Post-Authorization Long-Term Safety Study of LUTATHERA (SALUS)

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

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Study Overview

• Status: Active, not recruiting
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Drug: LUTATHERA

Detailed Description

To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

• Study Type: Observational
• Enrollment (Actual): 1014

Contacts and Locations

Study Locations

• France
  • Clichy, France
    • Novartis Investigative Site
  • Lyon, France
    • Novartis Investigative Site
  • Villejuif, France
    • Novartis Investigative Site
• Portugal
  • Coimbra, Portugal, 3000-075
    • Novartis Investigative Site
• Spain
  • La Corunya
    • Santiago de Compostela, La Corunya, Spain, 15706
      • Novartis Investigative Site
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Novartis Investigative Site
• United Kingdom
  • Birmingham, United Kingdom, B152WB
    • Novartis Investigative Site
  • Cambridge, United Kingdom, CB2 0QC
    • Novartis Investigative Site
  • Glasgow, United Kingdom, G12 OYN
    • Novartis Investigative Site
  • Liverpool, United Kingdom, L7 8XP
    • Novartis Investigative Site
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • London, United Kingdom, W6 8RF
    • Novartis Investigative Site
  • London, United Kingdom, SE5 9RS
    • Novartis Investigative Site
  • London, United Kingdom, NW32QG
    • Novartis Investigative Site
  • Manchester, United Kingdom
    • Novartis Investigative Site
  • Scheffield, United Kingdom, S102SJ
    • Novartis Investigative Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner MD Anderson Cancer Center
  • Ohio
    • Portland, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Oregon
    • Portland, Oregon, United States, 97339
      • Oregon Health & Sciences University Hospital
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason in Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.

Description

Inclusion Criteria:

• adult patients (fulfilling the definition of "age of majority" per local regulations),
• with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
• and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).

Exclusion Criteria:

• Hypersensitivity to Lutathera (active substance or any of the excipients),
• presence of established or suspected pregnancy or pregnancy not excluded,
• presence of kidney failure with creatinine clearance < 30 mL/min.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LUTATHERA; Treated per labeled LUTATHERA dosing regimen.	Drug: LUTATHERA; Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.; Other Names: Lu 177 dotatate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary cancers: incidence of secondary cancers	incidence of secondary cancers	up to 7 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety profile: incidence of adverse events	incidence of adverse events	up to 7 years follow-up
mortality	mortality (all cause)	up to 7 years follow-up
LUTATHERA dose per administration	average dose per administration	completion of treatment phase (approximately 2 years total)
LUTATHERA total dose	average total dose administered	completion of treatment phase (approximately 2 years total)
LUTATHERA number of administrations	average number of LUTATHERA doses	completion of treatment phase (approximately 2 years total)

Collaborators and Investigators

• Sponsor: Advanced Accelerator Applications
• Investigators: Study Director: Study Director, Advanced Accelerator Applications

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 22, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Gastroenteropancreatic neuroendocrine tumours
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Lutetium Lu 177 dotatate
• Other Study ID Numbers: A-LUT-T-E02-402; CAAA601A12402 (Other Identifier: Novartis); EUPAS25735 (Other Identifier: ENCePP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No