RANDOMIZED PHASE II TRIAL IN SSTr2 POSITIVE TUMORS TO OPTIMIZE THE INTERVAL BETWEEN CYCLES OF PRRT WITH 177LU DOTATATE (LUTHREE)

INTERVENTION: Product Name: LU‐DOTATATE_IRSTIRCCS Product Code: LU‐DOTATATE_IRSTIRCCS Pharmaceutical Form: Solution for infusion INN or Proposed INN: LU‐DOTATATE_IRSTIRCCS Current Sponsor code: LU‐DOTATATE_IRSTIRCCS Other descriptive name: LU‐DOTATATE_IRSTIRCCS Concentration unit: GBq gigabecquerel(s) Concentration type: range Concentration number: 3.7‐5.5 CONDITION: SSTr2 POSITIVE TUMORS ; MedDRA version: 20.1 Level: HLGT Classification code 10027655 Term: Miscellaneous and site unspecified neoplasms malignant and unspecified System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: 1) Progression free survival (PFS); 2) Safety Primary end point(s): 1) PFS; 2) Safety Secondary Objective: 1) Disease Control Rate (DCR); 2) frequency of late toxicity; 3) Overal Survival (OS) in both arms; 4) dosimetry in the 6 patient for each risk population (3 for each ARM) to measure pharmacokinetics, activity biodistribution and absorbed dose to kidneys (critical organ) and tumour. ; 5) To confirm the prognostic and predictive role of PET FDG in subgroup of GEP NET and bronchial NET patients. ; Timepoint(s) of evaluation of this end point: 5 years SECONDARY OUTCOME: Secondary end point(s): Prognostic and predictive role of PET FDG Timepoint(s) of evaluation of this end point: 5 years INCLUSION CRITERIA: 1. Age >18 years. 2. Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2‐positive, that may benefit from receptor radionuclide therapy and for which there aren’t any other effective treatments. 3. Measurable disease according to RECIST 1.1.criteria; also patients without measurable but with evaluable disease can be enrolled. 4. Any disease stage is allowed. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan (the tumour uptake will be evaluated with a 3‐grade scale, where 1 = liver uptake, 2 > liver uptake and < kidney uptake and 3 > kidney uptake: only tumour uptakes grade 2 and 3 will be considered for therapy) and/or PET/CT 68Ga‐peptide images demonstrate a significant uptake in the tumour. 5. Patients with progressive disease in pre‐study period (PD within the last 12 months), refractory to convent