Lutetium Lu 177 Dotatate

DRUG14 trials

Sponsors

Mayo Clinic, M.D. Anderson Cancer Center, National Cancer Institute (NCI), OHSU Knight Cancer Institute, Alliance for Clinical Trials in Oncology

Conditions

Advanced Lung Neuroendocrine TumorAnatomic Stage IV Breast Cancer AJCC v8Digestive System Neuroendocrine TumorDigestive System Neuroendocrine Tumor G1Digestive System Neuroendocrine Tumor G2Functioning Lung Neuroendocrine TumorGrade 1 MeningiomaGrade 2 Meningioma

Phase 1

Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors

Active, not recruitingNCT04234568

National Cancer Institute (NCI)Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Neuroendocrine Tumor

Start: 2020-07-20End: 2026-03-14Updated: 2025-12-22

Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors

Active, not recruitingNCT04750954

National Cancer Institute (NCI)Neuroendocrine Neoplasm

Start: 2021-07-22End: 2026-06-30Target: 29Updated: 2026-04-03

Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors

RecruitingNCT05687123

National Cancer Institute (NCI)Metastatic Pancreatic Neuroendocrine Tumor, Pancreatic Neoplasm, Stage III Pancreatic Neuroendocrine Tumor AJCC v8 +2

Start: 2024-08-14End: 2026-12-14Target: 24Updated: 2026-03-30

Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.

RecruitingNCT07150546

Emory UniversityDigestive System Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Neoplasm, Unresectable Digestive System Neuroendocrine Tumor G1 +1

Start: 2025-10-14End: 2027-09-30Target: 15Updated: 2026-03-02

Phase 2

Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

RecruitingNCT04082520

Mayo ClinicGrade 1 Meningioma, Grade 2 Meningioma, Grade 3 Meningioma +2

Start: 2020-04-14End: 2031-01-06Target: 41Updated: 2025-12-11

Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers

WithdrawnNCT04106843

M.D. Anderson Cancer CenterLocally Advanced Adrenal Gland Pheochromocytoma, Locally Advanced Paraganglioma, Metastatic Adrenal Gland Pheochromocytoma +11

Start: 2019-06-13End: 2020-09-03Updated: 2020-09-07

177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer

Not yet recruitingNCT04529044

OHSU Knight Cancer InstituteAnatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma

Start: 2025-12-01End: 2026-12-20Target: 10Updated: 2025-10-30

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

RecruitingNCT04665739

National Cancer Institute (NCI)Advanced Lung Neuroendocrine Tumor, Functioning Lung Neuroendocrine Tumor, Locally Advanced Lung Neuroendocrine Neoplasm +9

Start: 2023-02-03End: 2033-01-16Target: 70Updated: 2026-04-03

Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors

Active, not recruitingNCT05247905

Alliance for Clinical Trials in OncologyMetastatic Pancreatic Neuroendocrine Tumor, Unresectable Pancreatic Neuroendocrine Carcinoma

Start: 2023-02-16End: 2033-10-01Updated: 2025-04-02

Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer

RecruitingNCT05583708

Weill Medical College of Cornell UniversityMerkel Cell Carcinoma

Start: 2023-08-03End: 2026-09-30Target: 18Updated: 2025-05-23

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

RecruitingNCT05691465

National Cancer Institute (NCI)Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Neuroendocrine Carcinoma, Metastatic Prostate Small Cell Neuroendocrine Carcinoma +1

Start: 2023-12-27End: 2026-11-02Target: 30Updated: 2026-04-03

Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors

Active, not recruitingNCT05724108

National Cancer Institute (NCI)Metastatic Neuroendocrine Tumor

Start: 2023-08-30End: 2026-12-09Target: 94Updated: 2026-04-03

Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial

RecruitingNCT05773274

National Cancer Institute (NCI)Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Digestive System Neuroendocrine Tumor G2, Unresectable Digestive System Neuroendocrine Tumor G1 +1

Start: 2024-01-12End: 2026-04-30Target: 100Updated: 2026-04-03

Phase 4

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

RecruitingNCT06016855

Vanderbilt-Ingram Cancer CenterDigestive System Neuroendocrine Tumor G1, Digestive System Neuroendocrine Tumor G2, Metastatic Digestive System Neuroendocrine Neoplasm +3

Start: 2024-05-31End: 2028-05-28Target: 6Updated: 2025-12-17

Related Papers

NCI 10479: A phase I dose escalation-expansion trial of sunitinib malate plus lutetium (Lu-177) dotatate in somatostatin receptor positive pancreatic neuroendocrine tumors.

Journal of Clinical Oncology2025-05-28

A Randomized clinical trial evaluating the impact on survival and quality of life of <sup>177</sup>Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217).

2025-04-042 citations

Population Pharmacokinetic-Pharmacodynamic Modeling for Triapine to Optimize Dosing Regimen

2025-02-18

A phase II randomized control trial of triapine plus lutetium 177 DOTATATE versus lutetium 177 DOTATATE alone for well-differentiated somatostatin receptor-positive neuroendocrine tumors.

Journal of Clinical Oncology2024-06-011 citations

Abstract 5165: Development and validation of an assay for the characterization of SSTR2 expression on CTCs from liquid biopsies

Cancer Research2024-03-22

Radium-223 in women with hormone receptor-positive bone-metastatic breast cancer receiving endocrine therapy: pooled analysis of two international, phase 2, randomized, double-blind, placebo-controlled trials

Breast Cancer Research and Treatment2023-12-209 citations

A Phase Ib Study of the DNA-PK Inhibitor Peposertib Combined with Neoadjuvant Chemoradiation in Patients with Locally Advanced Rectal Cancer

Clinical Cancer Research2023-12-0528 citations

Abstract CT194: ETCTN 10388: a first in human phase I trial of triapine and lutetium Lu 177 DOTATATE in well-differentiated somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Cancer Research2023-04-142 citations

hPG80 (Circulating Progastrin), a Novel Blood-Based Biomarker for Detection of Poorly Differentiated Neuroendocrine Carcinoma and Well Differentiated Neuroendocrine Tumors

Cancers2022-02-096 citations

Abstract 674: A phase I trial of Triapine and Lutetium Lu 177 Dotatate in combination for well-differentiated somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Cancer Research2021-07-013 citations