Prospective International Observational Cohort Study Assessing Safety Outcomes Among Squamous Non-small Cell Lung Cancer Patients Treated with Necitumumab in Combination with Gemcitabine and Cisplatin in Comparison to Patients Treated with Cisplatin-based Doublets (I4X-MC-B002)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Cohort 1 ~667 patients receiving first-line necitumumab in combination with gemcitabine and cisplatin treatment, Cohort 2 ~333 patients receiving first-line cisplatin-based doublets without necitumumab
• 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)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To characterise and compare the incidence of select adverse events inlocally advanced or metastatic squamous non-small cell lung cancer patients receiving treatment of necitumumab in combination with gemcitabine and cisplatin or patients treated with cisplatin-based doublets under real-world conditions
• Outcomes:
  The safety outcomes of interest include thromboembolic events, cardiorespiratory disorders, and severe electrolyte disturbances, Real-world use of thromboprophylaxis, real-world management of hypomagnesaemia, incidence of other treatment-emergent adverse events of interest under real-world conditions, ECGs as obtained in target population, EGFR protein expression status as well as EGFR and KRAS mutation status, supportive care and hospitalization(s) and reasons for hospitalization(s) of target population
• Data analysis plan:
  Descriptive analyses (including standard univariate analyses) will be conducted to evaluate demographic and clinical characteristics and crude incidence proportion and rate of AEs. Categorical measures will be summarised as counts and percentages, while continuous measures will be summarised using mean, median, standard deviation, and range.Propensity score stratification will be performed to adjust for baseline differences in potential confounding factors to compare the risk of AEs of interest in patients receiving first-line necitumumab in combination with gemcitabine and cisplatin to those who receive other first-line cisplatin-based doublets.