OncoMatch/Clinical Trials/NCT05687123
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
Is NCT05687123 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Lutetium Lu 177 Dotatate and Sunitinib Malate for metastatic pancreatic neuroendocrine tumor.
Treatment: Lutetium Lu 177 Dotatate · Sunitinib Malate — This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Pancreatic Cancer
Disease stage
Required: Stage III, IV (AJCC v8)
Metastatic disease required
metastatic, unresectable well- or moderately-differentiated pancreatic neuroendocrine tumors (PNETs) of any grade
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: sunitinib (sunitinib malate)
Patients who have had prior treatment with sunitinib malate
Cannot have received: peptide receptor radionuclide therapy (lutetium Lu 177 dotatate)
Patients who have had prior treatment with lutetium Lu 177 dotatate therapy
Cannot have received: radiopharmaceutical (metaiodobenzylguanidine, yttrium-90, radioactive iodide)
other radiopharmaceuticals (including, but not limited to, metaiodobenzylguanidine [MIBG], yttrium-90 [Y-90], radioactive iodide [RAI])
Lab requirements
Blood counts
Absolute neutrophil count >= 1,000/mcL; Platelets >= 75,000/mcL; Hemoglobin > 8.0 g/dL; White blood cell count > 2000/mL
Kidney function
Creatinine clearance > 50 ml/min OR GFR >= 60 mL/min/1.73 m^2
Liver function
Total bilirubin <= 1.5 institutional ULN; AST/ALT <= 3 × institutional ULN
Cardiac function
NYHA class 2B or better; BP <= 140/90 mmHg; left ventricular ejection fraction > 50%
Absolute neutrophil count >= 1,000/mcL; Platelets >= 75,000/mcL; Total bilirubin <= 1.5 institutional ULN; AST/ALT <= 3 × institutional ULN; Creatinine clearance > 50 ml/min OR GFR >= 60 mL/min/1.73 m^2; Hemoglobin > 8.0 g/dL; White blood cell count > 2000/mL; Serum calcium <= 12.0 mg/dL; NYHA class 2B or better; BP <= 140/90 mmHg; left ventricular ejection fraction > 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- Memorial Hospital East · Shiloh, Illinois
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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