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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044071

Enrollment

1000

Registered

2021-04-28

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung adenocarcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
TOT with afatinib in TOT1	—

Countries

Japan

Contacts

Public ContactMasaya Mizushima

Nippon Boehringer Ingelheim Co., Ltd. Medicine Division

masaya.mizushima@boehringer-ingelheim.com03-6417-2043

Outcome results