UMIN-CTR Clinical Trial

Basic information
Public title	An exploratoly study to evaluate biomarkers in cell free DNA of "Sequential therapy from afatinib to osimertinib for EGFR mutant non small cell lung cancer: a multicenter prospective observational study (Gio Tag Japan)".
Acronym	Biomarker study in cell free DNA of Gio-Tag Japan.
Scientific Title	An exploratoly study to evaluate biomarkers in cell free DNA of "Sequential therapy from afatinib to osimertinib for EGFR mutant non small cell lung cancer: a multicenter prospective observational study (Gio Tag Japan)".
Scientific Title:Acronym	Biomarker study in cell free DNA of Gio-Tag Japan.
Region	Japan

Condition
Condition	non-small cell lung cancer(EGFR mutation positive)
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To explore biomarkers using Cell free DNA (cfDNA) that predict the efficacy of sequential therapy from afatinib to osimertinib
Basic objectives2	Others
Basic objectives -Others	Biomarker research
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the correlation between the presence or absence of compound mutations in cfDNA and the duration of treatment with sequential therapy from afatinib to osimertinib
Key secondary outcomes	1) To evaluate the correlation between the presence or absence of compound mutations in cfDNA at resistance to afatinib and the duration of afatinib treatment 2) To evaluate the correlation between the presence or absence of compound mutations in cfDNA before afatinib treatment and the duration of osimertinib treatment 3) To evaluate the correlation between the presence or absence of compound mutations in cfDNA and overall survival 4) To evaluate changes in compound mutations before afatinib and at resistance

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients enrolled in Gio-Tag Japan study
Key exclusion criteria	None
Target sample size	93

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Katakami
Organization	Takarazuka City Hospital
Division name	Department of Medical Oncology
Zip code	665-0827
Address	5-1, 4 chome, Kohama, Takarazuka
TEL	0797-87-1161
Email	nkatakami1954@gmail.com

Public contact
Name of contact person	1st name Hideharu Middle name Last name Kimura
Organization	Kanazawa University Hospital
Division name	Respiratory Medicine
Zip code	920-8641
Address	Takara-machi 13-1, Kanazawa, Ishikawa
TEL	076-265-2000
Homepage URL
Email	hkimura3625@staff.kanazawa-u.ac.jp

Sponsor
Institute	HANSHIN Oncology Group
Institute
Department

Funding Source
Organization	Boehringer Ingelheim
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Takarazuka City Hospital
Address	5-1, 4 chome, Kohama, Takarazuka
Tel	0797-87-1161
Email	klog@jcom.zaq.ne.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

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 03 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	Enrolling by invitation
Date of protocol fixation	2020 Year 12 Month 08 Day
Date of IRB	2020 Year 12 Month 24 Day
Anticipated trial start date	2020 Year 12 Month 24 Day
Last follow-up date	2024 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Biomarker study of prospective observational study

Management information
Registered date	2021 Year 02 Month 03 Day
Last modified on	2021 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049333