Health Trials

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

ConditionsAdvanced Lung Neuroendocrine TumorFunctioning Lung Neuroendocrine TumorLocally Advanced Lung Neuroendocrine NeoplasmLung Neuroendocrine NeoplasmLung Neuroendocrine Tumor G1Lung Neuroendocrine Tumor G2Metastatic Lung Neuroendocrine NeoplasmMetastatic Lung Neuroendocrine TumorNon-Functioning Lung Neuroendocrine TumorRecurrent Lung Neuroendocrine NeoplasmUnresectable Lung Neuroendocrine NeoplasmUnresectable Lung Neuroendocrine Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.

Eligibility criteria

Qualifiers

PRE-REGISTRATION: Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e. carcinoid) as assessed by local pathology

Well- or moderately-differentiated neuroendocrine tumor,

Low- or intermediate-grade neuroendocrine tumor, or

Carcinoid tumor (including typical or atypical carcinoid tumors)

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Everolimus
  • Fludeoxyglucose F-18
  • Lutetium Lu 177 Dotatate
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Single Photon Emission Computed Tomography
  • Survey Administration

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

29
Alabama
University of Alabama at Birmingham Cancer Center35233, Birmingham United States
California
Tower Cancer Research Foundation90211, Beverly Hills United States
Loma Linda University Medical Center92354, Loma Linda United States
Cedars-Sinai Medical Center90048, Los Angeles United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov