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 (Jun 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
Treatments studied
Targeted therapy
Radioligand therapy
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.
Frequently asked questions
Is NCT05918302 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior peptide receptor radionuclide therapy, mTOR inhibitor, hepatic radio-embolization disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages