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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutathera | Patients administered Lutathera by prescription |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutathera | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Incidence of Adverse Events (AEs), Serious AE and unexpected AEs. | Up to 36 weeks |
| Incidence of Adverse Drug Reactions | Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs. | Up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in terms of Overall Response Rate (ORR) | 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 |
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Inclusion Criteria:
Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.
- somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Patients who are willing to provide written informed consent.
Exclusion Criteria:
1. Patients with contraindication according to prescribing information for Lutathera in Korea.
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Patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Seongnam-si | Gyeonggi-do | 13620 | South Korea | ||
| Novartis Investigative Site |
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| Up to 32 weeks (4 cycles of 8 weeks) |
| Seoul |
| 03722 |
| South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Seoul | 110-799 | South Korea |
| Novartis Investigative Site | Seoul | 137-040 | South Korea |
| Novartis Investigative Site | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| C447941 | lutetium Lu 177 dotatate |
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