Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in Combination with Chemotherapy for Treatment of Metastatic Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41158
• EU PAS number:
  EUPAS41157
• Study ID:
  41158
• Official title and acronym:
  Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in Combination with Chemotherapy for Treatment of Metastatic Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To describe the demographic and clinical characteristics, the time on treatment, and the incidence of severe (grade 3 or higher) immune-related AEs of specific interest in 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).
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 22/08/2019

Actual: 22/08/2019

Study start date

Planned: 13/01/2020

Actual: 08/05/2020

Date of interim report, if expected

Actual: 17/08/2020

Date of final study report

Planned: 26/02/2021

Actual: 22/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Initial protocol

BI-afatinib post IO NSCLC_NISed protocol final 1.9.20 clean (008)

Regulatory

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