EUCTR2018-001521-97-NL进行中（未招募）1 期
Phase II single arm study of afatinib in combination with cetuximab in EGFR exon 20 insertion positive non-small-cell lung cancer
Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 37 人开始时间: 2018年7月12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）
- 入组人数
- 37
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
- •Pathologically or cytologically confirmed stage IV NSCLC, harboring an EGFR exon 20 insertion mutation.
- •18 years or older at time of study entry.
- •Life expectancy of at least three months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 1).
- •Measurable disease, according to RECIST 1.1.
- •At baseline adequate fresh or archived tissue from a histological biopsy or a cellblock obtained by fine needle aspiration of a tumor lesion that is not radiated prior to biopsy, must be available. Baseline tissue samples must be obtained after the last line of systemic therapy prior to study entry.
- •Adequate normal organ and marrow function as defined below:
- •Absolute leukocyte count = 3 x 109/L (> 3000 per mm3)
- •Platelet count = 75 x 109/L (>75,000 per mm3)
- •Aspartate amino transferase (AST) or alanine amino transferase (ALT) = 3 x institutional upper limit of normal unless liver metastases are present, in which case it must be = 5x ULN.
- •Serum creatinine CL>30 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
- •Women of child-bearing potential: these subjects must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective contraception, as defined in section 5.2.2, from 7 days prior to enrollment, throughout the treatment period and for seven months after completion of the treatment with cetuximab.
- •Males must agree to take appropriate precautions to avoid fathering a child from the first dose of study treatment through 3 months after the final administration of investigational drugs.
- •Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •Participation in another clinical study with an investigational product during the last 2 weeks.
- •Prior treatment with EGFR targeting antibodies (prior treatment with EGFR TKI’s is allowed).
- •Other active malignancy.
- •History of hypersensitivity to afatinib or cetuximab.
- •Major surgery (excluding diagnostic procedures e.g. mediastinoscopy or VATS biopsy) within 28 days of the start of study treatment.
- •Radiotherapy less than two weeks prior to the start of study treatment.
- •Symptomatic brain metastases.
- •Breast feeding
- •Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, myocardial infarction within 12 months prior to the study entry, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
- •Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety and anti-tumor activity of the test drugs.
研究者
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