Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

Two Steps Italian Prospective obsErvationAL Study Assessing the Effectiveness and Outcomes Associated With LUtathera (177Lu) Oxodotreotide Treatment in Adult Subjects With Unresectable or Metastatic, Progressive, Well Differentiated (G1 and G2), Somatostatin Receptor Positive Gastroenteropancreatic-neuroendocrine Tumours (GEP-NETs) - REAL-LU

This is a multicentre long-term non-interventional study of adult subjects diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs who have been prescribed Lutathera® in standard clinical practice.

Data on patients will be collected from the date when patient consent was obtained, during treatment with Lutathera® and for a follow-up period until end of study (EOS), defined as the time when the last enrolled patient has completed 36 months of assessments (unless early termination) after enrolment. Data will be collected in accordance with routine clinical visits.

The study duration will be 48 months in total: 12 months recruitment and 36 of follow-up from the last patient in.

Inclusion Criteria:

• Written informed consent must be obtained prior to any data collection.
• Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET).
• Aged ≥18 years.
• Patients must be naïve to treatment with Lutathera® at enrolment.

Exclusion Criteria:

• Participation in a current or prior investigational study within 30 days preceding enrolment or within 5 half-lives of the investigational product, whichever is longer.