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The phase 3 COMPOSE trial will look at the efficacy of using 177lu-edotreotide — a novel radiopharmaceutical that is designed to limit radiation exposure to normal tissue — in patients with later stage neuroendocrine tumors.
ITM Isotope Technologies Munich SE recently announced the launch of a phase 3 trial that is expected to analyze the viability of using a novel radiopharmaceutical to treat patients with certain neuroendocrine tumors.
The plan with this trial — referred to as the COMPOSE trial— is to study a particular treatment in patients with well-differentiated aggressive grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The treatment, n.c.a. 177lu-edotreotide, is a targeted radionuclide therapy that contains lutetium-177 — a radioactive isotope — fused with a somatostatin analogue (which stops the body from making too many hormones) to target GEP-NETs. Targeted radionuclide therapy is a newer type of cancer therapy that delivers radiation directly to the tumor while avoiding regular tissue.
“The most common form of NETs is gastroenteropancreatic and often develops metastatic disease, limiting treatment options. N.c.a. 177Lu-edotreotide has previously shown a favorable safety and efficacy profile in GEP-NETs and with COMPOSE we aim to also make it available to late-stage patients suffering from this hard-to-treat cancer indication,” stated Steffen Schuster, CEO of ITM, in a news release.
The intent of the randomized trial is to examine the efficacy, safety and patient-reported outcomes of the novel drug compared with certain active chemotherapies in 202 patients across multiple treatment centers. The study authors will look at the treatment’s effect on progression-free survival (time during and after treatment a patient is alive, but the disease did not get worse) every 12 weeks, and the study is expected to be completed by September 2026.
Patients may be included in the trial if they have a histologically confirmed diagnosis of unresectable, well-differentiated GEP-NETs, measurable site of disease per RECIST v1.1 (response evaluation criteria in solid tumors) using contrast CT/MRI, are aged 18 years or older and have somatostatin receptor-positive (SSTR+) disease.
Potential reasons a patient may not be inserted into the trial include having a known hypersensitivity to Lutetium 177Lu-edotreotide, DOTA (dodecane tetraacetic acid), any of the chemotherapy comparators, or any excipient or derivative (e.g. rapamycin); prior receipt of peptide receptor radionuclide therapy, any major surgery within four weeks before trial participation; therapy with an investigational drug and/or medical device within 30 days or seven half-life periods before trial participation; having other known malignancies or serious non-malignant disease; having renal, hepatic, cardiovascular or hematological organ dysfunction and being pregnant or breastfeeding.
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