EUCTR2014-005364-14-IT进行中（未招募）1 期
Phase II trial of Afatinib as induction treatment in patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC) with EGFR-activating mutations. - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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 histologically or cytologically confirmed IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 IIIa NSCLC
- •Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution’s testing methodology.
- •male or female patients age =18 years
- •Adequate organ function, defined as all of the following:
- •Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
- •Platelet count >75,000/mm3
- •Serum creatinine < 1.5 times of the upper limit of normal
- •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).
- •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).
- •ECOG score between 0 - 1
- •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.
- •Patients who have not previously received radiotherapy, chemotherapy or target treatments for their disease and are suitable for surgery
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Patients with metastatic or advanced lung cancer not suitable for surgery are excluded.
- •Patients that had received previous therapy for lung cancer (es. EGFR tyrosine kinase inhibitor (TKI), chemotherapy, radiotherapy)
- •Patients are excluded if they had another cancer diagnosis in the last 5 years excepted adeguately treated non melanoma skin cancer or in situ cervical cancer
- •major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
- •known hypersensitivity to afatinib (Giotrif®) or any of its excipients
- •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.
- •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 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential ; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol
- •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
- •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
- •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.
- •Knowed 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.
研究者
相似试验
已完成
2 期
Phase II Study of First-Line Afatinib in Patients Aged 75 or Older With Advanced Lung Adenocarcinoma With EGFR MutationsElderly patients with NSCLC harboring sensitive EGFR mutationJPRN-UMIN000015834Osaka Lung Cancer Study Group38
Unknown
2 期
Phase II open label trial for Inflammatory Breast Cancer patients with Afatinib and/or Vinorelbine.CTRI/2012/01/002392Boehringer Ingelheim India Pvt Ltd40
进行中（未招募）
不适用
An unblinded clinical trial of afatinib with or without vinorelbine chemotherapy for the treatment of a subtype of Inflammatory Breast CancerEUCTR2010-024454-10-GBBoehringer Ingelheim30
进行中（未招募）
2 期
YAMATO studylung cancerJPRN-jRCTs031200021Yoshioka Hiroshige110
进行中（未招募）
1 期
Afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype non-small cell lung cancer and colorectal cancerPatients with histological or cytological proof of advanced KRAS mutant and PIK3CA wildtype non small cell lung cancer (NSCLC) and colorectal cancer (CRC). In part B: for which first-line treatment failed.MedDRA version: 21.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029518 Term: Non-small cell lung cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001855-22-NLetherlands Cancer Institute- Antoni van Leeuwenhoek Hospital140