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

Advanced Accelerator Applications

Status: Active, not recruiting

Conditions: Neuroendocrine Tumors

Treatments: Drug: LUTATHERA

Study type: Observational

Funder types: Industry

Identifiers

NCT03691064

CAAA601A12402 (Other Identifier)

A-LUT-T-E02-402

EUPAS25735 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,014 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,014 participants in 1 patient group

LUTATHERA

Description:

Treated per labeled LUTATHERA dosing regimen.

Treatment:

Drug: LUTATHERA