UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044071
Receipt number R000050222
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
Date of disclosure of the study information 2021/04/28
Last modified on 2022/03/01 20:50:12

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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 or person

Institute

Nippon Boehringer Ingelheim Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name