OncoMatch/Clinical Trials/NCT06784752
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Is NCT06784752 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Octreotide LAR for somatostatin receptor positive (sstr+).
Treatment: Octreotide LAR — The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Neuroendocrine Tumor
Pancreatic Cancer
Disease stage
Grade: 12 (who)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: therapeutic radiopharmaceutical
Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study
Cannot have received: interferon
Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET
Cannot have received: mTOR inhibitor
Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET
Cannot have received: chemotherapy
Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET
Cannot have received: systemic therapy
Exception: except somatostatin analogues (SSAs) of GEP-NET
Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET
Cannot have received: somatostatin analogue
Exception: more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible
Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible
Cannot have received: somatostatin analogue (short-acting octreotide)
Exception: cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE
any participant receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before the administration of [177Lu]Lu-DOTA-TATE
Cannot have received: somatostatin analogue
Exception: cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE
any participant receiving treatment with SSAs, which cannot be interrupted for at least 4 weeks before the administration of [177Lu]Lu-DOTA-TATE
Cannot have received: radioembolization
Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET
Cannot have received: chemoembolization
Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET
Cannot have received: radiofrequency ablation
Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET
Lab requirements
Blood counts
WBC count ≥ 2 x 10^9/L; Platelet count ≥ 75 x 10^9/L; Hemoglobin (Hb) ≥ 8 g/dL
Kidney function
Creatinine clearance > 40 mL/min calculated by the Cockcroft Gault method
Liver function
Total bilirubin ≤ 3 x ULN
Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Arizona · Scottsdale, Arizona
- Highlands Oncology Group · Fayetteville, Arkansas
- Rocky Mountain Cancer Centers · Denver, Colorado
- Hartford Hospital · Hartford, Connecticut
- Yale New Haven Hospital · New Haven, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06784752 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior therapeutic radiopharmaceutical, interferon, mTOR inhibitor disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 100 years or younger and at least 12 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages