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ACTIVE NOT RECRUITING Phase 3

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

NCT04919226 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

Conditions Studied

Interventions

  • DRUG Everolimus
  • DRUG 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
  • DRUG CAPTEM (Capecitabine and Temozolomide)
  • OTHER Amino-Acid Solution
  • DRUG FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Study Locations (20)

New York

  • Memorial Sloan-Kettering Cancer Center — New York
  • ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute — New York

Texas

  • Texas Oncology — Dallas
  • University of Texas MD Anderson Cancer Center — Houston

Other

  • Fudan University Shanghai Cancer Center — Shanghai
  • Affiliated Hospital of Jiangnan University — Wuxi

California

  • Stanford Cancer Center — Palo Alto

Colorado

  • University of Colorado Hospital, Nuclear Medicine — Aurora

Florida

  • H. Lee Moffitt Cancer Center & Research Institute — Tampa

Massachusetts

  • Dana Farber Cancer Institute — Boston

Minnesota

  • Mayo Clinic - Rochester, Department of Oncology — Rochester

Trial Details

FieldValue
Enrollment Target 259 participants
Start Date 2021-12-21
Est. Completion 2027-09
Phase Phase 3

Sponsor

ITM Solucin

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04919226

The ClinicalTrials.gov registry entry for NCT04919226 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ITM Solucin, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 5 interventions — of which Everolimus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04919226 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04919226 about?

NCT04919226 is a clinical study titled "Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE". The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, soma...

What is the current status of trial NCT04919226?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 259 participants. The study started on 2021-12-21. Estimated completion is 2027-09.

What conditions does trial NCT04919226 study?

This clinical trial studies the following conditions: Neuroendocrine Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04919226?

The interventions under investigation include: Everolimus (DRUG), 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT (DRUG), CAPTEM (Capecitabine and Temozolomide) (DRUG), Amino-Acid Solution (OTHER), FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04919226?

This trial is sponsored by ITM Solucin, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04919226 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial