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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013806
Receipt No. R000016105
Scientific Title A biomarker analysis of plasma and tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung.
Date of disclosure of the study information 2014/05/07
Last modified on 2018/04/27

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Basic information
Public title A biomarker analysis of plasma and
tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung.
Acronym Afatinib I I S
Scientific Title A biomarker analysis of plasma and
tumor DNA in afatinib-treatedpatients with EGFR mutation-positive advanced adenocarcinoma of the lung.
Scientific Title:Acronym Afatinib I I S
Region
Japan

Condition
Condition adenocarcinoma of the lung
Classification by specialty
Pneumology Laboratory medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 1.To investigate gene mutation and expression level as a biomarker related with the resistance to afatinib in EGFR gene mutation-positive pulmonary adenocarcinoma using a tumor tissue and a peripheral circulatory free DNA.
2.To investigate clinical benefit of peripheral circulatory free DNA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A detection of a biomarker about afatinib tolerance
Key secondary outcomes 1.Progression Free Survival
2.Time to Systemic PD
3.Response rate
4.Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Afatinib40mg/day:oral daily
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with pulmonary adenocarcinoma with a histological diagnosis and cytodiagnosis.
2) Patients with EGFR gene mutation(exon 19 deletion mutation or L858R mutation in exon 21)within 1 year before enrollment.
3)Patients whose tumor specimen can be submitted.
4)Patients with pathologically confirmed diagnosis of stage IIIB(not amenable for curative intent local radiotherapy)/IV (recurrent or metastatic)adenocarcinoma of the lung.
5) Patients with no treatment of EGFR-TKI.
6) Patients that 2 wks pass from the last dosage of the anticancer drug in the case of systemic chemotherapy.
7) Patients with more than 20 years old on the enrollment day.
8) Patients with ECOG PS 0 or 1.
9) Patients harboring a more than one measurable lesion.
10) Patient whose latest level of laboratory test within 14 days before enrollment meets all following categories (the examination of the same date two weeks before the registration day is permitted).
(1) Neutrophil >= 1,500/mm3
(2) Hemoglobin >= 9.0 g/dL(A blood transfusion is not enforced within 14 days of the examination before enrollment)
(3) Platelet >= 10X104/ mm3
(4) Total bilirubin <= 1.5 mg/dl
(5) AST(GOT)<= 100
(6) ALT(GPT)<= 100
(7) Serum creatinine <= 2.0 mg/dl
(8) SpO2 >= 92%. In case of SpO2 < 92%, PaO2 >= 60 torr is eligible.
11) Patients providing written informed consent.
Key exclusion criteria 1) 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.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isamu Okamoto
Organization Kyushu University Hospital
Division name Research Institute for Disease of the Chest / Center for Clinical and Translational Research
Zip code
Address 3-1-1 Maidashi ,Higashi-ku,Fukuoka,
TEL 092-642-5378
Email okamotoi@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Iwama
Organization Graduate School of Medical Sciences, Kyushu University
Division name Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan, 812-8582
TEL 092-642-5378
Homepage URL
Email iwama@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 07 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 25 Day
Last modified on
2018 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016105

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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