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| Therapy Name | Lutetium Lu 177 dotatate |
| Synonyms | |
| Therapy Description |
Lutathera (lutetium Lu 177 dotatate) is a radiolabeled somatostatin analog that may selectively kill somatostatin receptor-positive tumor cells (PMID: 28076709). Lutathera (lutetium Lu 177 dotatate) is FDA approved for use in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (FDA.gov). |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Lutetium Lu 177 dotatate | Lutathera | LuTate|177Lu-Octreotate|177 Lu-DOTA-Tyr3-octreotate|177Lu-DOTATATE | Lutathera (lutetium Lu 177 dotatate) is a radiolabeled somatostatin analog that may selectively kill somatostatin receptor-positive tumor cells (PMID: 28076709). Lutathera (lutetium Lu 177 dotatate) is FDA approved for use in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04106843 | Phase II | Lutetium Lu 177 dotatate | Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers | Withdrawn | USA | 0 |
| NCT02230176 | Phase II | Sunitinib Lutetium Lu 177 dotatate | Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II (OCCLURANDOM) | Completed | FRA | 0 |
| NCT04665739 | Phase II | Everolimus Lutetium Lu 177 dotatate | Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors | Recruiting | USA | 0 |
| NCT05987176 | Phase II | Lutetium Lu 177 dotatate | Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases (NELMAS) | Recruiting | GBR | 0 |
| NCT03966651 | Phase I | Lutetium Lu 177 dotatate | A Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors. (NEUROBLU 02) | Recruiting | FRA | 0 |
| NCT02754297 | Phase II | Lutetium Lu 177 dotatate | Personalized PRRT of Neuroendocrine Tumors (P-PRRT) | Active, not recruiting | CAN | 0 |
| NCT05610826 | Phase Ib/II | Lutetium Lu 177 dotatate | Preoperative PRRT Versus Surgical Cytoreduction in Metastatic Pancreatic Neuroendocrine Tumors to the Liver | Withdrawn | USA | 0 |
| NCT04903899 | Phase II | Lutetium Lu 177 dotatate | 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma (LuDO-N) | Recruiting | SWE | NOR | NLD | LTU | DNK | 0 |
| NCT04614766 | Phase Ib/II | 131I-MIBG + Lutetium Lu 177 dotatate Lutetium Lu 177 dotatate | A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors (SPORE-3) | Withdrawn | USA | 0 |
| NCT04954820 | Phase II | Lutetium Lu 177 dotatate | Assessment of the Schema of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor (ReLUTH) | Recruiting | FRA | 0 |
| NCT05724108 | Phase II | Lutetium Lu 177 dotatate Lutetium Lu 177 dotatate + Triapine | 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 | Recruiting | USA | 0 |
| NCT07150546 | Phase I | Lutetium Lu 177 dotatate | Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors. | Not yet recruiting | USA | 0 |
| NCT05773274 | Phase II | Everolimus Lutetium Lu 177 dotatate | Comparing Retreatment of 177Lu-DOTATATE PRRT Versus Everolimus in Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial | Recruiting | USA | CAN | 0 |
| NCT03971461 | Phase II | Lutetium Lu 177 dotatate | Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma | Active, not recruiting | USA | 0 |
| NCT05691465 | Phase II | Lutetium Lu 177 dotatate | Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells | Recruiting | USA | 0 |
| NCT04529044 | Phase II | Lutetium Lu 177 dotatate | 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer | Not yet recruiting | USA | 0 |
| NCT05247905 | Phase II | Lutetium Lu 177 dotatate Capecitabine + Temozolomide | Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors | Active, not recruiting | USA | 0 |
| NCT06395402 | Phase II | Lutetium Lu 177 dotatate | 177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry (LUMOD-ID) | Recruiting | USA | 0 |
| NCT04609592 | Phase I | Lutetium Lu 177 dotatate | Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery | Recruiting | USA | 0 |
| NCT06016855 | FDA approved | Lutetium Lu 177 dotatate | Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors | Recruiting | USA | 0 |
| NCT06326190 | Phase II | Sunitinib Octreotide acetate Hydroxyurea Lutetium Lu 177 dotatate Bevacizumab Everolimus | 177Lu-DOTATATE for Recurrent Meningioma (LUMEN-1) | Recruiting | NOR | FRA | ESP | CHE | AUT | 0 |
| NCT04082520 | Phase II | Lutetium Lu 177 dotatate | Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy | Recruiting | USA | 0 |