Unique ID issued by UMIN | UMIN000044071 |
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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 |
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
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
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
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
Japan |
lung adenocarcinoma
Pneumology |
Malignancy
YES
Determination of time on treatment (TOT) related to afatinib treatment as first-line therapy in patients with EGFR mutation-positive NSCLC.
Others
Not applicable
TOT with afatinib in TOT1
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
1000
1st name | Masaya |
Middle name | |
Last name | Mizushima |
Nippon Boehringer Ingelheim Co., Ltd.
Medicine Division
141-6017
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
03-6417-2043
masaya.mizushima@boehringer-ingelheim.com
1st name | Masaya |
Middle name | |
Last name | Mizushima |
Nippon Boehringer Ingelheim Co., Ltd.
Medicine Division
141-6017
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
03-6417-2043
masaya.mizushima@boehringer-ingelheim.com
Nippon Boehringer Ingelheim Co., Ltd.
Nippon Boehringer Ingelheim Co., Ltd.
Profit organization
Hyogo Prefectural Amagasaki General Medical Center Ethics Review Committeee
2-17-77 Higashinanba-chou, Amagasaki-shi, Hyogo, Japan
06-6480-7000
pbionoek3128891@gmail.com
NO
2021 | Year | 04 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 09 | Month | 04 | Day |
2020 | Year | 12 | Month | 09 | Day |
2021 | Year | 04 | Month | 01 | Day |
2023 | Year | 01 | Month | 31 | Day |
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.
2021 | Year | 04 | Month | 28 | Day |
2022 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050222
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