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 type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Afatininb after failure of IO
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Gilotrif
• Medical condition to be studied:
  Lung cancer metastatic

Population studied

• Short description of the study population:
  Providers will select patients meeting the study eligibility criteria as describe below. Providers will be asked to select eligible patients chronologically, starting with the first patient who first initiated 2L afatinib or chemotherapy on or after 06/01/2018 but at least 3 months prior to data collection, and then randomly from that point forward until they have submitted their maximum number of patients or no further patients are evaluable.; Inclusion Criteria:; 1. Diagnosis of squamous or mixed histology non-small cell lung cancer.; 2. Treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage IIIB or IV).; - First cycle of pembrolizumab received after 06/01/2018; - Permanently discontinued 1L pembrolizumab treatment.; 3. Initiated second-line treatment at least 3 months prior to the date of data collection.; with either :; - Afatinib; - Any chemotherapy; 4. Age ≥ 18 years; Exclusion Criteria:; 1. Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Lung cancer patients
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  1) demographic and clinical characteristics of patients2) time on treatment 3) description of IR events
• Outcomes:
  1) demographic and clinical characteristics of patients2) time on treatment 3) description of IR events
• Data analysis plan:
  descriptive statistics