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

Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Study ID
NCT05918302
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177Lu-edotreotide — DRUG
    6 cycles of 7.5 ± 0.7 Giga becquerel (GBq) 177Lu-edotreotide
  • Everolimus — DRUG
    10 mg orally once daily (QD)

Study Details

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.

Key Dates

First listed
Jun 26, 2023
Start date
Oct 27, 2023
Status verified
Sep 2025
Primary completion
Mar 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Throughout the study period, approximately 3 years per patient ]

Central Contacts

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