A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor (SSTR)-positive tumors.

Start Date26 Sep 2025

Sponsor / Collaborator

ITM Solucin GmbH

NCT05918302

/ RecruitingPhase 3IIT

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-

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 Jul 2026·LANCET

[177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial

Article

Author: Garcia-Carbonero, Rocio ; Kollár, Attila ; Ćwikła, Jarosław B ; Baum, Richard P ; Walter, Thomas ; Del Olmo-García, Maribel ; Teulé, Alexandre ; Ansquer, Catherine ; Verberne, Hein J ; Breuninger, Monika ; Hörsch, Dieter ; Strosberg, Jonathan ; Melnyk, Serhii ; Jann, Henning ; Deshayes, Emmanuel ; Buck, Andreas ; Flaus, Anthime ; Grana, Chiara M ; Srirajaskanthan, Rajaventhan ; Michael, Michael ; Jimenez-Fonseca, Paula ; de Mestier, Louis ; Capdevila, Jaume ; Kluge, Andreas ; Zhernosekov, Konstantin ; Pavel, Marianne ; Rinke, Anja ; Dierickx, Lawrence O ; Hernando, Jorge

BACKGROUND:

Peptide receptor radionuclide and targeted therapy are both approved treatment options for patients with metastatic gastroenteropancreatic neuroendocrine tumours (GEP NETs), but clinical evidence for preferred sequencing is scarce. The COMPETE trial evaluated the efficacy and harms of peptide receptor radionuclide therapy ([¹⁷⁷Lu]Lu-edotreotide) versus targeted molecular therapy (everolimus) in patients with advanced, progressive, somatostatin receptor-positive GEP NETs.

METHODS:

This phase 3, open-label, superiority trial included patients aged 18 years or older with treatment-naive or previously treated unresectable or metastatic (or both) grade 1-2 GEP NETs. Patients were enrolled from 49 specialist neuroendocrine tumour treatment centres across 14 countries in Africa, Europe, North America, and Oceania and randomised (2:1) to intravenous [¹⁷⁷Lu]Lu-edotreotide (7·5 ± 0·7 GBq every 3 months, maximum four cycles) or oral everolimus (10 mg/day) for up to 30 months. Random assignment was via a central, web-based randomisation system (block size of 6) and stratified by primary tumour origin and previous therapy. The primary endpoint was progression-free survival, assessed via blinded independent central review in all randomly assigned patients at 30 months. Harms were assessed in all enrolled patients who received at least one dose of a study drug. This study was registered with ClinicalTrials.gov (NCT03049189) and is no longer recruiting.

FINDINGS:

Between April 13, 2017, and June 20, 2022, 324 patients were enrolled and 309 patients (including 168 [54%] male patients and 141 [46%] female patients) were randomly assigned to treatment: 207 to the [¹⁷⁷Lu]Lu-edotreotide group and 102 to the everolimus group. The median follow-up for progression-free survival was 27·5 months (IQR 19·6-30·4) for the [¹⁷⁷Lu]Lu-edotreotide group and 21·2 months (8·9-29·4) for the everolimus group. Median progression-free survival was significantly longer with [¹⁷⁷Lu]Lu-edotreotide versus everolimus (23·9 months [95% CI 18·7-30·0] vs 14·1 months [9·2-20·9]; stratified hazard ratio 0·67 [95% CI 0·48-0·95]; p=0·022). Treatment-related adverse events occurred in 178 (82%) of 217 patients in the [¹⁷⁷Lu]Lu-edotreotide group and 96 (97%) of 99 patients in the everolimus group. 40 (18%) patients in the [¹⁷⁷Lu]Lu-edotreotide group and 40 (40%) in the everolimus group had at least one treatment-related grade 3-4 adverse event. The most common treatment-related adverse events in the [¹⁷⁷Lu]Lu-edotreotide group were diarrhoea and nausea (both 79 [36%] patients) and asthenia (66 [33%] patients), whereas those in the everolimus group were diarrhoea (45 [45%] patients), asthenia (36 [36%] patients), and anaemia (27 [27%] patients). No treatment-related deaths occurred in either study group.

INTERPRETATION:

[¹⁷⁷Lu]Lu-edotreotide led to statistically significant and clinically meaningful improvements in progression-free survival. Efficacy and harms results support the use of [¹⁷⁷Lu]Lu-edotreotide in early lines of therapy in patients with advanced, progressive GEP NETs.

FUNDING:

ITM Solucin.

01 Mar 2026·JOURNAL OF NUCLEAR MEDICINE

Targeted β ⁻ -Particle Plus Conversion and Auger-Electron Therapy with ¹⁶¹ Tb-Labeled Somatostatin Receptor Antagonist DOTA-LM3: A Phase 0 Study

Article

Author: McDougall, Lisa ; Müller, Cristina ; Schmid, David E ; Westerbergh, Frida ; Geistlich, Susanne ; van der Meulen, Nicholas P ; Christ, Emanuel ; Bernhardt, Peter ; Nicolas, Guillaume P ; Fani, Melpomeni ; Fricke, Julia G ; Favaretto, Chiara ; Wild, Damian ; Schibli, Roger ; Borgna, Francesca

The goal of this phase 0 study was to determine the absorbed doses in tumors and relevant organs after a test injection of [¹⁶¹Tb]Tb-DOTA-LM3 and [¹⁷⁷Lu]Lu-DOTATOC in the same cohort of patients with grade 1 and 2 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Methods: In this randomized, crossover, prospective, single-center, open-label phase 0 study, 8 patients received 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3 and 1 GBq of [¹⁷⁷Lu]Lu-DOTATOC, with a 4-wk interval between injections. Quantitative SPECT/CT imaging was performed 3, 24, 72, and 168 h after administration of each radiopharmaceutical to calculate tumor and organ absorbed doses (3-dimensional dosimetry using a Monte Carlo-based ordered-subset expectation maximization algorithm). Results: After injection of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3, SPECT/CT revealed excellent image quality with intense tumor uptake in all patients and a median of the mean effective tumor half-life of 103 h (range, 56-152 h) for [¹⁶¹Tb]Tb-DOTA-LM3 and 83 h (range, 30-122 h) for [¹⁷⁷Lu]Lu-DOTATOC (P = 0.012). The medians of the mean tumor absorbed doses of [¹⁶¹Tb]Tb-DOTA-LM3 and [¹⁷⁷Lu]Lu-DOTATOC were 36.6 Gy/GBq (range, 15-196 Gy/GBq) and 7.0 Gy/GBq (range, 2.4-14.2 Gy/GBq), respectively (P = 0.008). The median kidney and bone marrow absorbed doses were 2.4 Gy/GBq (range, 1.8-3.1 Gy/GBq) and 0.31 Gy/GBq (range, 0.24-0.48 Gy/GBq) for [¹⁶¹Tb]Tb-DOTA-LM3 and 0.6 Gy/GBq (range, 0.4-0.8 Gy/GBq) and 0.04 Gy/GBq (range, 0.03-0.06 Gy/GBq) for [¹⁷⁷Lu]Lu-DOTATOC, respectively (both P = 0.008). According to Common Terminology Criteria for Adverse Events version 5.0, grade 1-3 treatment-emergent adverse events occurred in 6 of 8 patients after administration of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3. Conclusion: [¹⁶¹Tb]Tb-DOTA-LM3 showed a 7.6-fold-higher median tumor absorbed dose than that of [¹⁷⁷Lu]Lu-DOTATOC. The tumor-to-bone marrow absorbed dose ratio was in the same range for [¹⁶¹Tb]Tb-DOTA-LM3 as for [¹⁷⁷Lu]Lu-DOTATOC. The administration of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3 was safe for all patients, without relevant adverse events.

01 Oct 2025·CLINICAL NUCLEAR MEDICINE

Feasibility of Single Time Point Dosimetry Application in 177Lu-DOTATATE/DOTATOC-treated Pediatric Neuroblastoma

Article

Author: Zheng, Fei ; Yang, Hao ; Liu, Yuxuan ; Li, Pengfei ; Wang, Han ; Sun, Xingyao ; Sun, Xiaorong ; Sun, Yingying

Background::

177Lu-DOTATATE/DOTATOC peptide receptor radionuclide therapy (PRRT) has demonstrated potential for treating pediatric neuroblastoma (NB), and in clinical practice can be measured dosimetry by multi–time point (MTP) dosimetry. However, the high workload and limited patient compliance associated with MTP restrict its application. Consequently, single time point (STP) dosimetry approaches have emerged as a promising alternative, though their effectiveness in pediatric populations has not been thoroughly investigated. This study aimed to assess the dosimetric determination of 177Lu-DOTATATE/DOTATOC in pediatric neuroblastoma patients to determine whether STP could serve as a viable replacement for MTP.

Patients and Methods::

A total of 24 pediatric NB patients who received 1 to 2 cycles of 177Lu-DOTATATE or 177Lu-DOTATOC underwent dosimetric measurement of lesions and critical organs using the 96 hours single time point (STPH) dosimetry method proposed by Hänscheid and colleagues. The results were compared with those obtained from standard MTP.

Results::

In patients treated with 177Lu-DOTATATE, the mean relative deviation absolute values of the STPH-calculated absorbed dose from MTP were <10% for lesions, kidneys, bone marrow, liver, and spleen, with Pearson correlation coefficients of 0.99, 0.93, 0.97, 0.84, and 0.84, respectively. In patients treated with 177Lu-DOTATOC, the mean relative deviation absolute values for kidneys, spleen, and bone marrow were <10%, with Pearson correlation coefficients of 0.97, 0.77, 0.35, 0.48, and 0.93 for lesions, kidneys, bone marrow, liver, and spleen, respectively.

Conclusions::

The findings confirm that the 96 hours STPH method can reliably replace MTP for dosimetric assessment in pediatric NB patients treated with 177Lu-DOTATATE and performed well in renal dosimetry for 177Lu-DOTATOC therapy.

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

28 Sep 2026

·www.biospace.com

ITM and Lumara Bio Announce Real-World Re-treatment Data and Dosimetry Results from COMPETE for ¹⁷⁷Luedotreotide (ITM-11) in GEP-NETs at ASTRO 2026

Investigator-led SwissNET registry analysis showed longer real-world progression-free and overall survival for patients re-treated with 177 Lu-edotreotide compared to those receiving non-radiopharmaceutical systemic therapy Phase 3 COMPETE trial dosimetry analysis demonstrated favorable tumor-to-kidney absorbed dose ratio with low intra-patient variability Boston, Massachusetts, September 27 , 2026 — ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, and Lumara Bio , a dedicated oncology therapeutics division of ITM, today announced encouraging new data of non-carrier-added (n.c.a.) 177 Lu-edotreotide in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The findings were presented in two posters at the American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting, held from September 26 – 30, 2026 in Boston, Massachusetts. The first poster, presented by study author Dr. Julia G. Fricke, Physician-Scientist and Researcher in Nuclear Medicine & Theranostics at the University Hospital Basel, Switzerland, highlighted first-time, real-world re-treatment outcomes from an independent, retrospective analysis of adults in the SwissNET registry, a database of patients diagnosed with NETs in Switzerland. The analysis included 49 adults with metastatic, well-differentiated, somatostatin receptor (SSTR)-positive NETs who were re-treated with 177 Lu-edotreotide (n=37, Group A) or treated with a non-radiopharmaceutical systemic anti-cancer therapy (n=12, Group B) following disease progression ≥12 months after completing their initial 177 Lu-edotreotide treatment. Key findings included: Patients in Group A demonstrated a longer median real-world progression-free survival (rwPFS) of 12.5 months compared to 4.8 months for patients in Group B (p1) across all treatment cycles, suggesting that radiation delivery to lesions remains higher than to healthy organs “The real-world insights as well as the dosimetry data provide signals that radiopharmaceutical therapy represents an approach worth investigating in settings in which it has not yet been studied,” said Dr. Celine Wilke, chief medical officer of ITM . “Supported by these insights, we remain committed to ITM-11’s potential applications and pro GEP-NETs.” 177 Lu-edotreotide (ITM-11) is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. About the COMPETE Trial The COMPETE trial (NCT03049189) evaluated 177 Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177 Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177 Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs. 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. About Lumara Bio Lumara Bio, a division of ITM, builds on more than two decades of radiopharmaceutical expertise and is advancing a focused pipeline of targeted therapies for cancers where treatment options remain limited. 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 ITM Announces Re-treatment Data and Dosimetry Results from COMPETE at ASTRO 2026

Phase 3Clinical ResultASCOOligonucleotide

23 Sep 2026

·www.biospace.com

ITM and Lumara Bio Announce Upcoming Dosimetry and Re-treatment Data Presentations on ¹⁷⁷Lu-edotreotide at ASTRO 2026

Garching / Munich, September 23 , 2026 — ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, and Lumara Bio , a dedicated oncology therapeutics division of ITM, today announced that they will provide new data for Lu-edotreotide (ITM-11) in two poster presentations at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting, held from September 26 – 30, 2026 in Boston, Massachusetts. One poster will feature Phase 3 COMPETE trial dosimetry results for 177 Lu-edotreotide in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). A second poster will highlight findings from a registry analysis of re-treatment with 177 Lu-edotreotide in patients with progressive neuroendocrine tumors (NETs). Poster Presentation Details Title: 177 Lu-edotreotide Absorbed Dose in Patients with Gastroenteropancreatic Neuroendocrine Tumors: Dosimetry Results from COMPETE Abstract Number : 2100 Poster Board Number : 27 Poster Session : PQA 01: Gastrointestinal Cancer and Central Nervous System Date and Time : Sunday, September 27 , 2026, 3:00 – 4:00 PM ET Location : Poster Hall – Exhibit Hall A Presenter : Dr. Amir Iravani, University of California, Los Angeles, California Title: Re-treatment with 177 Lu-edotreotide in patients with progressive NETs: a SwissNet Registry Abstract Number : 2066 Poster Board Number : 27 Poster Session : PQA 01: Gastrointestinal Cancer and Central Nervous System Date and Time : Sunday, September 27 , 2026, 3:00 – 4:00 PM ET Location : Poster Hall – Exhibit Hall A Presenter : Dr. Julia G. Fricke, University Hospital Basel, Basel, Switzerland About the COMPETE Trial The COMPETE trial (NCT03049189) evaluated 177 Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177 Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177 Lu-edotreotide is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. 177 Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs. 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. About Lumara Bio Lumara Bio, a division of ITM, builds on more than two decades of radiopharmaceutical expertise and is advancing a focused pipeline of targeted therapies for cancers where treatment options remain limited. 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 ITM and Lumara Bio Announce Upcoming Dosimetry and Re-treatment Data Presentations on ¹⁷⁷Lu-edotreotide at ASTRO 2026

22 Sep 2026

·www.fiercebiotech.com

Novartis secures new radioligand in $900M deal as competition strengthens

As an imposing new competitor begins to take shape, radiopharma leader Novartis has beefed up its pipeline by licensing a preclinical radioligand therapy from a specialist Chinese biotech. BoomRay Therapeutics, based in the eastern city of Suzhou, can receive as much as $900 million from the Swiss drug giant, including an upfront payment as well as potential royalties and milestones tied to development, regulatory progress and sales. "Radioligand therapies represent an important frontier in oncology, and at Novartis, we remain focused on driving breakthrough science that can expand their potential for patients," Shiva Malek, Ph.D., Novartis’ global head of oncology biomedical research, said in a release. "Our agreement with BoomRay complements our growing radioligand therapy portfolio and reflects our strategy of combining external innovation with our cutting-edge research and development capabilities.” Details of the licensed program were not disclosed. BoomRay’s pipeline is led by a brain tumor diagnostic containing fluorine-18 as well as theranostics for solid tumors that target fibroblast activation protein and Nectin-4. “This agreement marks a significant milestone for BoomRay and is a strong validation of our discovery and development capabilities,” BoomRay CEO Bo Shan, Ph.D., said in the release. The pickup comes not long after Novartis ditched a midstage radioligand asset due to disappointing data. At the time of that July decision, Novartis CEO Vas Narasimhan told Fierce that the company’s commitment to the modality “remains completely unchanged.” Novartis dominates the radioligand market with Pluvicto and Lutathera, used to treat prostate cancer and neuroendocrine tumors respectively. But the field’s competitive landscape shifted dramatically yesterday when Australian radiopharma Telix Pharmaceuticals announced it was acquiring ITM Isotope Technologies, the supplier of the lutetium-177 isotope used in Pluvicto. Telix paid $1.65 billion upfront primarily to secure ITM’s lead radioligand candidate ITM-11, which was recently rejected by the FDA on manufacturing grounds. The drug was submitted for approval to treat gastroenteropancreatic neuroendocrine tumors, making it a direct rival to Lutathera. ITM plans to refile with the FDA, and solidifying a path to approval is a key condition for the Telix buyout to close. Analysts celebrated the merger, with William Blair experts noting the combined company could become a “global radiopharmaceutical powerhouse.”

AcquisitionDrug ApprovalLicense out/in

100 Deals associated with Lutetium (177Lu) edotreotide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastro-Enteropancreatic Neuroendocrine Tumor	NDA/BLA	United States	Itm Isotope Technologies Munich SE	14 Nov 2025
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	China	ITM Solucin GmbH	11 Feb 2025
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	China	Grand Pharmaceutical (China) Co., Ltd.	11 Feb 2025
Neuroendocrine neoplasm of lung	Phase 3	Belgium	Itm Isotope Technologies Munich SE	27 Oct 2023
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	Belgium	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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03049189 (COMPETE, Pubmed \| Lancet)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	[177Lu]Lu-edotreotide	fgeymxkgwy(tdprtyzglc) = yzrnvfltbv lzlhrkoojp (slkvlfixjb ) View more	Positive	01 Jul 2026
				Everolimus	fgeymxkgwy(tdprtyzglc) = keaacqxlgj lzlhrkoojp (slkvlfixjb ) View more
NCT03049189 (COMPETE, ASCO2026)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	177Lu-edotreotide	oqgwjnlrrk(kftjpmdqjn) = spllgpfmfm bxrzydxcul (kvskchwakx, -2.7 to 4.4) View more	Positive	29 May 2026
				Everolimus	oqgwjnlrrk(kftjpmdqjn) = ygnrdjudtu bxrzydxcul (kvskchwakx, -13.9 to -6.0) View more
NCT03049189 (COMPETE, CTgov)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	324	Amino-Acid Solution+177Lu-edotreotide PRRT (177Lu-edotreotide PRRT)	wgxluzmfsx(ifgisyulsc) = xlwdvocphp qxzuttfocq (pkverejjri, xduxpwbpqb - hwwsxdfdtr) View more	-	06 Apr 2026
				everolimus (Everolimus)	wgxluzmfsx(ifgisyulsc) = bowpryubqu qxzuttfocq (pkverejjri, vqgqnbgguz - rqlzerlrxp) View more
NCT03049189 (COMPETE, Company_Website) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor Second line \| First line Somatostatin Receptor Positive	309	177Lu-edotreotide	ydgrihfvfu(jtkdlludmv) = gvwycnjmyj cvpwcoiwaf (fbuofeuwgu ) Met View more	Positive	25 Oct 2025
				Everolimus	ydgrihfvfu(jtkdlludmv) = lmsnauljvr cvpwcoiwaf (fbuofeuwgu ) Met View more
NCT03049189 (COMPETE, Company_Website \| ESMO2025) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor Second line \| First line Somatostatin Receptor Positive	309	177Lu-edotreotide	nlpyoxdytw(qjzdcxcjpu) = mdybafdvun jqmkqhsugf (ytcypetmiz ) View more	Positive	18 Oct 2025
				Everolimus	nlpyoxdytw(qjzdcxcjpu) = yvfwcurnfd jqmkqhsugf (ytcypetmiz ) View more
NCT03049189 (COMPETE, ESMO2025)	Phase 3	somatostatin receptor positive \| Ki-67 ≤20%	309	177Lu-edotreotide	ehrvfboxva(rqnrfwphug) = xdmkarlzpz ieopsmfghe (hpghzqwbcv ) View more	Positive	17 Oct 2025
				Everolimus	ehrvfboxva(rqnrfwphug) = zwpyrmwnqf ieopsmfghe (hpghzqwbcv ) View more
NCT03049189 (COMPETE, EANM2025 \| GlobeNewswire) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	177Lu-edotreotide (ITM-11)	kpbjrksuaq(phylfvvkzm) = bkqtrldrxf qlowqxqzoh (vcleqjtjye ) Met View more	Positive	08 Oct 2025
				Everolimus	kpbjrksuaq(phylfvvkzm) = jplpzptvhk qlowqxqzoh (vcleqjtjye ) Met View more
NCT05918302 (LEVEL/GETNE-t2217, ESPE2025)	Phase 3	Neuroendocrine Tumors	120	177Lu-edotreotide	msiupfclux(hyomrtgpqm) = skfrqruiwz lugriomlxq (idaayhbrmn )	Positive	10 May 2025
NCT03049189 (COMPETE, Company_Website \| NEWS) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	ITM-11	tphlzmmczl(jmeykqsrou) = arztvfgksw fhcqpmcxko (mgfzhztolc ) Met View more	Positive	28 Jan 2025
				Everolimus	tphlzmmczl(jmeykqsrou) = vjpxnxilgw fhcqpmcxko (mgfzhztolc ) Met View more
NCT04194125 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Neuroendocrine Tumors	21	177Lu DOTATOC+ CAPTEM	yphhhggfbn(bddbdwhovb) = piwevmuqud oelsrgipor (sbqktqjutc, 16.0 - NR) View more	Positive	22 Oct 2023
				177Lu DOTATOC+ CAPTEM (panNET)	yphhhggfbn(bddbdwhovb) = jefyclqlps oelsrgipor (sbqktqjutc, 14.0 - NR)

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