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

What this Trial Is About

This research trial investigates the treatment of well to moderately differentiated neuroendocrine tumors of the lung and thymus. It compares two therapies: 177Lu-edotreotide, a type of peptide receptor radionuclide therapy, and everolimus, an oral drug. The study focuses on patients whose tumors have high expression of somatostatin receptors as confirmed by imaging and aims to determine which treatment better delays disease progression. Participants will be randomly assigned in a 3:2 ratio to receive either 177Lu-edotreotide or everolimus. The 177Lu-edotreotide group will receive 6 cycles of treatment spaced between 6 to 8 weeks apart, while the everolimus group will take a daily oral dose of 10 mg until disease progression, intolerable side effects, or death. Treatment will continue unless stopped due to progression, toxicity, or patient choice. Throughout the study, patients will undergo regular tumor assessments using MRI or CT scans every 12 weeks to monitor disease progression. Researchers will measure progression-free survival as the primary outcome over about three years per participant. Other assessments include tumor response rates, overall survival, and quality of life questionnaires. Safety and long-term follow-up will continue even if treatment stops, unless participants withdraw consent entirely.

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