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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/37252
• EU PAS number:
  EUPAS11885
• Study ID:
  37252
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  Germany

  Greece

  Hungary

  Italy

  Lithuania

  Luxembourg

  Netherlands

  Spain

  Sweden

  United Kingdom
• Study description:
  To explore whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict overall survival (OS) in NSCLC patients eligible for treatment with Vargatef® according to the approved label.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 71 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 12/06/2015

Study start date

Planned: 09/03/2016

Actual: 09/03/2016

Data analysis start date

Planned: 01/11/2019

Actual: 14/03/2016

Date of final study report

Planned: 30/06/2020

Actual: 08/07/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable