{"id":"177lu-dotatoc","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Hematologic toxicity (anemia, thrombocytopenia, leukopenia)"},{"rate":null,"effect":"Renal toxicity"},{"rate":null,"effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL3707297","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"177Lu-DOTATOC combines lutetium-177, a beta-emitting radioisotope, with DOTATOC (a somatostatin receptor 2 agonist peptide). The peptide targets somatostatin receptors overexpressed on neuroendocrine tumors, allowing selective delivery of cytotoxic radiation to tumor cells while sparing normal tissue. This is a form of peptide receptor radionuclide therapy (PRRT).","oneSentence":"177Lu-DOTATOC is a radiolabeled somatostatin analog that binds to somatostatin receptors on neuroendocrine tumor cells and delivers targeted radiation therapy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:56:14.256Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Somatostatin receptor-positive neuroendocrine tumors (NET)"},{"name":"Gastroenteropancreatic neuroendocrine tumors (GEP-NET)"}]},"trialDetails":[{"nctId":"NCT05691465","phase":"PHASE2","title":"Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-12-27","conditions":"Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Neuroendocrine Carcinoma, Metastatic Prostate Small Cell Neuroendocrine Carcinoma","enrollment":30},{"nctId":"NCT05918302","phase":"PHASE3","title":"Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","status":"RECRUITING","sponsor":"Grupo Espanol de Tumores Neuroendocrinos","startDate":"2023-10-27","conditions":"Neuroendocrine Tumors, Lung Neuroendocrine Neoplasm, Thymus Neoplasms","enrollment":120},{"nctId":"NCT07150546","phase":"PHASE1","title":"Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.","status":"RECRUITING","sponsor":"Emory University","startDate":"2025-10-14","conditions":"Digestive System Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Neoplasm, Unresectable Digestive System Neuroendocrine Tumor G1","enrollment":15},{"nctId":"NCT06441331","phase":"PHASE1","title":"Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors","status":"RECRUITING","sponsor":"ITM Solucin GmbH","startDate":"2025-09-26","conditions":"Somatostatin Receptor Positive, NETs, Lymphoma","enrollment":20},{"nctId":"NCT04082520","phase":"PHASE2","title":"Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2020-04-14","conditions":"Grade 1 Meningioma, Grade 2 Meningioma, Grade 3 Meningioma","enrollment":41},{"nctId":"NCT04529044","phase":"PHASE2","title":"177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"OHSU Knight Cancer Institute","startDate":"2025-12-01","conditions":"Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma","enrollment":10},{"nctId":"NCT06256705","phase":"NA","title":"Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2024-03-25","conditions":"Gastroenteropancreatic Neuroendocrine Tumor, Radiotherapy","enrollment":80},{"nctId":"NCT04919226","phase":"PHASE3","title":"Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE","status":"ACTIVE_NOT_RECRUITING","sponsor":"ITM Solucin GmbH","startDate":"2021-12-21","conditions":"Neuroendocrine Tumors","enrollment":259},{"nctId":"NCT05387603","phase":"PHASE3","title":"Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.","status":"RECRUITING","sponsor":"Lund University Hospital","startDate":"2022-11-01","conditions":"Neuroendocrine Tumors","enrollment":300},{"nctId":"NCT04609592","phase":"PHASE1","title":"Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery","status":"RECRUITING","sponsor":"Stanford University","startDate":"2021-03-17","conditions":"Gastroenteropancreatic Neuroendocrine Tumor","enrollment":10},{"nctId":"NCT03049189","phase":"PHASE3","title":"Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"ITM Solucin GmbH","startDate":"2017-02-02","conditions":"Neuroendocrine Tumors","enrollment":309},{"nctId":"NCT04997317","phase":"PHASE1, PHASE2","title":"Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2021-04-21","conditions":"Meningioma","enrollment":18},{"nctId":"NCT06611891","phase":"PHASE3","title":"Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer","status":"RECRUITING","sponsor":"University Hospital, Grenoble","startDate":"2025-01-06","conditions":"Breast Cancer Metastatic","enrollment":25},{"nctId":"NCT04917484","phase":"PHASE2","title":"Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients","status":"RECRUITING","sponsor":"Tine Gregersen, MD","startDate":"2020-02-01","conditions":"Neuroendocrine Neoplasm","enrollment":100},{"nctId":"NCT06045260","phase":"PHASE2","title":"\"Receptor Radionuclide Therapy With 177Lu-DOTATOC","status":"RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2023-09-13","conditions":"Neuroendocrine Tumors, Paraganglioma, Pheochromocytoma","enrollment":100},{"nctId":"NCT05359146","phase":"EARLY_PHASE1","title":"Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3)","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2023-03-28","conditions":"Neuroendocrine Neoplasia's (NENs), Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)","enrollment":16},{"nctId":"NCT04385992","phase":"PHASE2","title":"Neoadjuvant PRRT With 177Lu-DOTATATE Followed by Surgery for Resectable PanNET","status":"COMPLETED","sponsor":"IRCCS San Raffaele","startDate":"2020-03-09","conditions":"Neuroendocrine Tumors","enrollment":31},{"nctId":"NCT04276597","phase":"PHASE2","title":"Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.","status":"WITHDRAWN","sponsor":"Excel Diagnostics and Nuclear Oncology Center","startDate":"2020-03-04","conditions":"Pulmonary Neuroendocrine Neoplasm, Pheochromocytoma, Paraganglioma","enrollment":""},{"nctId":"NCT04915144","phase":"PHASE2","title":"177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs","status":"WITHDRAWN","sponsor":"British Columbia Cancer Agency","startDate":"2023-01-15","conditions":"Neuroendocrine Tumors, Carcinoid Tumor, Pulmonary Carcinoid Tumor","enrollment":""},{"nctId":"NCT03923257","phase":"PHASE1, PHASE2","title":"Dosimetry Guided PRRT With 177Lu-DOTATATE in Children and Adolescents","status":"WITHDRAWN","sponsor":"Sue O'Dorisio","startDate":"2020-08-04","conditions":"Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma","enrollment":""},{"nctId":"NCT04790708","phase":"NA","title":"Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)","status":"UNKNOWN","sponsor":"University Hospital of Ferrara","startDate":"2018-07-02","conditions":"Neuroendocrine Tumors, Peptide Receptor Radionuclide Therapy (PRRT)","enrollment":250},{"nctId":"NCT04194125","phase":"PHASE2","title":"Personalized CAPTEM Radiopeptide Therapy of Advanced, Non-resectable Neuroendocrine Cancer","status":"UNKNOWN","sponsor":"University of Warmia and Mazury","startDate":"2019-02-01","conditions":"Neuroendocrine Tumors","enrollment":25},{"nctId":"NCT01099228","phase":"NA","title":"Combination Targeted Radiotherapy in Neuroendocrine Tumors","status":"COMPLETED","sponsor":"David Bushnell","startDate":"2006-09","conditions":"Neuroendocrine Tumors","enrollment":2},{"nctId":"NCT00978211","phase":"PHASE2","title":"DOTA-TOC in Metastasized Neuroendocrine Tumors","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"1997-09","conditions":"Neuroendocrine Tumors","enrollment":1499}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"177Lu-DOTATOC","genericName":"177Lu-DOTATOC","companyName":"University Hospital, Basel, Switzerland","companyId":"university-hospital-basel-switzerland","modality":"Small molecule","firstApprovalDate":"","aiSummary":"177Lu-DOTATOC is a radiolabeled somatostatin analog that binds to somatostatin receptors on neuroendocrine tumor cells and delivers targeted radiation therapy. Used for Somatostatin receptor-positive neuroendocrine tumors (NET), Gastroenteropancreatic neuroendocrine tumors (GEP-NET).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}