This study is a phase 2, open, single-site trial. The primary objective of this study is to prospectively evaluate the safety and efficacy in participants treated with Lu-177 DOTATATE (Lutathera) in unresectable or metastatic, somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications (eg, bronchial and thymic NET; paraganglioma/phaeochromocytoma; medullary thyroid carcinoma; and those requiring repeat peptide receptor radionuclide therapy (PRRT) with 2 further cycles of Lutathera). The aim is to recruit a total of 75-110 participants. Each patient will receive 4 cycles of Lutathera with 8-12 weeks time interval (except patients requiring repeat PRRT will receive 2 further cycles of Lutathera). The follow-up period will be for 2 years from the date of the last treatment.
Patients ≥18 years of age.
Participants capable of giving informed consent
Presence of unresectable or metastatic, well differentiated, somatostatin receptor positive non gastroenteropancreatic neuroendocrine tumours. Or for those having 2 cycles repeat therapy, GEP NET > 18 months from start of previous PRRT.
Patients must have progressive disease based on RECIST Criteria, Version 1.1. In order to make the assessment, two CT (or MRI) scans are required. The oldest scan must not be older than 3 years from the date of enrolment. The most recent scan must not be older than 6 weeks from the date of enrolment.
Participants will not be eligible for trial participation if they meet any of the exclusion criteria, or will be discontinued at the discretion of the Investigator if they develop any of the exclusion criteria during the trial.
Either serum creatinine >150 μmol/L (>1.7 mg/dL), or calculated creatinine clearance <40 mL/min, eventually confirmed by measured creatinine clearance (or measured GFR using isotopic GFR measurement) <40 mL/min (the measured creatinine clearance/GFR is required only as confirmatory exam).
Haemoglobin concentration <5.0 mmol/L (<8.0 g/dL); WBC <2 x109/L (2000/mm3); platelets <75 x109/L (75 x103/mm3).
Total bilirubin >3x upper limit of normal (ULN).
Single group
Lu-177 DOTATATE (Lutathera®)
DrugTreatment with Lutathera will consist of a total cumulative intravenous (IV) administered radioactivity dose of 29.6 GBq (800 mCi) or 14.8 GBq (400 mCi) for 4 cycles or 2 cycles of Lutathera, respectively.
To prospectively evaluate safety in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications
Treatment-related toxicity will be assessed in all participants by Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0. This will be done by performing electrocardiograms (ECGs), vital signs, and clinical laboratory tests (haematology, clinical chemistry, or urinalysis)at the baseline and before and after every treatment and during the follow-up period.
To prospectively evaluate tolerability in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications
Treatment-related side effects and cancer-related symptoms will be assessed in all participants Questionnaire after every treatment and during the follow-up period.
To prospectively evaluate efficacy in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor expressing neuroendocrine tumours (NET) in currently unlicensed indications
The efficacy of Lu-177 DOTATATE is assessed in all participants by measuring Progression Free Survival (PFS) and defined as the time from the date of start of treatment the date of the first documented tumour progression or death due to any cause.
• To determine the Objective Response Rate (ORR)
ORR is defined by evaluating post-therapy scans (using RECIST Criteria, Version 1.1) looking for the percentage of patients who had a partial response or complete response from the whole cohort over the treatment time of 2 years.
• To determine the Overall Survival (OS).
Overall Survival (OS) is defined as the time from the date of start of treatment till death or loss of contact or end of trial.
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