS
Stichting Het Nederlands Kanker Instituut-Antoni van Leuewenhoek Ziekenhuis0 个研究点目标入组 58 人开始时间: 2018年8月1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
- 58
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
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.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
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
相似试验
已完成
2 期
Trastuzumab-emtansine and osimertinib combination treatment to target HER2 bypass track resistance in EGFR mutation positive NSCLClung cancernon-small cell lung cancerNL-OMON55787Antoni van Leeuwenhoek Ziekenhuis58
终止
2 期
T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLCCarcinoma, Non-Small-Cell LungNCT03784599The Netherlands Cancer Institute28
已完成
2 期
Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.HER2 positive metastatic breast cancerJPRN-UMIN000009296Setouchi Breast Project30
已完成
1 期
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast CancerMetastatic Breast CancerNCT02073916Jenny C. Chang, MD24
进行中（未招募）
1 期
A study in HER2-positive breast cancer that has spread to other organs or tissues and has not responded to a course of anti-cancer treatment and a study in HER2-positive inoperable gastric cancer or gastric cancer that has spread to other organs or tissues.HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer.MedDRA version: 19.0Level: PTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-001547-46-DEF. Hoffmann-La Roche Ltd.160