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.
Who Can Participate?
Eligibility
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)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
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
Michael
Morse
Protocol Number
PRO00117933
NCT ID
NCT04665739
Phase
II
Enrollment Status
Pending Open to Enrollment