Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy with 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.

Start Date27 Oct 2023

Sponsor / Collaborator

Itm Isotope Technologies Munich SE

NCT06045260

/ RecruitingPhase 2

"Receptor Radionuclide Therapy With 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR Positive Patients: a Multicenter, Prospective, Phase II Trial"

Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas...). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.

Start Date13 Sep 2023

Sponsor / Collaborator-

NCT05359146

/ RecruitingEarly Phase 1IIT

Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3): Beta Plus Study

The goal of this phase 0 proof-of concept study is to measure the therapeutic index (tumour to dose-limiting-organ dose ratios) of 161Tb-DOTA-LM3 in comparison to the current standard 177Lu-DOTATOC in the same gastroenteropancreatic neuroendocrine tumour (GEP-NET) patients in a randomized, cross-over design, in all patients.
Population to be studied are patients with diagnosed and metastasized secreting and non-secreting GEP-NEN (grade 1 and 2). The number of participants will be limited to 4 - 8 patients (phase 0a) and 4 - 8 patients (phase 0b). All patients will get the same treatment in a balanced cross-over order. The study will be divided into a phase 0a and phase 0b. Beforehand the selected patients will be randomised into two groups. In phase 0a one test injection with 161Tb-DOTA-LM3 and 177Lu-DOTATOC will administered in both randomised groups in a different order followed by
3 cycles PRRT with 177Lu-DOTATOC in both groups. In phase 0b two test injections with 161Tb-DOTA-LM3 (with different peptide amounts) will administered in both randomised groups in a different order followed by
2 cycles PRRT with 161Tb-DOTA-LM3 in both groups.

Start Date28 Mar 2023

Sponsor / Collaborator

Universitätsspital Basel

[+2]

100 Clinical Results associated with Lutetium (177Lu) edotreotide

100 Translational Medicine associated with Lutetium (177Lu) edotreotide

100 Patents (Medical) associated with Lutetium (177Lu) edotreotide

Literatures (Medical) associated with Lutetium (177Lu) edotreotide

01 Jun 2024·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Safety and Efficacy ofPara-Aminohippurate Coinfusion for Renal Protection During Peptide Receptor Radiotherapy in Patients with Neuroendocrine Tumors

Article

Author: Jentzen, Walter ; Meckel, Marian ; van Echteld, Cees J A ; Himmen, Stephan ; Fendler, Wolfgang P ; Coelho, Marta ; Fragoso Costa, Pedro ; Sraieb, Miriam ; Herrmann, Ken ; Moraitis, Alexandros ; Kersting, David

Para-aminohippurate, also known as p-aminohippuric acid (PAH), is used clinically to measure effective renal plasma flow. Preclinically, it was shown to reduce ¹⁷⁷Lu-DOTATOC uptake in the kidneys while improving bioavailability compared with amino acid (AA) coinfusion. We report the safety and efficacy of PAH coinfusion during peptide receptor radiotherapy in patients with neuroendocrine tumors. Methods: Twelve patients with metastatic or unresectable gastroenteropancreatic neuroendocrine tumors received ¹⁷⁷Lu-DOTATOC in 33 treatment cycles. Either 8 g of PAH or a mixture of 25 g of arginine and 25 g of lysine were coinfused. Safety was assessed by monitoring laboratory data, including hematologic and renal data, as well as electrolytes obtained before and 24 h after treatment. For radiation dosimetry, whole-body scans were performed at 1, 24, and 48 h and a SPECT/CT scan was performed at 48 h, along with blood sampling at 5 min and 0.5, 2, 4, 24, and 48 h after administration. Absorbed dose estimations for the kidneys and bone marrow were performed according to the MIRD concept. Results: In 15 treatment cycles, PAH was coinfused. No changes in mean creatinine level, glomerular filtration rate, and serum electrolytes were observed before or 24 h after treatment when using PAH protection (P ≥ 0.20), whereas serum chloride and serum phosphate increased significantly under AA (both P < 0.01). Kidney-absorbed dose coefficients were 0.60 ± 0.14 Gy/GBq with PAH and 0.53 ± 0.16 Gy/GBq with AA. Based on extrapolated cumulative kidney-absorbed doses for 4 cycles, 1 patient with PAH protection and 1 patient with AA protection in our patient group would exceed the 23-Gy conservative threshold. The bone marrow-absorbed dose coefficient was 0.012 ± 0.004 Gy/GBq with PAH and 0.012 ± 0.003 Gy/GBq with AA. Conclusion: PAH is a promising alternative to AA for renal protection during peptide receptor radiotherapy. Further research is required to systematically investigate the safety profile and radiation dosimetry at varying PAH plasma concentrations.

01 Jan 2024·Theranostics

Long-term Nephrotoxicity after PRRT: Myth or Reality

Article

Author: Yu, Fei ; Zhang, Jingjing ; Baum, Richard P ; Schuchardt, Christiane ; Fan, Xin ; Chen, Xiaoyuan ; Jakobsson, Vivianne

Rationale: The kidneys are commonly considered as the potential dose-limiting organ for peptide receptor radionuclide therapy (PRRT), making the risk of nephrotoxicity a primary concern. This retrospective analysis with prospective documentation and long-term follow-up aims to assess the risk of nephrotoxicity after PRRT in a large cohort of patients with neuroendocrine neoplasms (NENs) treated at our institution over the past 18 years. Methods: A total of 1361 NEN patients treated with 1-10 cycles of ¹⁷⁷Lu-DOTA-TOC/-NOC/-TATE, ⁹⁰Y-DOTA-TOC/-NOC/-TATE, DUO-PRRT (sequential administration of ⁹⁰Y- and ¹⁷⁷Lu-), or TANDEM-PRRT (combination of ⁹⁰Y- and ¹⁷⁷Lu- on the same day concomitantly) were included in this analysis. All parameters were prospectively documented in a structured database comprising over 250 items per patient and retrospectively analyzed. Kidney function, including serum creatinine, blood urea nitrogen, cGFR, and electrolytes, was evaluated before each PRRT cycle and during follow-up. Restaging was regularly performed at 6-month intervals until death. Treatment-related adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). Results: Between 2000 and 2018, a total of 5409 cycles of PRRT were administered to 1361 NEN patients. Follow-up after complete treatment was available for 1281 patients receiving 4709 cycles of PRRT, with a median follow-up time of 69.2 months (interquartile range, 32.8-110.5 months) and a maximum follow-up time of 175 months. Baseline creatinine levels were normal in 1039/1281 (81.1%) subjects, while grade 1 (G1) renal insufficiency was present in 221/1281 (17.3%) prior to PRRT. G2 was present in 19/1281 (1.5%), and G3 in 2/1281 (0.2%). After treatment, the proportion of G3/G4 grade patients only increased from 0.2% to 0.7%. Mean creatinine levels increased from a baseline of 0.90 ± 0.30 to 1.01 ± 0.57 mg/L (80.0 ± 26.7 to 89.4 ± 50.8 μmol/L) after treatment. In our main analysis cohort of 1244 patients (4576 cycles), 200 patients experienced an increase in CTCAE creatinine grade. Age, number of treatment cycles, type of radionuclides, and length of follow-up time were the main factors affecting CTCAE creatinine grading after treatment. When comparing the subgroups treated with different radionuclides, the risk of nephrotoxicity after ⁹⁰Y treatment alone and the ⁹⁰Y/¹⁷⁷Lu combination group was higher than after ¹⁷⁷Lu treatment alone. In the ⁹⁰Y treatment subgroup, the two significant risk factors for an increased CTCAE creatinine grade were identified to be age (≥60) and a long follow-up time. Conclusions: This retrospective analysis with prospective documentation in a large cohort of 1281 NEN patients receiving 4709 cycles of PRRT co-administered with renal protection, treated through the individualized approach at a single institution over 18 years, did not reveal any evidence of long-term PRRT-related renal toxicity. The results of our study suggest that with the use of proper renal protection, nephrotoxicity due to PRRT is more likely a myth than a reality.

01 Jul 2023·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of ¹⁶¹Tb into the Clinic.

Article

Author: Landolt, Stefan ; van der Meulen, Nicholas P ; Grundler, Pascal V ; Talip, Zeynep ; Köster, Ulli ; Sepini, Lebogang ; Schibli, Roger ; Favaretto, Chiara ; Geistlich, Susanne ; Müller, Cristina

¹⁶¹Tb is an interesting radionuclide for application in the treatment of neuroendocrine neoplasms' small metastases and single cancer cells because of its conversion and Auger-electron emission. Tb has coordination chemistry similar to that of Lu; therefore, like ¹⁷⁷Lu, it can stably radiolabel DOTATOC, one of the leading peptides used for the treatment of neuroendocrine neoplasms. However, ¹⁶¹Tb is a recently developed radionuclide that has not yet been specified for clinical use. Therefore, the aim of the current work was to characterize and specify ¹⁶¹Tb and to develop a protocol for the synthesis and quality control of ¹⁶¹Tb-DOTATOC with a fully automated process conforming to good-manufacturing-practice guidelines, in view of its clinical use. Methods: ¹⁶¹Tb, produced by neutron irradiation of ¹⁶⁰Gd in high-flux reactors followed by radiochemical separation from its target material, was characterized regarding its radionuclidic purity, chemical purity, endotoxin level, and radiochemical purity (RCP) in analogy to what is described in the European Pharmacopoeia for no-carrier-added ¹⁷⁷Lu. In addition, ¹⁶¹Tb was introduced into a fully automated cassette-module synthesis to produce ¹⁶¹Tb-DOTATOC, as used for ¹⁷⁷Lu-DOTATOC. The quality and stability of the produced radiopharmaceutical in terms of identity, RCP, and ethanol and endotoxin content were assessed by means of high-performance liquid chromatography, gas chromatography, and an endotoxin test, respectively. Results: ¹⁶¹Tb produced under the described conditions showed, as the no-carrier-added ¹⁷⁷Lu, a pH of 1-2, radionuclidic purity and RCP of more than 99.9%, and an endotoxin level below the permitted range (175 IU/mL), indicating its appropriate quality for clinical use. In addition, an efficient and robust procedure for the automated production and quality control of ¹⁶¹Tb-DOTATOC with clinically applicable specifications and activity levels, that is, 1.0-7.4 GBq in 20 mL, was developed. The radiopharmaceutical's quality control was also developed using chromatographic methods, which confirmed the product's stability (RCP ≥ 95%) over 24 h. Conclusion: The current study demonstrated that ¹⁶¹Tb has appropriate features for clinical use. The developed synthesis protocol guarantees high yields and safe preparation of injectable ¹⁶¹Tb-DOTATOC. The investigated approach could be translated to other DOTA-derivatized peptides; thus, ¹⁶¹Tb could be successfully applied in clinical practice for radionuclide therapy.

News (Medical) associated with Lutetium (177Lu) edotreotide

27 May 2025

·www.einpresswire.com

ITM Secures Up to $262.5m in Non-dilutive Debt Financing with Blue Owl Managed Funds

Debt capital to support commercial readiness and potential U.S. launch of n.c.a. 177 Lu-edotreotide (ITM-11), following positive Phase 3 results Flexible funding structure enables continued advancement of ITM’s targeted radiopharmaceutical pipeline and leading radioisotope manufacturing business Garching / Munich, Germany, May 27, 2025 – ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today announced a debt financing agreement for up to USD 262.5 million from funds managed by Blue Owl Capital, Inc (“Blue Owl”). The capital will be used to prepare for commercial readiness and potential market launch of the company’s lead candidate, n.c.a. 177 Lu-edotreotide (also known as ITM-11 or 177 Lu-edotreotide). ITM-11 recently met the primary endpoint in the COMPETE Phase 3 study as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM plans to submit a New Drug Application (NDA) for this asset to the U.S. FDA in 2025. In addition, the company will continue to accelerate the development of its innovative targeted radiopharmaceutical pipeline and the scale-up of Actinium-225 manufacturing through its joint venture, Actineer. Under the terms of the agreement, ITM will receive USD 140 million upon closing and can exercise additional tranches. Further details of the agreement have not been disclosed. “ Blue Owl is a highly regarded investor with a deep appreciation for the potential of radiopharmaceuticals, and we see their debt capital for ITM as a validation of our position as a cornerstone of the radiopharmaceutical industry ,” said Dr. Andrew Cavey, CEO of ITM . “ This strategic funding agreement enables us to move rapidly toward the potential U.S. commercialization of ITM-11, subject to FDA approval, and provides flexibility for the development and expansion of our innovative pipeline of targeted radiopharmaceuticals across a broad range of indications .” “ With its vertically integrated approach that combines a profitable radioisotope manufacturing business with radiopharmaceutical pipeline development, we believe ITM is uniquely positioned to positively impact the precision oncology sector. We look forward to supporting ITM’s continued growth and mission to bring innovative treatment options to people living with cancer ,” said Sandip Agarwala, Managing Director and Head of Life Sciences at Blue Owl . About n.c.a. 177 Lu-edotreotide (ITM-11) 177 Lu-edotreotide is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. The drug candidate, delivered intravenously, is comprised of non-carrier-added Lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. 177 Lu-edotreotide was granted orphan drug designation in the E.U. and the U.S., and fast track designation in the U.S. for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study with 177 Lu-edotreotide. About ITM Isotope Technologies Munich SE ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply of medical radioisotopes. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com About Blue Owl Blue Owl (NYSE: OWL) is a leading asset manager that is redefining alternatives ® . With $273 billion in assets under management as of March 31, 2025, Blue Owl invests across three multi-strategy platforms: Credit, GP Strategic Capital, and Real Assets. Anchored by a strong permanent capital base, we provide businesses with private capital solutions to drive long-term growth and offer institutional investors, individual investors, and insurance companies differentiated alternative investment opportunities that aim to deliver strong performance, risk-adjusted returns, and capital preservation. Together with over 1,200 experienced professionals globally, Blue Owl brings the vision and discipline to create the exceptional. To learn more, visit www.blueowl.com . ITM Contact Corporate Communications Kathleen Noonan/Julia Westermeir Phone: +49 89 329 8986 1500 Email: communications@itm-radiopharma.com Investor Relations Ben Orzelek Phone: +49 89 329 8986 1009 Email: investors@itm-radiopharma.com Attachment 20250527_ITM Secures Up to $262.5m in Non-dilutive Debt Financing with Blue Owl Managed Funds Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultPhase 3Orphan DrugPhase 2Fast Track

27 May 2025

·firstwordpharma.com

ITM lands $262.5M debt deal to fund targeted radiotherapy in GEP-NETs

ITM Isotope Technologies said Tuesday it secured up to $262.5 million in debt financing to help advance its lead cancer treatment toward potential US commercialisation. Specifically, the non-dilutive financing from Blue Owl Capital will support preparation for the market launch of ITM-11 (177Lu-edotreotide) following positive results from the Phase III COMPETE trial.The study demonstrated that ITM-11 significantly outperformed Novartis' Afinitor (everolimus) in treating patients with Grade 1 or 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), extending median progression-free survival to 23.9 months compared with 14.1 months for the established therapy. That translated to a 33% reduction in the risk of disease progression or death, with ITM-11 also demonstrating a more favourable safety profile, according to results unveiled in March.ITM reiterated plans to submit a filing to the FDA in 2025. ITM-11 — which combines the therapeutic β-emitting radioisotope lutetium-177 with the synthetic SSTR agonist edotreotide — is also being investigated in the Phase III COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or 3 SSTR-positive GEP-NETs.The German radiopharmaceutical biotech will receive $140 million upon closing the Blue Owl agreement, with additional tranches available as needed."This strategic funding agreement enables us to move rapidly toward the potential US commercialisation of ITM-11, subject to FDA approval, and provides flexibility for the development and expansion of our innovative pipeline of targeted radiopharmaceuticals across a broad range of indications," stated CEO Andrew Cavey.The radiopharmaceuticals space has gained momentum following successful launches by companies like Novartis, which already markets the radionuclide therapy Lutathera (lutetium Lu 177 dotatate) for GEP-NETs that are positive for the somatostatin receptor. Lutathera brought in sales of $724 million last year.Something that differentiates ITM from other players, however, is that it has worked in the radiopharma space for over 20 years and has manufacturing in-house, in addition to its drug development programmes, a combination that has attracted backing from previous investors including Temasek and BlackRock in earlier funding rounds totalling about €615 million ($700 million) since 2022.

Phase 3Clinical ResultFinancial StatementOligonucleotide

09 Apr 2025

·www.globenewswire.com

Barbara Weber, M.D., Elected to ITM Supervisory Board

Garching / Munich, Germany, April 09, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the election of Barbara Weber, M.D., to its Supervisory Board, effective May 01, 2025. The election occurred at ITM’s Extraordinary General Meeting. Dr. Weber is the President, Chief Executive Officer and Founder of Tango Therapeutics (Nasdaq: TNGX). She has over 25 years of executive and research and development leadership experience in biotech, venture capital and at major pharmaceutical companies, including Novartis (NYSE: NVS) and GlaxoSmithKline (NYSE: GSK). ITM’s Supervisory Board and the company overall will benefit from Dr. Weber’s deep expertise as it advances its lead Phase 3 candidate, n.c.a. 177Lu-edotreotide (ITM-11), and continues advancing its radiopharmaceutical pipeline and medical radioisotope manufacturing business. “Dr. Weber’s impressive track record in building transformative oncology biotech companies speaks volumes for her business acumen and her dedication to improving the lives of people living with cancer. Her profound industry and scientific knowledge, including her demonstrated ability to bring novel compounds through the clinic to FDA approval, will be an invaluable asset to ITM,” said Udo J. Vetter, Chairman of the Supervisory Board of ITM. “The expansion of our Supervisory Board and its insights ensures that ITM is optimally positioned to continue accelerating the growth of its radiopharmaceutical pipeline and medical radioisotope business.” Dr. Weber is a physician-scientist with a distinguished clinical and academic career and extensive leadership expertise in global pharmaceutical development. As the President, Chief Executive Officer and Founder of Tango Therapeutics, she led the company’s transition to being publicly listed and the development of its precision oncology product candidates based on the genetic principle of synthetic lethality. As a Venture Partner at Third Rock Ventures, she led teams in creating new oncology drug discovery companies, including Tango Therapeutics, Neon Therapeutics (acquired by BioNTech (Nasdaq: BNTX)) and Relay Therapeutics (Nasdaq: RLAY). “As a physician and business executive devoted to fighting cancer, I recognize the significant potential of targeted radiopharmaceutical therapy to improve the precision oncology treatment paradigm and outcomes for patients. I look forward to working with ITM’s Supervisory Board and Leadership Team as the company plans an NDA submission for ITM-11 and expands its pipeline with various promising alpha- and beta-emitting radioisotopes coupled with novel targeting agents,” said Dr. Weber. Prior to her tenure at Third Rock Ventures, Dr. Weber was Senior Vice President, Oncology Translational Medicine at Novartis and Vice President, Oncology Discovery and Translational Medicine at GlaxoSmithKline, where she was instrumental in leading clinical studies and obtaining FDA approvals for numerous drugs including Zykadia®, Kisqali®, Vijoice® and Promacta®. Dr. Weber received her Doctor of Medicine from the University of Washington and has been affiliated with the University of Pennsylvania, Yale University and the Dana-Farber Cancer Institute. She is a member of the Board of Directors at Tango Therapeutics, Revolution Medicines Inc. (Nasdaq: RVMD), Parabilis Medicines and Sesame Therapeutics. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.com Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachments 20250409_Barbara Weber, M.D., Elected to ITM Supervisory Board Barbara Weber, M.D., Elected to ITM Supervisory Board

Executive ChangePhase 3

100 Deals associated with Lutetium (177Lu) edotreotide

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Indication	Highest Phase	Country/Location	Organization	Date
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	China	Grand Pharmaceutical (China) Co., Ltd.	11 Feb 2025
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	China	ITM Solucin GmbH	11 Feb 2025
Neuroendocrine neoplasm of lung	Phase 3	France	Itm Isotope Technologies Munich SE	27 Oct 2023
Neuroendocrine neoplasm of lung	Phase 3	Italy	Itm Isotope Technologies Munich SE	27 Oct 2023
Neuroendocrine neoplasm of lung	Phase 3	Spain	Itm Isotope Technologies Munich SE	27 Oct 2023
Somatostatin Receptor-Positive Neuroendocrine Tumor	Phase 3	France	Itm Isotope Technologies Munich SE	27 Oct 2023
Somatostatin Receptor-Positive Neuroendocrine Tumor	Phase 3	Italy	Itm Isotope Technologies Munich SE	27 Oct 2023
Somatostatin Receptor-Positive Neuroendocrine Tumor	Phase 3	Spain	Itm Isotope Technologies Munich SE	27 Oct 2023
Thymus Neoplasms	Phase 3	France	Itm Isotope Technologies Munich SE	27 Oct 2023
Thymus Neoplasms	Phase 3	Italy	Itm Isotope Technologies Munich SE	27 Oct 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03049189 (COMPETE, Company_Website \| NEWS) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	ITM-11	sfjvoujfgy(qhzenjevbm) = mqlqjlzygu qybnpuceje (otvyutsomy ) Met View more	Positive	28 Jan 2025
NCT03049189 (COMPETE, Company_Website \| NEWS) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	Everolimus	sfjvoujfgy(qhzenjevbm) = yadrglfyil qybnpuceje (otvyutsomy ) Met View more	Positive	28 Jan 2025
NCT04194125 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Neuroendocrine Tumors	21	177Lu DOTATOC+ CAPTEM	pczcfjkrkp(jqnufdtlix) = axhtzigbdi dchcebnkgy (gngjbcncyu, 16.0 - NR) View more	Positive	22 Oct 2023
NCT04194125 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Neuroendocrine Tumors	21	177Lu DOTATOC+ CAPTEM (panNET)	pczcfjkrkp(jqnufdtlix) = vtclhaeycr dchcebnkgy (gngjbcncyu, 14.0 - NR)	Positive	22 Oct 2023
SNMMI2023	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor	-	4 cycles of PRRT	nddqklrksg(nudhzxslre) = 27 of these 36 patients (75%; 14 SI-NET; 4 CUP-NET; 9 P-NET) experienced PD in iStaging zhpbugzbwc (lzforudqwf ) View more	-	28 Aug 2023
SNMMI2022	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor	-	[177Lu]DOTATOC (GEP-NET patients)	vmxibozuva(qylxladdqp) = wimjukammk nvcqsbkzoi (jitsgkjrci ) View more	-	08 Aug 2022
EANM2019	Not Applicable	-	-	Extravasation of Lutetium-177-Dotatoc	yrhrrdypcj(fbuhytjplo) = Action was now taken as to confirm an extravasal injection kzditlxeba (rxdbedgzga )	-	18 Sep 2019
SNMMI2019	Not Applicable	-	-	Lu-177 DOTA-LM3	ygadsiiyke(hciqbwucuy) = jyylwuwzzz otwclucuod (gmpghkjtoi ) View more	-	21 May 2019
SNMMI2019	Not Applicable	-	-	Lu-177 DOTATOC	ygadsiiyke(hciqbwucuy) = gvorglckfp otwclucuod (gmpghkjtoi ) View more	-	21 May 2019
NCT03049189 (COMPETE, ESMO2018)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	300	Everolimus	xpmsfdyvko(lzdbdnkgmy) = bnsnhwlmor jxbelkyruv (pphecclrke )	-	21 Oct 2018
PRRT using Lu-177 DOTA-LM3 (EANM2018)	Not Applicable	Ga-68 NODAGA-LM3 PET/CT	-	Lu-177 DOTA-LM3	orntxndckz(zbpehspfwt) = odwfklutox jluzujlqpz (igvftdrbow ) View more	Positive	18 Sep 2018
PRRT using Lu-177 DOTA-LM3 (EANM2018)	Not Applicable	Ga-68 NODAGA-LM3 PET/CT	-	Lu-177 DOTATOC	orntxndckz(zbpehspfwt) = jlorgtnqjh jluzujlqpz (igvftdrbow ) View more	Positive	18 Sep 2018
EANM2016	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor	-	n.c.a. Lu-177 DOTA-TATE	dzauohsadp(zbqcaprsua) = zlqtpysxep kckhrxnuzw (pcmqolswex )	-	21 Sep 2016

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