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Peptide Receptor Radionuclide Therapy

PRRT for Neuroendocrine Tumors (COMPOSE Trial)

Phase 3
Recruiting
Research Sponsored by ITM Solucin GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) with measurable site of disease per RECIST v1.1 using contrast computed tomography (CT) / magnetic resonance imaging (MRI)
Patients aged ≥ 18 years
Must not have
Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA, any of the comparators, or any excipient or derivative
Prior Peptide Receptor Radionuclide Therapy (PRRT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after disease progression
Awards & highlights

Summary

This trial will compare the effects of a new cancer treatment to the best existing cancer treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to radiation exposure from PRRT such as nausea and fatigue; kidney damage; blood cell count changes leading to increased infection risk; liver toxicity; and allergic reactions to any component of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My GEP-NETs cancer is confirmed and can't be removed by surgery.
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I am 18 years old or older.
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My condition is positive for somatostatin receptors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to Lutetium 177Lu or related substances.
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I have had Peptide Receptor Radionuclide Therapy.
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I have not had major surgery in the last 4 weeks.
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I do not have kidney, liver, heart, or blood conditions that could affect my safety during the trial.
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I have no other cancer types besides the one being treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after disease progression for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival
Secondary outcome measures
Overall Survival

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Neuroendocrine Tumors (NETs) include peptide receptor radionuclide therapy (PRRT) with agents like 177Lu-Edotreotide and 177Lu-Dotatate, and systemic therapies such as everolimus. PRRT targets somatostatin receptors on tumor cells to deliver targeted radiation, effectively killing cancer cells while minimizing damage to healthy tissue. Everolimus is an mTOR inhibitor that interferes with cancer cell growth and proliferation. These mechanisms are important for NET patients as they guide the selection of treatment based on the tumor's receptor status and the patient's overall health, aiming to maximize efficacy and minimize side effects.

Find a Location

Who is running the clinical trial?

ITM Solucin GmbHLead Sponsor
2 Previous Clinical Trials
329 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
309 Patients Enrolled for Neuroendocrine Tumors

Media Library

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04919226 — Phase 3
Neuroendocrine Tumors Research Study Groups: Peptide Receptor Radionuclide Therapy (PRRT) Arm, CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
Neuroendocrine Tumors Clinical Trial 2023: 177Lu-Edotreotide Highlights & Side Effects. Trial Name: NCT04919226 — Phase 3
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919226 — Phase 3
~106 spots leftby Jun 2027