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 type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multi-site study

Study drug and medical condition

• Name of medicine, other:
  Gilotrif
• Study drug International non-proprietary name (INN) or common name:
  AFATINIB
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Short description of the study population:
  The study population involved patients aged 18 years or older diagnosed with squamous or mixed histology non-small cell lung cancer received treatment with pembrolizumab in combination with platinum doublet chemotherapy as 1st line treatment followed by either afatinib or chemotherapy as 2nd line treatment.; Inclusion Criteria:;  Diagnosis of squamous or mixed histology non-small cell lung cancer.;  Treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage IIIB or IV).; o First cycle of pembrolizumab containing therapy received after 06/01/2018.; o Permanently discontinued 1L pembrolizumab containing treatment.;  Initiated second-line treatment at least 3 months prior to data collection with either:; o Afatinib; o Any chemotherapy;  Age ≥ 18 years ; ; Exclusion Criteria:;  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:
  Patients with non-small cell lung cancer
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To assess the time on treatment for patients who, after failure of 1L pembrolizumab in combination with chemotherapy, received either afatinib in 2L or chemotherapy in 2L
• Outcomes:
  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).
• Data analysis plan:
  Descriptive analysis of demographics, clinical characteristics, and treatment history of patients treated in 2L with afatinib and those treated in 2L chemotherapy. Time on treatment will be described in each 2L cohort (with no comparisons made) using the Kaplan-Meier method, and the median, along with two-sided 95% confidence intervals, and 3-, 6-, 9- and 12-month rates of discontinuation will be reported. Time on treatment is defined in months as the interval from the start of 2L treatment until the end of 2L treatment or death date by any cause. Incidence rates of severe irAEs of specific interest during 2L afatinib treatment or 2L chemotherapy will be estimated as the number of events divided by the total person-years of follow-up. Additionally, the incidence rates among patients who completed 2L therapy will be reported.

Documents

Study results

Afatinib RWE_March 2021 Clin Lung Cancer