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 (Jun 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
Treatments studied
Radioligand therapy
Other
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.
Frequently asked questions
Is NCT06878664 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radioligand therapy, external beam radiation therapy, internal radiation therapy disqualifies patients from enrollment.
Does this trial require SSTR?
Yes, SSTR overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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