OncoMatch/Clinical Trials/NCT04086485
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
Is NCT04086485 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Lu-177-DOTATATE and Olaparib for gastroenteropancreatico tumors.
Treatment: Lu-177-DOTATATE · Olaparib · Amino Acid infusion — Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objective: To learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. Eligibility: Adults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells. Design: Eligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein. Participants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses. During the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer. Participants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls....
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: BRCA1 any tested
Known BRCA mutation status (Cohort 3 only).
Required: BRCA2 any tested
Known BRCA mutation status (Cohort 3 only).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: somatostatin analogue (octreotide, lanreotide, sandostatin)
Patients on somatostatin analogue therapy (e.g., but not only limited to sandostatin or lanreotide therapy) must have initiated and been on a consistent dose of therapy for at least 3 months prior to study enrollment.
Cannot have received: PARP inhibitor (olaparib)
Any previous treatment with PARP inhibitor, including olaparib
Cannot have received: systemic radionuclide agent (Lu-177-DOTATATE)
Any previous treatment with any systemic radionuclide agents. Previous treatment with Lu-177-DOTATATE.
Cannot have received: allogeneic hematopoietic stem cell transplant
Previous allogeneic hematopoietic stem cell transplant, allogeneic bone marrow transplant or double umbilical cord blood transplant (duCBT).
Lab requirements
Blood counts
Hemoglobin >= 10.0 g/dL with no blood transfusion in past 28 days; ANC >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L
Kidney function
Creatinine clearance >= 51 mL/min (MDRD equation or 24 hour urine test)
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x ULN unless liver metastases present, then <= 5x ULN
Patients must have normal organ and bone marrow function measured within 28 days prior to enrollment as defined below: Hemoglobin >= 10.0 g/dL with no blood transfusion in the past 28 days; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Total bilirubin <= 1.5 x institutional upper limit of normal (ULN); AST/ALT <= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be <= 5x ULN; Creatinine clearance estimated of >= 51 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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