A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea

A Post Marketing Surveillance on Lutathera® (Lutetium (177Lu) Oxodotreotide, 177Lu-DOTA0-Tyr3-Octreotate) in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) in Korea

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04946305

Enrollment

Registered

2021-06-30

Start date

2022-05-10

Completion date

2024-07-08

Last updated

2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatostatin Receptor-positive GEP-NET

Keywords

somatostatin receptor-positive GEP-NET, Lutathera, Observational, prospective

Brief summary

This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.

Interventions

OTHERLutathera

Prospective observational study. There is no treatment allocation. Patients administered Lutathera by prescription that have started before inclusion of the patient into the study will be enrolled.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling. \- somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. 2. Patients who are willing to provide written informed consent.

Exclusion criteria

1\. Patients with contraindication according to prescribing information for Lutathera in Korea.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Adverse Events	Up to 36 weeks	Incidence of Adverse Events (AEs), Serious AE and unexpected AEs.
Incidence of Adverse Drug Reactions	Up to 36 weeks	Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs.

Secondary

Measure	Time frame	Description
Effectiveness in terms of Overall Response Rate (ORR)	Up to 32 weeks (4 cycles of 8 weeks)	ORR is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1. Partial Response (PR): At least a 30% decrease from baseline, confirmed at 4 weeks. Complete Response (CR): Disappearance of all known disease, confirmed at 4 weeks, lymph nodes must be less than 10 mm short axis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026