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Lutathera · 1 trial · 1 indication
The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows. * Radiation fibrosis * Hepatic fibrosis by histologic diagnosis * Hepatic insufficiency * Bowel anastamotic leak (if bowel surgery) * Distal pancreatic leak (if pancreas surgery)
| Arm | Type | Description |
|---|---|---|
| Lutathera | EXPERIMENTAL | 2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT |
| Name | Type | Description |
|---|---|---|
| Lutathera | DRUG | 4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T |
| Gallium 68 Dotatate | DRUG | Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi) |
| Computed Tomography (CT) | PROCEDURE | Medical Imaging |
| Magnetic Resonance Imaging (MRI) | PROCEDURE | Medical Imaging |
| PET/CT | PROCEDURE | Medical Imaging |
Inclusion Criteria: 1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only. 2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford) 3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board disc...
Lutathera is an investigational small molecule being studied for the treatment of Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET). It is currently in Phase 1 clinical development, with an active trial evaluating its use in patients with metastatic, WHO Grade 1 or 2, SSTR positive GEP-NET who are candidates for cytoreductive surgery.
Lutathera is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Gastroenteropancreatic Neuroendocrine Tumor.
Lutathera is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and is designed to evaluate the drug in a small study population of 10 patients.
Lutathera is being studied in a single Phase 1 clinical trial with the identifier NCT04609592. This trial is titled 'Study of PRRT in Metastatic, WHO Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery' and is being conducted in the United States. The study is active but not recruiting, with an enrollment of 10 participants.
Lutathera is being studied as a form of peptide receptor radionuclide therapy (PRRT), as indicated by the clinical trial title. The trial NCT04609592 evaluates PRRT in patients with Gastroenteropancreatic Neuroendocrine Tumor, and Lutathera is the drug being investigated in this context.