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 (Sep 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
Treatments studied
Radioligand therapy
Other
Cancer type
Neuroendocrine Tumor
Pancreatic Cancer
Biomarker criteria
Required: SSTR2 expression (positive)
Disease stage
Metastatic disease required
Grade: grade 1, grade 2, grade 3
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: sunitinib malate (sunitinib malate)
Cannot have received: lutetium lu 177 dotatate (lutetium lu 177 dotatate)
Cannot have received: radiopharmaceutical (metaiodobenzylguanidine, yttrium-90, radioactive iodide)
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 and 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 →Frequently asked questions
Is NCT05687123 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior sunitinib malate, lutetium lu 177 dotatate, radiopharmaceutical disqualifies patients from enrollment.
Does this trial require SSTR2?
Yes, SSTR2 expression 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.
Check if I qualify