A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient- reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin receptor-positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)

Phase 3

Recruiting

• Conditions: gastroenteropancreatic neuroendocrine tumors; 10014713

• Registration Number: NL-OMON56413
• Lead Sponsor: ITM Solucin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Provided written informed consent.
2. Patients aged >= 18 years (fully mature per local regulations).
3. Histologically confirmed diagnosis of unresectable or metastatic,
well-differentiated GEP-NETs, with a Ki-67 index between 15 and 55, inclusive.
4. In the Investigator*s opinion, eligible to receive treatment with at least
one of the following: CAPTEM, everolimus or FOLFOX.
5. At least 1 measurable site of disease per RECIST v1.1 using contrast
computed tomography (CT)/magnetic resonance imaging (MRI).
6. SSTR+ disease.
7. All patients need to undergo an FDG PET scan within 2 months prior to
randomization and as close as possible to the PET SRI.
8. Patients may be treatment naive (first-line received in COMPOSE trial) or
have a maximum of one prior line of systemic therapy, including SSAs
(second-line received in COMPOSE trial).
9. Karnofsky-score >= 60.

Exclusion Criteria

1. Known hypersensitivity to 177Lu, edotreotide, DOTA, any of the comparators,
or any excipient or derivative (e.g. rapamycin).
2. Known hypersensitivity to lysine, arginine, or any excipient of the
nephroprotective AAS given concurrently with the lutetium (177Lu) edotreotide
infusion.
3. Prior external beam radiation therapy (EBRT) to GEP-NET lesions or liver
directed selective internal radiation therapy within 12 weeks before
randomization.
4. Prior selective internal radiation therapy.
5. Prior PRRT.
6. Received chemotherapy, mammalian target of rapamycin (mTOR) inhibitors,
vascular endothelial growth factor (VEGF) pathway inhibitors, immunotherapy,
interferon, chemo-embolization, bland embolization, cyclosporine A,
locoregional treatment (e.g. cytoreduction surgery, radiofrequency ablation
[RFA], liver directed intra-arterial intervention) or SSAs within 4 weeks prior
to randomization into the trial.
7. Any major surgery within 4 weeks prior to randomization in the trial.
8. Therapy with an investigational compound and/or medical device within 30
days or 7 half-life periods (whichever is longer) prior to randomization. Live
attenuated vaccines should not be administered during the trial treatment and
over the next 3 months after the last treatment dose.
9. Patients with known brain metastases, unless these metastases have been
treated and stabilized for at least 24 weeks prior to randomization. Patients
with brain metastases must have a head CT or MRI with contrast to document
stable brain disease.
10. Other known malignancies, (except non-invasive skin cancer, superficial
bladder cancer and carcinoma of the cervix in situ), unless definitively
treated and proven no evidence of recurrence for 3 years.
11. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune,
metabolic or dementia), that may interfere with the objectives of the trial or
with the safety or compliance of the patient, as judged by the Investigator.
12. Renal, hepatic, cardiovascular, or hematological organ dysfunction,
potentially interfering with the safety of the trial treatments.
13. Current spontaneous urinary incontinence preventing safe administration of
the IMP, in the investigator's opinion.
14. Pregnancy and breast-feeding
15. Patients not able to declare meaningful informed consent on their own or
any other vulnerable population to that sense.

Study & Design

• Study Type: Interventional
• Study Design: Not specified