XCancer

Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

Description:

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

Government Study Link:

NCT05918302 - Click here to see study on

ClinicalTrials.gov

edotreotide

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA
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.