A non-interventional biomarker study in patients with Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology eligible for treatment with Vargatef® according to the approved label (LUME BioNIS)

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:
  Biomarker assessment
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VARGATEF
• Medical condition to be studied:
  Non-small cell lung cancer stage IIIB

Population studied

• Short description of the study population:
  NSCLC patients eligible for treatment with Vargatef®.
• 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:
  260

Study design details

• Main study objective:
  Overall Survival in relation to exploratory biomarker assessment, including gene-expressions and genomic alterations.
• Outcomes:
  Overall Survival, Disease progression
• Data analysis plan:
  Biomarkers will be investigated by univariate and multivariate prediction models and regression analysis.For all univariate screening approaches, multiplicity correction of p-values will be performed.Model performances will be quantified and uncertainty will be evaluated by resampling methods.Categorical biomarkers will only be investigated provided there are sufficient patient numbers within the subgroups defined by the categorical biomarkers. For all selected categorical biomarkers the estimate of the HR/odds ratio and its 95% confidence interval (CI) will be presented. For continuous biomarkers the HR/odds ratio for a change per unit will be presented.