Assessment of Real-World Outcomes Associated with Afatinib (Gilotrif) Use in Patients with Solid Tumors Harboring NRG1 Gene Fusions (Afatinib (Gilotrif) Use in Solid Tumors Harboring)

Study identification

• EU PAS number:
  EUPAS43164
• Study ID:
  43431
• Official title and acronym:
  Assessment of Real-World Outcomes Associated with Afatinib (Gilotrif) Use in Patients with Solid Tumors Harboring NRG1 Gene Fusions (Afatinib (Gilotrif) Use in Solid Tumors Harboring)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Obtaining real-world data describing the real-world outcomes associated with afatinib in patients with NRG1 fusion-positive solid tumors is valuable, and such data may be used to explore potential use of afatinib in other indications through label expansion requests to the U.S. Food and Drug Administration (FDA) and other agencies.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 13 centres are involved in the study

Networks

Cardinal Health Oncology Provider Extended Network (OPEN)

Study timelines

Date when funding contract was signed

Planned:13/12/2019

Actual:13/12/2019

Study start date

Planned:15/10/2020

Actual:15/10/2020

Date of final study report

Planned:17/09/2021

Actual:17/09/2021

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