PRRT for Neuroendocrine Tumors
(COMPOSE Trial)
Recruiting in Palo Alto (17 mi)
+42 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: ITM Solucin GmbH
Disqualifiers: Other malignancies, Serious diseases, Organ dysfunction, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment that uses a radioactive drug to target and kill specific cancer cells in patients with certain types of neuroendocrine tumors. It aims to see if this method is more effective and safer than current treatments.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on an investigational drug, you must stop it at least 30 days before joining the trial.
What data supports the effectiveness of the treatment 177Lu-Edotreotide for neuroendocrine tumors?
Research shows that a similar treatment, 177Lu-DOTATATE, is effective for neuroendocrine tumors that express somatostatin receptors, providing symptomatic and radiological improvements in patients with inoperable or metastatic tumors.
12345Is 177Lu-Edotreotide PRRT generally safe for humans?
177Lu-Edotreotide PRRT is generally considered safe, but it can have side effects like potential toxicity to the kidneys, liver, and blood cells, and there is a risk of developing a second cancer. These side effects have been observed in studies, even though the treatment is effective for certain types of tumors.
12367How is the treatment 177Lu-Edotreotide different from other treatments for neuroendocrine tumors?
177Lu-Edotreotide is a type of peptide receptor radionuclide therapy (PRRT) that uses a radioactive substance to target and bind to specific receptors on neuroendocrine tumor cells, delivering radiation directly to the tumor. This approach is unique because it combines a targeted delivery system with radiation therapy, potentially offering a more focused treatment with fewer side effects compared to traditional chemotherapy.
12489Eligibility Criteria
This trial is for adults with aggressive, well-differentiated GEP-NETs that can't be surgically removed and have shown up on scans. Participants must have tumors with somatostatin receptors but cannot join if they're pregnant, breastfeeding, hypersensitive to the drugs being tested, recently had major surgery or other cancer treatments, or have serious health issues affecting their organs.Inclusion Criteria
My GEP-NETs cancer is confirmed and can't be removed by surgery.
I am 18 years old or older.
My condition is positive for somatostatin receptors.
Exclusion Criteria
Pregnant or breastfeeding women
I am allergic to Lutetium 177Lu or related substances.
I have had Peptide Receptor Radionuclide Therapy.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide or best standard of care
12 weeks
Every 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 2 years
Participant Groups
The COMPOSE study is testing whether a treatment called 177Lu-Edotreotide (a type of PRRT) works better as a first or second option compared to standard therapies like CAPTEM, Everolimus, FOLFOX for certain neuroendocrine tumors. Patients will either receive this new therapy or one of the established treatments.
2Treatment groups
Experimental Treatment
Active Control
Group I: Peptide Receptor Radionuclide Therapy (PRRT) ArmExperimental Treatment2 Interventions
Group II: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)Active Control3 Interventions
177Lu-Edotreotide is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Solucin for:
- Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
🇺🇸 Approved in United States as ITM-11 for:
- Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ICAHN School of Medicine at Mount Sinai, Tish Cancer InstituteNew York, NY
Washington University Alvin J. Siteman Cancer CenterSaint Louis, MO
University of Utah, Huntsman Cancer InstituteSalt Lake City, UT
Oregon Health and Science UniversityPortland, OR
More Trial Locations
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Who Is Running the Clinical Trial?
ITM Solucin GmbHLead Sponsor
References
Symptomatic and Radiological Response to 177Lu-DOTATATE for the Treatment of Functioning Pancreatic Neuroendocrine Tumors. [2020]Peptide receptor radionuclide therapy (PRRT) with the radiolabeled somatostatin analogue [Lutetium-177-DOTA0-Tyr3]octreotate (177Lu-DOTATATE) is widely applied for inoperable metastatic small intestinal and nonfunctioning pancreatic neuroendocrine tumors (pNETs). The aim of this study is to describe the safety and efficacy of the treatment of functioning pNETs.
Safety and Effectiveness of 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy After Regional Hepatic Embolization in Patients With Somatostatin-Expressing Neuroendocrine Tumors. [2022]Peptide receptor radionuclide therapy (PRRT) with Lu-DOTATATE is shown to be an effective therapeutic option for somatostatin-expressing neuroendocrine neoplasms. Some concerns are raised over safety of this modality in patients with a history of regional chemoembolization and radionuclide hepatic embolization (CRHE) and is cause of reluctance among some physicians for suggesting Lu-DOTATATE in this patient population.
Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Peptide receptor radionuclide therapy (PRRT) is one of the most promising therapeutic strategies in neuroendocrine neoplasms (NENs). Nevertheless, its role in certain tumor sites remains unclear. This study sought to elucidate the efficacy and safety of [177Lu]Lu-DOTATATE in NENs with different locations and evaluate the effect of the tumor origin, bearing in mind other prognostic variables. Advanced NENs overexpressing somatostatin receptors (SSTRs) on functional imaging, of any grade or location, treated at 24 centers were enrolled. The protocol consisted of four cycles of 177Lu-DOTATATE 7.4 GBq iv every 8 weeks (NCT04949282).
Peptide Receptor Radionuclide Therapy With 177Lu-Octreotate in Patients With Somatostatin Receptor Expressing Neuroendocrine Tumors: Six Years' Assessment. [2020]Peptide receptor radionuclide therapy (PRRT) with radiolabeled somatostatin analogues is a promising treatment for patients with inoperable, well to moderately differentiated metastatic neuroendocrine tumors (NETs). In continuation of our novel study with the radionuclide lutetium Lu, we now present further results of Lu DOTATATE therapy in managing NETs and other somatostatin receptor-expressing tumors in a larger and more diverse patient group.
ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy. [2023]This practice parameter (PP) for Lutetium-177 (Lu-177) DOTATATE peptide receptor radionuclide therapy (PRRT) aims to guide authorized users in selection of appropriate adult candidates with gastroeneropancreatic neuroendocrine tumors (GEP-NETs) from foregut, midgut, and hindgut. The essential selection criteria include somatostatin receptor-positive GEP-NETs, which are usually inoperable and progressed despite standard therapy. Lu-177 DOTATATE is a radiopharmaceutical with high avidity for somatostatin receptors that are overexpressed by these tumors. This document ensures safe handling of Lu-177 DOTATATE by the authorized users and safe management of affected patients.
Peptide receptor radionuclide therapy with 177Lu-DOTA-octreotate: dosimetry, nephrotoxicity, and the effect of hematological toxicity on survival. [2018]Peptide receptor radionuclide therapy (PRRT) with lutetium-177 (Lu)-DOTATATE is regarded as a safe treatment option with promising results for patients with neuroendocrine neoplasia (NEN). We aimed to study the absorbed organ and tumor doses, the renal and hematological toxicity as well as their mutual interaction. Another aim was the identification of adverse effects as possible predictors which may affect survival.
Lutetium Lu-177 Dotatate Flare Reaction. [2022]Lutetium Lu-177 dotatate is the first peptide receptor radionuclide therapy approved by the US Food and Drug Administration. Well-designed studies in Europe have shown dramatic effectiveness in improving progression-free survival in patients with gastroenteropancreatic neuroendocrine tumors, which are progressive and generally metastatic. This therapy is a molecular targeted therapy linking a beta-emitting radioisotope to dotatate, which binds tightly to somatostatin receptors on neuroendocrine tumors cells. Various adverse effects of this therapy have been reported in the literature, including potential toxicity to renal, hepatic, and hematologic tissues and risk of second malignancy. Our study sought to explore acute adverse effects in this patient population.
90Y/177Lu-DOTATOC: From Preclinical Studies to Application in Humans. [2021]The PRRT (Peptide Receptor Radionuclide Therapy) is a promising modality treatment for patients with inoperable or metastatic neuroendocrine tumors (NETs). Progression-free survival (PFS) and overall survival (OS) of these patients are favorably comparable with standard therapies. The protagonist in this type of therapy is a somatostatin-modified peptide fragment ([Tyr3] octreotide), equipped with a specific chelating system (DOTA) capable of creating a stable bond with β-emitting radionuclides, such as yttrium-90 and lutetium-177. In this review, covering twenty five years of literature, we describe the characteristics and performances of the two most used therapeutic radiopharmaceuticals for the NETs radio-treatment: [90Y]Y-DOTATOC and [177Lu]Lu-DOTATOC taking this opportunity to retrace the most significant results that have determined their success, promoting them from preclinical studies to application in humans.
Evaluation of 177Lu-Dotatate treatment in patients with metastatic neuroendocrine tumors and prognostic factors. [2021]Label="BACKGROUND" NlmCategory="BACKGROUND"> 177Lu peptide receptor radionuclide therapy (PRRT) is a recently approved therapy in Spain that has been demonstrated to be a well-tolerated therapy for positive somatostatin receptor advanced gastroenteropancreatic neuroendocrine tumors.