What side effects are associated with this type of intervention?

The most common treatments for Neuroendocrine Tumors (NETs) that target somatostatin receptors, such as 177Lu-Edotreotide and 177Lu-Dotatate, are generally well-tolerated but can have notable side effects. These include nausea, vomiting, fatigue, and mild to moderate hematologic toxicities like anemia and thrombocytopenia. Serious adverse events are rare but can include myelodysplastic syndrome and, in very rare cases, acute myelogenous leukemia. Everolimus, another systemic therapy option, can cause side effects such as stomatitis, rash, diarrhea, fatigue, and infections. Both treatments require careful monitoring to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved 177Lu-Dotatate for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. This approval was largely based on data from the NETTER-1 trial, which demonstrated the efficacy and safety of 177Lu-Dotatate. The recommended dose is 7.4 GBq (200 millicuries) administered as an intravenous infusion over 30 minutes every eight weeks for a total of four doses. This treatment, like 177Lu-Edotreotide, targets somatostatin receptors on tumor cells to deliver targeted radiation.

What other types of research exist?

Promising novel alternatives to 177Lu-Edotreotide for NETs include: 1) Radiolabeled octreotide, such as 90Y-DOTA-TOC, which has shown efficacy in reducing tumor markers and extending survival in patients with metastatic medullary thyroid carcinoma. 2) Everolimus, an mTOR inhibitor, which has demonstrated significant progression-free survival benefits in advanced NETs. 3) Peptide receptor radionuclide therapy (PRRT) with 177Lu-Dotatate, which has shown high progression-free survival rates and improved quality of life in patients with midgut NETs. These alternatives offer targeted approaches with varying mechanisms of action and have shown promising results in clinical trials.

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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

Pivotal Trial

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after disease progression

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival

Secondary study objectives

Overall Survival

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met

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.