NCT04665739 · National Cancer Institute (NCI)
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood and tissue sample collection
PROCEDURE
Computed Tomography
Undergo CT
DRUG
Everolimus
Given PO
OTHER
Fludeoxyglucose F-18
Given FDG
DRUG
Lutetium Lu 177 Dotatate
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Positron Emission Tomography
Undergo PET
PROCEDURE
Single Photon Emission Computed Tomography
Undergo SPECT
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
Median progression-free survival (PFS)
Time frame: From randomization until either radiographic progression confirmed by central radiology review or death, assessed up to 5 years from study registration
Will be compared between patients with a bronchial neuroendocrine tumor receiving lutetium Lu 177 dotatate to those receiving everolimus. The distribution of PFS will be estimated using the Kaplan Meier method. Will be tested using a one-sided stratified log rank test. The median PFS, along with 90% confidence intervals (CIs), will be estimated for the two treatment groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PRE-REGISTRATION: Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial origin (i.e. carcinoid) as assessed by local pathology
- The pathology report must state ONE of the following:
- Well- or moderately-differentiated neuroendocrine tumor,
- Low- or intermediate-grade neuroendocrine tumor, or
- Carcinoid tumor (including typical or atypical carcinoid tumors)
- PRE-REGISTRATION: Documentation of histology from a primary or metastatic site is allowed
- PRE-REGISTRATION: Functional (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome) or nonfunctional tumors are allowed
- PRE-REGISTRATION: Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible
Where
- Birmingham, Alabama
- Beverly Hills, California
- Loma Linda, California
- Los Angeles, California
- San Francisco, California
- Torrance, California
- Washington D.C., District of Columbia
- Aventura, Florida
- Coral Gables, Florida
- Deerfield Beach, Florida
- Miami, Florida
- Plantation, Florida
And 15 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations