Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
NCT ID: NCT05918302
Last Updated: 2025-12-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-27
Study Completion Date
2028-07-31
Brief Summary
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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.
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Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
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Detailed Description
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The LEVEL Trial is a randomized, prospective, international, open-label, phase III study comparing everolimus and 177Lu-edotreotide in advanced somatostatin receptor positive (SSTR+) lung and thymic well differentiated neuroendocrine tumors with high expression of somatostatin receptors confirmed by positron emission tomography somatostatin receptor imaging.
In the investigator's opinion, patients recruited into the trial must be eligible to receive everolimus. Patients with both functional and nonfunctional lung and thymus neuroendocrine tumors (NETs) will be included in this trial. In total, 120 patients will be randomized in a 3:2 proportion to either experimental or control arms, respectively.
Randomization will be stratified according to prior medical therapy (tumor treatment-naïve \[patients who have not received any prior systemic anticancer therapy\] versus non-treatment- naïve \[patients who have received one or two prior line of systemic anticancer therapy, including somatostatin analogs (SSAs) as anti-tumor treatment\]) and histological differentiation (typical versus atypical / well versus moderately differentiated). Stratification according to the functional status is not foreseen considering the poor predictive and prognostic relevance of this criteria on PRRT in the literature.
Diagnosis of progression and tumor burden will be established based on radiological information from morphological imaging (magnetic resonance imaging \[MRI\] and/or computed tomography \[CT\]) according to RECIST v1.1. Tumors assessments will be scheduled every 12 ± 2 weeks from randomization (the first scan will be performed after Cycle 2 for the 177Lu-edotreotide until radiologically confirmed progression of the disease, initiation of new subsequent anticancer therapy, or death (whichever comes first). The scanning modality and protocol should be consistent with the baseline scan. Diagnosis of RECIST v1.1 progression will be made by the local investigator. The confirmatory scans should be performed preferably at the next scheduled imaging visit and no less than 4 weeks after the prior assessment of progression (PD) (in the absence of clinically significant deterioration). Additional MRI/CT scans may be performed at any other time if, in the investigator's clinical judgment, PD is suspected. For equivocal findings of progression, treatment may continue until the next scheduled assessment.
In both arms, for a given patient, trial treatment dosing should be discontinued if there is evidence of RECIST v1.1 progression, in case of persistent toxicities or if the patient withdraws consent to continue with treatment. In all cases, if possible, all other protocol scheduled assessments should be continued until the end of the long-term follow-up period, unless the patient explicitly withdraws consent to all trial procedures and follow-up.
In the investigator's opinion, patients recruited into the trial must be eligible to receive everolimus. Patients with both functional and nonfunctional lung and thymus neuroendocrine tumors (NETs) will be included in this trial. In total, 120 patients will be randomized in a 3:2 proportion to either experimental or control arms, respectively.
Randomization will be stratified according to prior medical therapy (tumor treatment-naïve \[patients who have not received any prior systemic anticancer therapy\] versus non-treatment- naïve \[patients who have received one or two prior line of systemic anticancer therapy, including somatostatin analogs (SSAs) as anti-tumor treatment\]) and histological differentiation (typical versus atypical / well versus moderately differentiated). Stratification according to the functional status is not foreseen considering the poor predictive and prognostic relevance of this criteria on PRRT in the literature.
Diagnosis of progression and tumor burden will be established based on radiological information from morphological imaging (magnetic resonance imaging \[MRI\] and/or computed tomography \[CT\]) according to RECIST v1.1. Tumors assessments will be scheduled every 12 ± 2 weeks from randomization (the first scan will be performed after Cycle 2 for the 177Lu-edotreotide until radiologically confirmed progression of the disease, initiation of new subsequent anticancer therapy, or death (whichever comes first). The scanning modality and protocol should be consistent with the baseline scan. Diagnosis of RECIST v1.1 progression will be made by the local investigator. The confirmatory scans should be performed preferably at the next scheduled imaging visit and no less than 4 weeks after the prior assessment of progression (PD) (in the absence of clinically significant deterioration). Additional MRI/CT scans may be performed at any other time if, in the investigator's clinical judgment, PD is suspected. For equivocal findings of progression, treatment may continue until the next scheduled assessment.
In both arms, for a given patient, trial treatment dosing should be discontinued if there is evidence of RECIST v1.1 progression, in case of persistent toxicities or if the patient withdraws consent to continue with treatment. In all cases, if possible, all other protocol scheduled assessments should be continued until the end of the long-term follow-up period, unless the patient explicitly withdraws consent to all trial procedures and follow-up.
Conditions
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Neuroendocrine Tumors
Lung Neuroendocrine Neoplasm
Thymus Neoplasms
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
177Lu-edotreotide
Intervention Type
DRUG
6 cycles of 7.5 ± 0.7 Giga becquerel (GBq) 177Lu-edotreotide
Control arm
Everolimus 10 mg orally once daily (QD) until disease progression or intolerable toxicity or death, whichever occurs first.
Group Type
ACTIVE_COMPARATOR
Everolimus
Intervention Type
DRUG
10 mg orally once daily (QD)
Interventions
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177Lu-edotreotide
6 cycles of 7.5 ± 0.7 Giga becquerel (GBq) 177Lu-edotreotide
Intervention Type
DRUG
Everolimus
10 mg orally once daily (QD)
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
2. Patients ≥ 18 years of age.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1.
9. 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.
10. Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
11. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria:
1. Neutrophil count (ANC) ≥ 1,500/mm\^3
2. Platelet count ≥ 75 × 10\^9/L
3. Hemoglobin ≥ 8 g/dL
4. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases
5. 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.
6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases
12. 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.
13. 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.
14. 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.
15. 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.
16. Subject agrees not to participate in another interventional study while on treatment in the present study.
2. Patients ≥ 18 years of age.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1.
9. 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.
10. Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
11. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria:
1. Neutrophil count (ANC) ≥ 1,500/mm\^3
2. Platelet count ≥ 75 × 10\^9/L
3. Hemoglobin ≥ 8 g/dL
4. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases
5. 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.
6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases
12. 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.
13. 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.
14. 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.
15. 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.
16. Subject agrees not to participate in another interventional study while on treatment in the present study.
Exclusion Criteria
1. Patients who are not able to swallow tablets.
2. 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.
3. Patients with brain mets unless stable on treatment for \> 12 weeks and with no evidence of raised intracranial pressure or mass effect.
4. Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
5. Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
6. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA \[qualitative\] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).
7. Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment.
Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose.
8. Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.
9. 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).
10. Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug.
11. 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.
12. Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus.
13. Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS).
14. Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion.
15. Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.
2. 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.
3. Patients with brain mets unless stable on treatment for \> 12 weeks and with no evidence of raised intracranial pressure or mass effect.
4. Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
5. Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
6. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA \[qualitative\] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).
7. Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment.
Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose.
8. Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.
9. 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).
10. Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug.
11. 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.
12. Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus.
13. Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS).
14. Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion.
15. Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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ITM Oncologics GmbH
INDUSTRY
Sponsor Role
collaborator
MFAR
OTHER
Sponsor Role
collaborator
Grupo Espanol de Tumores Neuroendocrinos
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jaume Capdevila, M.D. Ph.D.
Role: STUDY_CHAIR
Hospital Vall d'Hebron
Locations
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Antwerp University Hospital (UZA)
Edegem, Edegem, Belgium
Site Status
RECRUITING
CHU Liège
Liège, , Belgium
Site Status
RECRUITING
Hospital Center University Dijon Bourgogne (CHU Bourgogne)
Dijon, Dijon, France
Site Status
RECRUITING
Centre Hospitalier Universitaire (CHU) Bordeux
Bourdeaux, , France
Site Status
RECRUITING
Lille University Hospital
Lille, , France
Site Status
RECRUITING
Hôpital Edouard Herriot, Lyon
Lyon, , France
Site Status
RECRUITING
Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France
Marseille, , France
Site Status
RECRUITING
Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier
Montpellier, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Site Status
RECRUITING
I. Gustave Roussy, Paris
Paris, , France
Site Status
RECRUITING
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, Reggio Emilia, Italy
Site Status
RECRUITING
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola
Meldola, , Italy
Site Status
RECRUITING
Istituto Europeo di Oncologia - Milano
Milan, , Italy
Site Status
RECRUITING
Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.
Roma, , Italy
Site Status
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Site Status
RECRUITING
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain
Site Status
RECRUITING
ICO Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Site Status
RECRUITING
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain
Site Status
RECRUITING
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Site Status
RECRUITING
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Madrid, Spain
Site Status
RECRUITING
Fundación Jiménez Díaz University Hospital
Madrid, Madrid, Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Site Status
RECRUITING
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Site Status
RECRUITING
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Site Status
RECRUITING
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Site Status
RECRUITING
Countries
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Belgium
France
Italy
Spain
Central Contacts
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Facility Contacts
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References
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Capdevila J, Pubul V, Anido U, Walter T, Molina-Cerrillo J, Alonso-Gordoa T, Garcia-Carbonero R, San-Roman-Gil M, Llana B, Jimenez-Fonseca P, Benavent Vinuales M, Ansquer C, Baudin E, Lepage C, Del Olmo-Garcia M, Ruffinelli JC, Beron A, Haissaguerre M, Deshayes E, Taieb D, Baldari S, Sansovini M, Cingarlini S, Filice A, Panzuto F, Alvarez-Alvarez R, Lousberg L, Aboubakar Nana F, Hernando J, Garcia-Alvarez A, Garcia-Burillo A, Villacampa G, Vandamme T, Fazio N, Durand A. A Randomized clinical trial evaluating the impact on survival and quality of life of 177Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217). BMC Cancer. 2025 Apr 4;25(1):613. doi: 10.1186/s12885-025-13941-3.
Reference Type
DERIVED
Other Identifiers
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2022-502154-13-00
Identifier Type: OTHER
Identifier Source: secondary_id
GETNE-T2217
Identifier Type: -
Identifier Source: org_study_id
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