OncoMatch/Clinical Trials/NCT06878664
Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
Is NCT06878664 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 16 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm. and 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 8 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm. for grade1-2 advanced midgut neuroendocrine tumors (nets).
Treatment: 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 16 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm. · 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 8 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm. · Amino acid solution · Lanreotide (Autogel formulation) or Octreotide LAR — This is a randomized Phase II/late phase I de-escalation clinical trial with approved investigational medicinal products in new use condition, low intervention. Disease under study Patients with unresectable or metastatic, slowly progressive, well-differentiated (Grade1 and Grade2), somatostatin receptor-positive midgut neuroendocrine tumors (GEP-NETs). It is planned to randomize 166 patients with a histologically confirmed diagnosis of slowly progressive grade 1 or grade 2 advanced midgut neuroendocrine tumors (NETs) candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT). Patients are required to have SSTR+ disease, as evidenced on somatostatin receptor imaging. Patients will be randomized into two arms: 1. control arm: regimen 177Lu-Dotatate every 8 weeks (q8w) 2. experimental arm: regimen 177Lu-Dotatate every 16 weeks (q16w) Research hypothesis: Less intensive somatostatin-receptor (SST) targeted radioligand therapy (RLT) (7.4 GBq/cycle 177Lu-Dotatate every 16 weeks x 4 cycles) is associated with less severe hematological toxicities and may mitigate the risk to develop therapy-related myeloid neoplasms (t-MN) with similar antitumor efficacy in slowly growing gastrointestinal grade 1-2 NETs.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: SSTR overexpression (SSTR positive (equal or above liver uptake on imaging))
all RECIST v1.1 evaluable target lesions and non-target lesions need to be SSTR positive (SSTR+) as defined by equal or above the liver uptake
Prior therapy
Cannot have received: radioligand therapy
Prior radioligand therapy (RLT) (not restricted to 177Lu-Dotatate)
Cannot have received: external beam radiation therapy
Exception: to more than 25% of the bone marrow
Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow
Cannot have received: internal radiation therapy
Exception: whole liver
Prior whole liver internal radiation therapy (SIRT)
Cannot have received: major surgery, systemic therapy, embolization or other locoregional treatments
Exception: within 4 weeks of study entry
Prior major surgery, systemic therapy, embolization or other locoregional treatments within 4 weeks of study entry
Lab requirements
Blood counts
Neutrophil count (ANC) ≥ 2,000/mm3; Platelet count ≥ 75 × 10^9/L; Hemoglobin ≥ 8 g/dL
Kidney function
Creatinine clearance (CrCl) ≥ 50 mL/min as estimated by Cockroft-Gault or measured by 24-hour urine collection (GFR can also be used); renal tract obstruction is not allowed.
Liver function
Serum bilirubin ≤ 3.0 × ULN or ≤ 3 × ULN for subjects with Gilbert's disease; ALT and AST ≤ 2.5 × ULN or ≤ 5 xULN for subjects with liver metastases; Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
Adequate organ function (hematological, renal and liver) based upon meeting all of the following laboratory criteria: ... (see full text above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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