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)

Study identification

• EU PAS number:
  EUPAS40322
• Study ID:
  40323
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC). ; 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned:20/12/2019

Actual:20/12/2019

Study start date

Planned:01/04/2021

Actual:26/08/2021

Data analysis start date

Planned:31/10/2022

Date of final study report

Planned:31/01/2023

Actual:24/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

NCT04795245
1200-0322

https://www.clinicaltrials.gov/ct2/show/NCT04795245?term=afatinib&draw=2&rank=2