Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.

• Patients ≥ 18 years of age.

• 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.

• Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index.

• In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging.

• Lesions must have shown radiological evidence of disease progression in the 12 months prior to inclusion in the study. Patients who were receiving systemic anticancer therapy, progression should be documented on therapy or after stopping therapy due to adverse events or other reasons. Patients without prior therapy, documentation of progression is also mandatory to watch and wait strategy or during the follow up after surgery.

• Patients may be included in first-line therapy (systemic treatment naïve) or may have experienced progression on somatostatin analogues or additional systemic treatments, which may include but not limited to chemotherapy, targeted agents or immunotherapy (maximum of 2 prior systemic anti-tumor treatments).

• Note: Somatostatin analogues for patients with functioning tumors are allowed.

• Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1.

• An archival tumor tissue sample should be available for submission to the central laboratory prior to study treatment (36 months). If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided if feasible.

⁃ Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

⁃ Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria:

∙ Neutrophil count (ANC) ≥ 1,500/mm\^3

‣ Platelet count ≥ 75 × 10\^9/L

‣ Hemoglobin ≥ 8 g/dL

‣ Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases

‣ 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.

‣ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases

⁃ Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%) for the duration of the study treatment and for 6 months after the final dose of study treatment.

⁃ Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.

⁃ Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.

⁃ Male patients with a pregnant or breastfeeding partner(s) must agree to abstinence or use a condom for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for at least 6 months after the final study drug administration.

⁃ Subject agrees not to participate in another interventional study while on treatment in the present study.

Locations
Other Locations
Belgium
Antwerp University Hospital (UZA)
RECRUITING
Edegem
France
Centre Hospitalier Universitaire (CHU) Bordeux
RECRUITING
Bourdeaux
Hospital Center University Dijon Bourgogne (CHU Bourgogne)
RECRUITING
Dijon
Lille University Hospital
RECRUITING
Lille
Hôpital Edouard Herriot, Lyon
RECRUITING
Lyon
Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France
RECRUITING
Marseille
Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nantes
RECRUITING
Nantes
I. Gustave Roussy, Paris
RECRUITING
Paris
Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - Irsì - Meldola
RECRUITING
Meldola
Istituto Europeo di Oncologia - Milano
RECRUITING
Milan
Azienda USL IRCCS Di Reggio Emilia
RECRUITING
Reggio Emilia
Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.
NOT_YET_RECRUITING
Roma
Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITING
Verona
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
ICO Institut Català d'Oncologia L'Hospitalet
RECRUITING
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal, Madrid
RECRUITING
Madrid
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Complexo Hospitalario Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
Federico Nepote
investigacion@mfar.net
+34934344412
Time Frame
Start Date: 2023-10-27
Estimated Completion Date: 2028-07
Participants
Target number of participants: 120
Treatments
Experimental: Experimental arm
Treatment with 6 cycles of 7.5 ± 0.7 GBq 177Lu-edotreotide. The prescribed treatment administration is as follows: a 6 (±2) weeks interval between cycles 1 and 2 followed by all remaining cycles (3-6) given 8 (± 1) weeks after the previous cycle), where possible, or until disease progression, intolerable toxicity or death, whichever occurs first.
Active_comparator: Control arm
Everolimus 10 mg orally once daily (QD) until disease progression or intolerable toxicity or death, whichever occurs first.
Sponsors
Leads: Grupo Espanol de Tumores Neuroendocrinos
Collaborators: ITM Oncologics GmbH, MFAR

This content was sourced from clinicaltrials.gov