Post-Authorization Long-Term Safety Study of LUTATHERA

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

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).

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03691064.

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.

Trial PhaseNo phase specified

Trial TypeNot provided by clinicaltrials.gov

Lead OrganizationAdvanced Accelerator Applications

Description