Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S. (Afatinib post IO)

Study identification

• EU PAS number:
  EUPAS36813
• Study ID:
  36814
• Official title and acronym:
  Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S. (Afatinib post IO)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  1) To describe the demographic and clinical characteristics of patients who, after failure of 1L pembrolizumab in combination with chemotherapy, received either afatinib in 2L or chemotherapy in 2L (single-agent, doublet, and by specific regimen). 2) To describe time on treatment for patients who, after failure of 1L pembrolizumab in combination with chemotherapy, received either afatinib in 2L or chemotherapy in 2L (single-agent, doublet, and by specific regimen).3) To describe the incidence of severe (grade 3 or higher) irAEs of specific interest (including pneumonitis, colitis, hepatitis, interstitial lung disease, higher indeterminate pulmonary events, death, or discontinuation of therapy due to toxicity) during 2L treatment with afatinib or chemotherapy following failure of 1L pembrolizumab in combination with chemotherapy.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:29/05/2018

Actual:29/05/2019

Study start date

Planned:08/05/2020

Actual:08/05/2020

Date of final study report

Planned:18/08/2020

Actual:18/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheilm

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

1200-0325