Alliance A021901 - B-LuRE (Bronchial Neuroendocrine Cancer)

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

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