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:
  Disease /health condition

  Human medicinal product
• 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

• Medicinal product name:
  VARGATEF
• Study drug International non-proprietary name (INN) or common name:
  NINTEDANIB
• 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

• Study design:
  Non-interventional, multi-national, multi-site study
• 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.
• Summary results:
  In the non-interventional LUME-BioNIS study, Vargatef® plus docetaxel demonstrated real-world clinical effectiveness in patients with adenocarcinoma NSCLC previously treated with chemotherapy as well as both immunotherapy and chemotherapy.; The post hoc, exploratory analysis of the subgroup of patients with prior immunotherapy suggests that the Vargatef® plus docetaxel combination treatment yields greater efficacy when administered after immune; checkpoint inhibitors than administered without prior immunotherapy.; Safety findings were as expected and consistent with the known safety profile of Vargatef® plus docetaxel in patients with advanced NSCLC.; Despite comprehensive biomarker analyses(both clinical and molecular) using various analytic approaches, no new prognostic marker was identified for the OS outcome. Hence, no possible new predictive marker for OS was identified as well.; Given the efficacy and safety results of this non-interventional study, the benefit-risk balance of Vargatef® plus docetaxel remains unchanged in the approved indication.