Find a Trial Find Expert Physicians 
News Trial Stats
Clinical TrialsFacts & Fears Who pays for it, placebos, being a guinea pig, and what taking part really means.Basics ofTheranostics A fundamental way of finding and treating your cancer, all in one.Basics ofRadiation What is radiation, and how can it benefit you? InterpretingYour Scans What CT, MRI and PET can and can’t tell you about cancer.What to Expect as aTheranostic Patient Scans, treatment day, and the precautions once you are home.Basics ofDosimetry How much radiation each organ and tumor actually absorbs.TheranosticDictionary Plain-language meanings for the vocabulary on your paperwork.
News Trial Stats
Contact XCancer®
Mon–Thu 8am–4:30pm CT · Fri 8am–3pm CT
Clinical Trial · NCT05918302
Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
Overview
LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.
Sponsor
Unknown Organization
Phase
Phase 3
Contacts
Jaume Capdevila, M.D. Ph.D. (STUDY_CHAIR)
Federico Nepote (CONTACT)
investigacion@mfar.net
+34934344412
ClinicalTrials.gov
NCT05918302Drug / Compound
edotreotide
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- SSTR2
Ligand Class: Peptides
Chelator: DOTA
Eligibility
Inclusion
- Platelet count ≥ 75 × 10\^9/L
- Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria:
- Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases
- Neutrophil count (ANC) ≥ 1,500/mm\^3
- Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed.
- Hemoglobin ≥ 8 g/dL
- Patients who have histologically confirmed metastatic or locally advanced unresectable well/moderately differentiated; World Health Organization (WHO\]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning.
Exclusion
- Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible.
- Patients who have had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug.
- Prior peptide receptor radionuclide therapy (PRRT) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.); or hepatic radio-embolization (within 6 months prior to first dose of study treatment).
- Patients with brain mets unless stable on treatment for \> 12 weeks and with no evidence of raised intracranial pressure or mass effect.
- Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug.
Share your feedback
Help us improve your experience