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临床试验/EUCTR2009-017661-34-HU
EUCTR2009-017661-34-HU进行中（未招募）1 期

An open label trial of afatinib in treatment-naive (1st line) or chemotherapy pre-treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s)

Boehringer Ingelheim RCV GmbH & Co KG0 个研究点目标入组 500 人开始时间: 2013年4月12日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
500
研究概览入排标准研究者记录与标识符相似试验

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

  • •Patients with:
  • •1)locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
  • •2)Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution’s testing methodology.
  • •3)male or female patients age =18 years
  • •4)Adequate organ function, defined as all of the following:
  • •a.Left Ventricular Ejection Fraction (LVEF) >50% or within institution normal values
  • •b.Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
  • •c.Platelet count >75,000/mm3
  • •d.Serum creatinine ? 1.5 times of the upper limit of normal
  • •e.Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert’s syndrome total bilirubin must be <4 times institutional upper limit of normal).
  • •f.Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN).
  • •5)ECOG score between 0 - 2
  • •6)written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.
  • •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 350
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 150

排除标准

  • •Patients who or with:
  • •1)prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
  • •2)anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
  • •3)radiotherapy within 14 days prior to drug administration, except as follows:
  • •a.Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
  • •b.Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  • •4)major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
  • •5)known hypersensitivity to afatinib or any of its excipients (see Section 4.1.1)
  • •6)history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3 (Refer to Appendix 10.2), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
  • •7)are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential described in Section 4.2.3.
  • •8)are WOCBP childbearing potential (see Section 4.2.3) who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol
  • •9)any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the trial or interfere with the evaluation of safety for the trial drug
  • •10)previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
  • •11)requiring treatment with any of the prohibited concomitant medications listed in Section 4.2.2 that can not be stopped for the duration of trial participation
  • •12)known pre-existing interstitial lung disease
  • •13)presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn’s disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
  • •14)active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
  • •15)meningeal carcinomatosis
  • •16)symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of medication)

研究者

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