An International, Non-Interventional, Post-Authorization Long-Term Safety Study of Lutathera®, in Patients with Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours (SALUS Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49428
• EU PAS number:
  EUPAS25735
• Study ID:
  49428
• Official title and acronym:
  An International, Non-Interventional, Post-Authorization Long-Term Safety Study of Lutathera®, in Patients with Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours (SALUS Study)
• DARWIN EU® study:
  No
• Study countries:
  France

  Portugal

  Spain

  United Kingdom

  United States
• Study description:
  This is a multinational, multicentre, non-interventional, retrospective and prospective study of patients with GEP-NET receiving treatment with Lutathera. This post-authorization safety study will be conducted with the aim to assess the safety profile of Lutathera and to characterize further the potential safety hazards described in the Risk Management Plan (RMP). It is part of the MAH-proposed safety management to monitor the long-term safety follow-up of Lutathera in the post-authorization setting. The SALUS study will be implemented with the objective to address the important identified risks, important potential risks, and relevant missing information from the controlled clinical trials conducted to obtain the marketing authorization of Lutathera.
• Study status:
  Ongoing

Research institution and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual: 18/12/2017

Study start date

Actual: 28/11/2018

Data analysis start date

Planned: 30/06/2028

Date of final study report

Planned: 30/11/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Advanced Accelerator Applications, a Novartis Company

Study protocol

Initial protocol

SALUS PROTOCOL_v 1.1 FINAL 15 June 2018_clean_Redacted (1)

Updated protocol

SALUS PROTOCOL_v 2.2 clean_final_signed with bookmark_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

A-LUT-T-E02-402,CAAA601A12402,NCT03691064