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:
  Planned

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

Data analysis start date

Planned:31/10/2022

Date of final study report

Planned:31/01/2023

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