NL-OMON56413招募中3 期
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) - 177Lu-Edotreotide vs Best Standard of Care in Grade 2 and Grade 3 GEP-NETs
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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
- •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.
研究者
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