OncoMatch/Clinical Trials/NCT05918302
Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
Is NCT05918302 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including 177Lu-edotreotide and Everolimus for neuroendocrine tumors.
Treatment: 177Lu-edotreotide · Everolimus — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: peptide receptor radionuclide therapy
Prior peptide receptor radionuclide therapy (PRRT)
Cannot have received: mTOR inhibitor (deforolimus, everolimus, sirolimus, temsirolimus)
Prior...mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.)
Cannot have received: hepatic radio-embolization
Exception: within 6 months prior to first dose of study treatment
hepatic radio-embolization (within 6 months prior to first dose of study treatment)
Cannot have received: radiotherapy
Exception: within 12 weeks prior to the first dose of study drug
Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug
Cannot have received: major surgery
Exception: within 12 weeks prior to the first dose of study drug
Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug
Cannot have received: chemotherapy
Exception: not completed 4 weeks prior to the first dose of study drug
chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug
Cannot have received: biologics
Exception: not completed 4 weeks prior to the first dose of study drug
chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug
Cannot have received: immunotherapy
Exception: not completed 4 weeks prior to the first dose of study drug
chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug
Cannot have received: investigational agent
Exception: not completed 4 weeks prior to the first dose of study drug
chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug
Lab requirements
Blood counts
neutrophil count (anc) ≥ 1,500/mm^3; platelet count ≥ 75 × 10^9/l; hemoglobin ≥ 8 g/dl
Kidney function
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.
Liver function
serum bilirubin ≤ 1.5 × uln or ≤ 3 × uln for subjects with gilbert's disease or liver metastases; alt and ast ≤ 2.5 × uln or ≤ 5 x uln for subjects with liver metastases
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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