Additional US study sites are now participating in an ongoing clinical trial of peptide receptor radionuclide therapy (PRRT) with 177Lu-edotreotide as a first or second line of treatment in gastroenteric or pancreatic neuroendocrine tumors.
The COMPOSE trial, sponsored by ITM, is comparing the safety, efficacy and patient-reported outcomes of 177Lu-edotreotide to the standard of care for patients who have a well-differentiated and aggressive grade 2 or grade 3, somatostatin receptor-positive (SSTR+) GI NET or PNET.
(Click here for more information on PRRT, including how PRRT works as well as the risks and benefits of the therapeutic approach.)
Study Design
Participants in the COMPOSE clinical trial will be randomized to one of two treatment arms: experimental, targeted therapy with 177Lu-edotreotide or comparator treatment with standard of care (Everolimus, CAPTEM or FOLFOX).
Those randomized to the experimental arm will receive 6 cycles of PRRT treatment with 177Lu-edotreotide. There is a 6-week interval between the first and second treatment cycles and then 8-week intervals between subsequent cycles.
Eligibility Criteria
To be eligible for the COMPOSE trial, participants must:
- Be 18 years of age or older
- Have somatostatin receptor-positive disease
- Have histologically confirmed diagnosis of unresectable, well-differentiated GET-NETs
- Have measurable site of disease RECIST v1.1
- Have not received prior treatment with PRRT
Other criteria will need to be met to confirm eligibility for the trial.
Participating Study Sites
The currently active participating US study sites for the COMPOSE trial are:
- Dana Farber Cancer Institute
- Duke University
- Moffitt Cancer Center
- Mayo Clinic
- Memorial Sloan Kettering Cancer Center
- University of Colorado Hospital
- MD Anderson Cancer Center
- Washington University
Next Steps
Additional information on the COMPOSE study can be found at clinicaltrials.gov. Interested participants should talk to their treatment team about eligibility and determine if the study is aligned with their treatment goals.