A regulatory requirement post-marketing surveillance study to monitor the safety and efficacy of GIOTRIF®(afatinib dimaleate, 20mg, 30mg, 40mg, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation(s) (GIOTRIF rPMS in Korean patients with NSCLC)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20368
• EU PAS number:
  EUPAS9364
• Study ID:
  20368
• Official title and acronym:
  A regulatory requirement post-marketing surveillance study to monitor the safety and efficacy of GIOTRIF®(afatinib dimaleate, 20mg, 30mg, 40mg, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation(s) (GIOTRIF rPMS in Korean patients with NSCLC)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To monitor the safety profile and efficacy of GIOTRIF®(afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 01/10/2014

Actual: 06/11/2014

Study start date

Planned: 01/11/2014

Actual: 11/11/2014

Data analysis start date

Planned: 30/11/2018

Date of final study report

Planned: 28/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable