Vargatef in 2nd-line therapy of advanced or metastatic adenocarcinoma of the lung (VARGADO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38264
• EU PAS number:
  EUPAS12795
• Study ID:
  38264
• Official title and acronym:
  Vargatef in 2nd-line therapy of advanced or metastatic adenocarcinoma of the lung (VARGADO)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 31/01/2015

Actual: 31/01/2015

Study start date

Planned: 27/04/2015

Actual: 27/04/2015

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Pharma GmbH

Regulatory

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