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Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
NCT04665739 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Everolimus
- OTHER Fludeoxyglucose F-18
- DRUG Lutetium Lu 177 Dotatate
Study Locations (20)
California
- Tower Cancer Research Foundation — Beverly Hills
- Loma Linda University Medical Center — Loma Linda
- Cedars Sinai Medical Center — Los Angeles
- UCSF Medical Center-Mission Bay — San Francisco
- Torrance Memorial Physician Network - Cancer Care — Torrance
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation
Illinois
- University of Chicago Comprehensive Cancer Center — Chicago
- UC Comprehensive Cancer Center at Silver Cross — New Lenox
- University of Chicago Medicine-Orland Park — Orland Park
Iowa
- UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny
- Iowa Methodist Medical Center — Des Moines
- UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Massachusetts
- Dana-Farber Cancer Institute — Boston
Minnesota
- Mayo Clinic in Rochester — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-02-03 |
| Est. Completion | 2033-01-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04665739
The ClinicalTrials.gov registry entry for NCT04665739 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Lung Neuroendocrine Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04665739 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04665739 about?
NCT04665739 is a clinical study titled "Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors". 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 dr...
What is the current status of trial NCT04665739?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-02-03. Estimated completion is 2033-01-16.
What conditions does trial NCT04665739 study?
This clinical trial studies the following conditions: Lung Neuroendocrine Neoplasm, Locally Advanced Lung Neuroendocrine Neoplasm, Lung Neuroendocrine Tumor G2, Metastatic Lung Neuroendocrine Neoplasm, Advanced Lung Neuroendocrine Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04665739?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Everolimus (DRUG), Fludeoxyglucose F-18 (OTHER), Lutetium Lu 177 Dotatate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04665739?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04665739 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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