Lutetium-177 clinical trials
How each study uses Lutetium-177 is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Get an email when these change. Save the Lutetium-177 studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.
See an example email
Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
One email a week for all your saved searches. Stop any time.
Approvals
The first approval found in each region, with its record
- United States
- Not in FDA's approval records
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
41 studies that test it; most in 2024 (11)
| Year | Studies |
|---|---|
| 2009 | 1 |
| 2022 | 5 |
| 2023 | 8 |
| 2024 | 11 |
| 2025 | 6 |
| 2026 | 10 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 24 · Other 17
Novartis Pharmaceuticals (9) · Sinotau Pharmaceutical Group (3) · Beijing Tiantan Hospital (2) · Blue Earth Therapeutics Ltd (2) · Sichuan Baili Pharmaceutical Co., Ltd. (2) · Nantes University Hospital (1) · Providence Health & Services (1) · Advanced Accelerator Applications (1)
Often tested with
Tested in the same studies.
Capecitabine (1) · Lutetium Lu 177 dotatate (1) · Metoclopramide (1) · Cabozantinib (1) · Imp-288 (1) · Indium-111 (1) · Actinium-225 (1) · Gallium-68 (1)
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 12, 2 in phase 3
Studies that test Lutetium-177, phase 3 first.
- Dec 2026An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.Phase 3 · Jiangsu HengRui Medicine Co., Ltd.
- Jun 2027A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine NeoplasmsPhase 2/3 · Sinotau Pharmaceutical Group
- Dec 2026[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast CancerPhase 1 · Novartis Pharmaceuticals
- Dec 2026[177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade GliomaEarly Phase 1 · Beijing Tiantan Hospital
- Jan 2027A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast CancerPhase 1 · Affibody
- Apr 2027Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate CancerPhase 2 · Hospices Civils de Lyon
- Apr 2027A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.Phase 1/2 · Novartis Pharmaceuticals
- Jun 2027Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent GlioblastomaEarly Phase 1 · Beijing Tiantan Hospital
- Aug 2027Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent GlioblastomaPhase 1 · Novartis Pharmaceuticals
- Sep 2027Safety and Preliminary Efficacy of [177Lu]Lu-RTX-2358 Combined With Immune Checkpoint Inhibitors in Patients With FAP-positive Metastatic Non-Small Cell Lung CancerEarly Phase 1 · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Studies
Open first, then newest update. How each study uses Lutetium-177 is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 41
- Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate CancerRecruitingPhase 1/2Sinotau Pharmaceutical GroupNCT06081686Written as Phase I:[177Lu]Lu-XT033 Injection
- Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior TreatmentRecruitingPhase 2RTOG Foundation, Inc.NCT06955169Written as [177Lu]Lu-DOTATATE
- Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid TumorsRecruitingPhase 1Novartis PharmaceuticalsNCT07660055Written as [177Lu]Lu-DWJ155
- A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid TumorsRecruitingPhase 1Philogen S.p.A.NCT06640413Written as [177Lu]Lu-OncoFAP-23
- Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate CancerRecruitingPhase 1Cellbion Co., Ltd.NCT07244393Written as Lutetium (177Lu) DGUL
- A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid TumorsRecruitingPhase 1Alpha-9 Oncology USA Inc.NCT07661641Written as [177Lu]Lu-A9-0631
- Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow FunctionRecruitingPhase 4M.D. Anderson Cancer CenterNCT07169825Written as Lu-177
- Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal CancersRecruitingPhase 1Novartis PharmaceuticalsNCT06562192Written as [177Lu]Lu-NNS309
- A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine NeoplasmsRecruitingPhase 2/3Sinotau Pharmaceutical GroupNCT06398444Written as Lutetium[177Lu] Oxodotreotide Injection
- Safety and Preliminary Efficacy of [177Lu]Lu-RTX-2358 Combined With Immune Checkpoint Inhibitors in Patients With FAP-positive Metastatic Non-Small Cell Lung CancerRecruitingEarly Phase 1Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT07689643Written as [177Lu]Lu-RTX-2358
- [177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade GliomaRecruitingEarly Phase 1Beijing Tiantan HospitalNCT07655869Written as [177Lu]Lu-DOTA-EB-RGD2
- Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent GlioblastomaRecruitingEarly Phase 1Beijing Tiantan HospitalNCT07648823Written as [177Lu]Lu-XT771
- First-in-human Diagnostic Imaging Profile of the Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu] Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic CancerRecruitingEarly Phase 1Integrated Haematology and Oncology NetworkNCT07608848Written as [177Lu]Lu-DOTA-STR-17126
- An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.RecruitingPhase 3Jiangsu HengRui Medicine Co., Ltd.NCT05884255Written as Lutetium (177Lu) Oxodotreotide Injection;long-acting Octreotide
- Anti-tumour Activity of (177Lu) rhPSMA-10.1 InjectionRecruitingPhase 1/2Blue Earth Therapeutics LtdNCT05413850Written as Lutetium (177Lu) rhPSMA-10.1 Injection
- [177Lu]Lu-AKIR001 First-in-human StudyRecruitingEarly Phase 1Karolinska University HospitalNCT06639191Written as [177Lu]Lu-AKIR001
- A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid TumorsRecruitingPhase 1Sichuan Baili Pharmaceutical Co., Ltd.NCT07232407Written as Lutetium [177Lu] BL-ARC001
- Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate CancerRecruitingPhase 2Hospices Civils de LyonNCT06866938Written as [177Lu]Lu-PSMA-617 (Pluvicto, Novartis)
- 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 TumorsRecruitingPhase 1Sichuan Baili Pharmaceutical Co., Ltd.NCT07274852Written as Lutetium [177Lu] BL-ARC001
- A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced CancerRecruitingPhase 1/2Spago Nanomedical ABNCT06184035Written as [177Lu]Lu-SN201
Codes
What other systems call Lutetium-177 · ClinicalTrials.gg INT000625
- MeSH (NLM) C000615061Lutetium-177Confirmed ClinicalTrials.gov, NLM
- UNII (FDA) BRH40Y9V1QLUTETIUM LU-177Confirmed NLM, Wikidata
- Wikidata Q18882670lutetium-177Confirmed NLM, Wikidata
- DrugBank DB13982One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000615061 | Lutetium-177 | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | BRH40Y9V1Q | LUTETIUM LU-177 | Confirmed NLM, Wikidata |
| Wikidata | Q18882670 | lutetium-177 | Confirmed NLM, Wikidata |
| DrugBank | DB13982 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.