A cross-sectional study to evaluate the effectiveness of XALKORI Patient Information Brochure among non-small cell lung cancer (NSCLC) patients receiving XALKORI treatment in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Evaluate the effectiveness of patient educational materials
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CRIZOTINIB
• Medical condition to be studied:
  Non-small cell lung cancer stage III

  Non-small cell lung cancer stage IV

Population studied

• Short description of the study population:
  Non-small cell lung cancer patients who have received XALKORI treatment within 90 days prior to taking the survey from September 2014 to September 2016 at major university hospitals or cancer centers in the 10 participating countries including Belgium, Denmark, France, Germany, Italy, the Netherlands, Sweden, Austria, Ireland, and the United Kingdom
• 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:
  Non-small cell lung cancer patients
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  The objective of this study is to evaluate the effectiveness of the XALKORI PIB implemented to mitigate the risks of visual disorders, QTc prolongation, hepatotoxicity, bradycardia, and ILD/pneumonitis in 6 countries in the European Union including Belgium, Denmark, France, Germany, Italy, and the Netherlands.
• Data analysis plan:
  All statistical summaries in this study will be descriptive. The study population will include all patients who are screened and eligible for this study. All variables collected in this study are categorical. Frequencies and percentages, with 95% confidence intervals (CIs) where appropriate, will be presented. Additional exploratory analyses and sensitivity analyses may be conducted.

Documents

Study results

Crizotinib A8081050 NI Study Report