UMIN-CTR Clinical Trial

Basic information
Public title	J-REGISTER: Japanese REal-world data for treatment of afatinib (GIotrif) in first-line setting and Subsequent Therapies for patients with advanced EGFR mutation-positive lung adenocarcinoma
Acronym	Non-interventional study for real-world data of afatinib treatment in first-line setting and of subsequent therapies for patients with advanced EGFR mutation-positive lung adenocarcinoma
Scientific Title	J-REGISTER: Japanese REal-world data for treatment of afatinib (GIotrif) in first-line setting and Subsequent Therapies for patients with advanced EGFR mutation-positive lung adenocarcinoma
Scientific Title:Acronym	Non-interventional study for real-world data of afatinib treatment in first-line setting and of subsequent therapies for patients with advanced EGFR mutation-positive lung adenocarcinoma
Region	Japan

Condition
Condition	lung adenocarcinoma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Determination of time on treatment (TOT) related to afatinib treatment as first-line therapy in patients with EGFR mutation-positive NSCLC.
Basic objectives2	Others
Basic objectives -Others	Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	TOT with afatinib in TOT1
Key secondary outcomes

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	All patients will be consecutively included from each study site, if all the following criteria are present: 1.Patients with EGFR mutation-positive advanced NSCLC 2.Patients who were/are treated with afatinib in the first-line setting at least 20 months* prior to data entry 3.Patients 20 years of age or older at the time of consent 4.Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethics Committee [EC] / Institutional Review Board [IRB] at each site should be followed) *Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.
Key exclusion criteria	Patient will not be included if any of the following criteria are present: 1.Any contraindication to afatinib as specified in the label of Giotrif 2.Patients treated with afatinib within an interventional trial 3.Patients with active brain metastases at start of afatinib treatment* * Patients with non-active brain metastases (asymptomatic state) are eligible.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Mizushima
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Division name	Medicine Division
Zip code	141-6017
Address	2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL	03-6417-2043
Email	masaya.mizushima@boehringer-ingelheim.com

Public contact
Name of contact person	1st name Masaya Middle name Last name Mizushima
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Division name	Medicine Division
Zip code	141-6017
Address	2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL	03-6417-2043
Homepage URL
Email	masaya.mizushima@boehringer-ingelheim.com

Sponsor
Institute	Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd.
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	Hyogo Prefectural Amagasaki General Medical Center Ethics Review Committeee
Address	2-17-77 Higashinanba-chou, Amagasaki-shi, Hyogo, Japan
Tel	06-6480-7000
Email	pbionoek3128891@gmail.com

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 04 Month 28 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 09 Month 04 Day
Date of IRB	2020 Year 12 Month 09 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The primary outcome of this study is TOT with afatinib in TOT1. This will be assessed as the time from the start of afatinib (Giotrif) as first-line treatment until the end of afatinib treatment or death date by any cause.

Management information
Registered date	2021 Year 04 Month 28 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050222