13 recruiting, 5 active not recruiting, 2 withdrawn, 1 completed. 10 Phase 1, 6 Phase 2, 4 Phase 3, 1 Early Phase 1, 1 Phase 4.
Follow Lutetium: new trials by email Literature Review of Lutetium trials Research Report on Lutetium
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer Lutetium (177Lu) DGUL, Pembrolizumab - Metastatic Castration-resistant Prostate Cancer (mCRPC) | Phase 1 | Recruiting | Cellbion Co., Ltd. | 30 | 2026-07-29 | 2026-10-07 |
| A Study of Lutetium [177Lu]-BL-ARC001 in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors Lutetium [177Lu] BL-ARC001 - Lung Cancer, Breast Cancer | Phase 1 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 22 | 2025-12-10 | 2026-01-06 |
| A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors Lutetium [177Lu] BL-ARC001 - Gastrointestinal Tumors, Solid Tumors | Phase 1 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 22 | 2025-11-14 | 2026-01-07 |
| Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors. Stereotactic Body Radiation Therapy, Lutetium Lu 177 Dotatate, Computed Tomography - Digestive System Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Neoplasm | Phase 1 | Recruiting | Emory University | 15 | 2025-10-14 | 2026-03-02 |
| An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC AAA617, ARPI: Abiraterone, ARPI: Enzalutamide - Metastatic Castration Resistant Prostate Cancer (mCRPC) | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 7 | 2025-09-11 | 2026-10-21 |
| Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 16 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm., 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 8 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm., Amino acid solution - Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs) | Phase 3 | Recruiting | Grupo Espanol de Tumores Neuroendocrinos | 166 | 2025-06-12 | 2026-09-16 |
| 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer Lutetium (177Lu) vipivotide tetraxetan - Prostate Cancer | Phase 2 | Recruiting | Maria Sklodowska-Curie National Research Institute of Oncology | 200 | 2025-01-09 | 2026-10-16 |
| A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study AAA617, Gonadotropin-releasing hormone (GnRH) analogues, Gonadotropin-releasing hormone (GnRH) antagonists - Metastatic Castration-Resistant Prostate Cancer | Phase 1 | Active not recruiting | Novartis Pharmaceuticals | 110 | 2024-11-11 | 2026-10-20 |
| A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer lutetium (177Lu) rhPSMA 10.1 and Pluvicto® - Metastatic Prostate Cancer | Early Phase 1 | Terminated | Blue Earth Therapeutics Ltd | 17 | 2024-10-31 | 2025-09-25 |
| Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer lutetium (177Lu) vipivotide tetraxetan - Metastatic Castration Resistant Prostate Cancer | Recruiting | Novartis Pharmaceuticals | 500 | 2024-09-04 | 2026-07-13 | |
| A Clinial Trial of Lutetium [177Lu]-FAP-75 for the Treatment of Patients With Advanced Solid Tumors Lutetium [177Lu]-FAP-75 - Solid Tumors | Phase 1 | Unknown | Fudan University | 50 | 2024-08-19 | 2024-08-14 |
| NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. [68Ga]Ga-PSMA-11, [68Ga]GA-DOTA-TATE, [68Ga]Ga-NeoB - Metastatic Neuroendocrine Prostate Cancer | Phase 1 | Active not recruiting | Novartis Pharmaceuticals | 31 | 2024-07-29 | 2026-10-15 |
| The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global) 177Lu-TLX591, Enzalutamide, Abiraterone - Metastatic Castration-resistant Prostate Cancer | Phase 3 | Recruiting | Telix Pharmaceuticals (Innovations) Pty Limited | 520 | 2024-07-26 | 2026-07-21 |
| A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617, Androgen Deprivation Therapy (ADT) - Prostate Cancer Metastatic | Phase 3 | Recruiting | University College, London | 3360 | 2024-06-11 | 2025-09-26 |
| A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC AAA617, AAA517, Piflufolastat F 18 - Prostatic Neoplasm | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 49 | 2024-01-03 | 2026-10-21 |
| The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial Lutetium (177Lu) vipivotide tetraxetan - Adenoid Cystic Carcinoma | Phase 2 | Withdrawn | Maria Sklodowska-Curie National Research Institute of Oncology | 2024-01-01 | 2025-02-10 | |
| Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer AAA617 - Prostate Cancer | Phase 4 | Recruiting | Novartis Pharmaceuticals | 700 | 2023-08-14 | 2026-06-04 |
| An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors. Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide, long-acting Octreotide - Advanced Gastroenteropancreatic Neuroendocrine Tumor | Phase 3 | Recruiting | Jiangsu HengRui Medicine Co., Ltd. | 220 | 2023-07-06 | 2026-05-19 |
| Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs Lutetium [177Lu] oxodotreotide/dotatate - Gastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma | Phase 2 | Active not recruiting | Advanced Accelerator Applications | 11 | 2022-08-31 | 2026-02-12 |
| Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection Lutetium (177Lu) rhPSMA-10.1 Injection, 18F-rhPSMA-7.3 injection (in phase 1 only) - Prostate Cancer, Metastatic Castration-resistant Prostate Cancer | Phase 1 / Phase 2 | Recruiting | Blue Earth Therapeutics Ltd | 82 | 2022-07-20 | 2026-05-14 |
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Prostatic Neoplasms (7) · Gastro-enteropancreatic neuroendocrine tumor (3) · Neoplasms (3) · Neoplasms by Histologic Type (3) · AIDS-Related Complex (2) · Digestive System Neoplasms (2) · Immune System Diseases (2) · Lymphatic Diseases (2) · Lymphoma (2) · Lymphoma, Non-Hodgkin (2) · Lymphoproliferative Disorders (2) · Neuroendocrine Tumors (2) · Breast Neoplasms (1) · Carcinoma, Adenoid Cystic (1) · Digestive System Diseases (1)
Novartis Pharmaceuticals (6) · Blue Earth Therapeutics Ltd (2) · Maria Sklodowska-Curie National Research Institute of Oncology (2) · Nordic Nanovector (2) · Sichuan Baili Pharmaceutical Co., Ltd. (2) · Advanced Accelerator Applications (1) · Cellbion Co., Ltd. (1) · Emory University (1) · Fudan University (1) · Grupo Espanol de Tumores Neuroendocrinos (1) · Jiangsu HengRui Medicine Co., Ltd. (1) · Sociedad Española de Medicina Nuclear e Imagen Molecular (1) · Telix Pharmaceuticals (Innovations) Pty Limited (1) · University College, London (1)
United States (11) · Spain (9) · Germany (8) · United Kingdom (8) · France (5) · China (4) · Netherlands (4) · Poland (4) · Canada (3) · Belgium (2) · Czechia (2) · Italy (2) · South Korea (2) · Australia (1) · Austria (1)
Andreas Buck, Prof. MD (1) · Eric Baudin Baudin, M.D., Ph.D. (1) · Louise Brown (1) · Mercedes Dr Mitjavila Casanovas, MD-PhD (1) · Nick James (1) · Pretesh Patel, MD (1) · Timothy Illidge, PhD MB BS (1)
PMID 36877234, PMID 38164586, PMID 40198358
2023 (3), P30CA138292 (1)