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

Completed

• Conditions: Somatostatin Receptor-positive GEP-NET

• Registration Number: NCT04946305
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-30
• Study Start: 2022-05-10
• Primary Completion: 2024-07-08
• Study Completion: 2024-07-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Seoul, Korea, Republic of