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

Overview

About this study

The purpose of the study is to evaluate the effectiveness, safety and 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Patients aged ≥ 18 years.

- Histologically confirmed diagnosis of unresectable, well-differentiated
GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease
per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed
tomography (CT) / magnetic resonance imaging (MRI).

- Somatostatin receptor-positive (SSTR+) disease.

Exclusion Criteria:

- Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic
acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).

- Prior (Peptide Receptor Radionuclide Therapy) PRRT.

- Any major surgery within 4 weeks prior to randomization in the trial.

- Therapy with an investigational compound and/or medical device within 30 days or 7
half-life periods (whichever is longer) prior to randomization.

- Other known malignancies.

- Serious non-malignant disease.

- Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially
interfering with the safety of the trial treatments.

- Pregnant or breastfeeding women.

- Patients not able to declare meaningful informed consent on their own or any other
vulnerable population to that.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Thorvardur Halfdanarson, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office 855-776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thorvardur Halfdanarson, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Clinical Trials