UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Acronym	Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Scientific Title	Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Scientific Title:Acronym	Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factor of resistance to afatinib in EGFR gene mutation positive NSCLC. To investigate the frequency of T790M mutation and concordance rate between blood and tumor tissue at PD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of T790M mutation and concordance rate between blood and tumor tissue at PD
Key secondary outcomes	1) PFS 2) ORR 3) TTF 4) OS 5) Safety 6) The correlation between blood concentration of afatinib and 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	Afatinib 40mg/day
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 NSCLC with a histological diagnosis or cytodiagnosis 2) Patients with EGFR gene mutation 3) Patients with unresectable advanced case 4) Patients that 14 days pass from the last dosage of systemic chemotherapy 5) Patients with more than 20 years old 6) Patients with ECOG PS 0,1,2 7) Patients harboring a more than one measurable lesion 8) Patients that expected survival time is more than 2 months 9) Patients with adequate organ function Neutrophil >= 1500/mm3 Platelet >= 100,000/mm3 Hemoglobin >= 8.0g/dl AST,ALT <=2.5 x ULN Total bilirubin <= 2mg/dl 10) Patients providing written informed consent
Key exclusion criteria	1) Patients with interstitial pneumonitis or pulmonary fibrosis 2) Patients with serious infection 3) Patients with unsteady angina or cardiac infarction 4) Patients with severe complication 5) Patients with active double cancer 6) Patients requiring medication influenced P glycoprotein 7) Patients with history of dosage afatinib 8) Patients with contraindication against afatinib 9) Patients with history of serious hypersensitivity or allergy 10) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby 11) Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study 12) 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 Keiko Middle name Last name Mizuno
Organization	Kagoshima University Hospital
Division name	Department of Pulmonary medicine
Zip code	890-8520
Address	8-35-1, Sakuragaoka, Kagoshima-city
TEL	99-275-5111
Email	keim@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Mizuno
Organization	Kagoshima University Hospital
Division name	Department of Pulmonary medicine
Zip code	890-8520
Address	8-35-1, Sakuragaoka, Kagoshima-city
TEL	099-275-5111
Homepage URL
Email	keim@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Hospital
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	Ethics Committee on Clinical Research, Kagoshima University Hospital
Address	8-35-1, Sakuragaoka, Kagoshima-city
Tel	099-275-5111
Email	kufsyomu@kuas.kagoshima-u.ac.jp

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	鹿児島大学病院(鹿児島県） 川内市医師会立市民病院(鹿児島県） 南九州病院(鹿児島県） 鹿児島市立病院(鹿児島県） 鹿児島厚生連病院(鹿児島県） 今給黎総合病院(鹿児島県） 南風病院(鹿児島県） 鹿児島県立北薩病院(鹿児島県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	26
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	2017 Year 02 Month 24 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 09 Month 15 Day
Last follow-up date	2020 Year 08 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	2018 Year 03 Month 22 Day
Last modified on	2020 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036359