Alliance A021901 - B-LuRE (Bronchial Neuroendocrine Cancer)

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called Lutetium Lu 177 dotatate (the study drug) has the potential to shrink or stabilize bronchial neuroendocrine tumors. We will compare how the study drug works to everolimus, which is the usual drug used for this diagnosis.

What is the Condition Being Studied?

Advanced Bronchial Neuroendocrine Cancer

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with a bronchial neuroendocrine tumor
  • Have never been treated with peptide receptor radionuclide therapy (PRRT)
  • Have never been treated with mammalian target of rapamycin (mTOR) inhibitors (for example: deforolimus, everolimus, sirolimus, or temsirolimus)

For more information, contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

  • Group1: If you are in this group, you will get the study drug through a vein in the arm every 8 weeks. You will get up to 4 doses of the study drug.
  • Group2: If you are in this group, you will get the usual drug, everolimus, as a tablet you take by mouth every day.

Study Details

Full Title
A021901: Randomized Phase II Trial of Lutetium Lu 177 Dotatate versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00117933
NCT: NCT04665739
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF