First-line anticancer drugs in patients with advanced, primary Non-Small Cell Lung Cancer: drug-utilization and effectiveness studies from Tuscany Region healthcare database

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36693
• EU PAS number:
  EUPAS36692
• Study ID:
  36693
• Official title and acronym:
  First-line anticancer drugs in patients with advanced, primary Non-Small Cell Lung Cancer: drug-utilization and effectiveness studies from Tuscany Region healthcare database
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  The aim of the project is evaluate drug utilization and the effectiveness of first-line anticancer therapies approved for the treatment of advanced, non-resectable, NSCLC patients between 2009 and 2019 in the Tuscany population. Two studies will be thus performed on a cohort of patients with not-resectable, primary NSCLC: a drugs utilization study and a survival study. For the purpose of this study two different, already pseudo-anonymized, data sources will be used: pathology registry and administrative healthcare data of the Tuscany region.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

University of Siena, Department of Life Sciences and Departement of Medicine, Surgery and Neuroscience Siena, Via Aldo Moro 2

Study timelines

Date when funding contract was signed

Planned: 08/08/2020

Actual: 08/08/2020

Study start date

Planned: 15/08/2020

Actual: 08/08/2020

Date of final study report

Planned: 15/12/2020

Actual: 08/08/2020

Sources of funding

Other

More details on funding

No external funding

Study protocol

Initial protocol

200808_Encepp_First-line_NSCLC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable