GioTag: Real-world data study on sequential therapy with Gi(l)otrif®/ afatinib as first-line treatment followed by osimertinib in patients with EGFR mutation positive advanced non-small cell lung cancer

Study identification

• EU PAS number:
  EUPAS21037
• Study ID:
  30134
• Official title and acronym:
  GioTag: Real-world data study on sequential therapy with Gi(l)otrif®/ afatinib as first-line treatment followed by osimertinib in patients with EGFR mutation positive advanced non-small cell lung cancer
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Canada

  Germany

  Israel

  Italy

  Japan

  Singapore

  Slovenia

  Spain

  Taiwan

  United States
• Study description:
  The observational study is designed to determine the time on treatment of afatinib (Gi(l)otrif®) as first-line therapy in patients with EGFR mutation-positive NSCLC followed by osimertinib in case the T790M resistance mutation was developed in real-world setting and to collect data on osimertinib’s resistance mechanisms (when available) in order to provides insights on treatment sequence that could inform on the most beneficial treatment sequence in patients diagnosed with advanced EGFR mutation-positive NSCLC.
• Study status:
  Finalised

Research institutions and networks

Institutions

Maximilian Hochmair

Multiple centres: 45 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/05/2017

Actual: 02/05/2017

Study start date

Planned: 15/01/2018

Actual: 28/12/2017

Data analysis start date

Planned: 30/06/2018

Actual: 29/06/2018

Date of final study report

Planned: 30/09/2018

Actual: 26/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

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