NIPH Clinical Trials Search

UMIN ID: UMIN000013806

Registered date:07/05/2014

A biomarker analysis of plasma and tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadenocarcinoma of the lung
Date of first enrollment2014/05/07
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Afatinib40mg/day:oral daily


Primary OutcomeA detection of a biomarker about afatinib tolerance
Secondary Outcome1.Progression Free Survival 2.Time to Systemic PD 3.Response rate 4.Safety

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Patients with active double cancer 2)Patients with interstitial pneumonia confirmed by chest CT. 3)Patient with neurologic symptom caused by non-treated brain metastasis 4) Patients with either superior vena cava syndrome, pericardial effusion, pleural effusion or ascites >= Grade 3. 5) Patients with an operation with the systemic anesthesia within 28 days before enrollment. 6)Patient with a palliative radiotherapy for the metastatic focus except the chest (including gamma knife treatment for the brain metastatic focus) within 7 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0). 7) Patient with a radiation exposure to the chest or mediastinum within 14 days before enrollment (the irradiation of the same day 2 weeks ago is permitted as enrollment day as day0). 8)Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study. 9) Patient with positive HBs antigen. 10) Patient having a serious infection to need systemic treatment. 11)Any other patients who are regarded as unsuitable for this study by the investigators.

Related Information


public contact
Name Eiji Iwama
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan, 812-8582 Japan
Telephone 092-642-5378
Affiliation Graduate School of Medical Sciences, Kyushu University Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology
scientific contact
Name Isamu Okamoto
Address 3-1-1 Maidashi ,Higashi-ku,Fukuoka, Japan
Telephone 092-642-5378
Affiliation Kyushu University Hospital Research Institute for Disease of the Chest / Center for Clinical and Translational Research