Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma
NCT ID: NCT04795245
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
805 participants
OBSERVATIONAL
2021-08-26
2023-10-16
Brief Summary
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The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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patients treated with afatinib
afatinib
afatinib
Interventions
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afatinib
afatinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who were/are treated with afatinib in the first-line setting at least 20 months\* prior to data entry
* Patients 20 years of age or older at the time of consent
* Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic 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
* Patients treated with afatinib within an interventional trial
* Patients with active brain metastases at start of afatinib treatment\* \* Patients with non-active brain metastases (asymptomatic state) are eligible.
20 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, , Japan
Countries
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References
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Yamaguchi T, Daga H, Tanaka H, Kijima T, Mizushima M. J-REGISTER: real-world study of Japanese patients with EGFR mutation-positive NSCLC treated with first-line afatinib. Future Oncol. 2025 Jul;21(16):2039-2052. doi: 10.1080/14796694.2025.2514423. Epub 2025 Jun 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1200-0322
Identifier Type: -
Identifier Source: org_study_id