RecruitingPhase 2NCT04665739

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors

Sponsor

National Cancer Institute (NCI)

Enrollment

70 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Neuroendocrine Neoplasm Advanced Lung Neuroendocrine Tumor Functioning Lung Neuroendocrine Tumor Locally Advanced Lung Neuroendocrine Neoplasm Lung Neuroendocrine Tumor G1 Lung Neuroendocrine Tumor G2 Metastatic Lung Neuroendocrine Neoplasm Metastatic Lung Neuroendocrine Tumor Non-Functioning Lung Neuroendocrine Tumor Recurrent Lung Neuroendocrine Neoplasm Unresectable Lung Neuroendocrine Neoplasm Unresectable Lung Neuroendocrine Tumor

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive treatment called Lutetium-177 DOTATATE (also known as Lutathera) in patients with a rare type of slow-growing lung tumor called a bronchial neuroendocrine tumor (carcinoid tumor). This drug targets tumors that have special receptors on their surface and delivers radiation directly to the cancer cells. **You may be eligible if you:** - Have a confirmed diagnosis of a well- or moderately-differentiated neuroendocrine (carcinoid) tumor of bronchial (lung) origin - Have tumors that show up on a somatostatin receptor scan (meaning the tumor has the specific receptors this treatment targets) - Have advanced disease that has progressed despite other treatments **You may NOT be eligible if you:** - Have a poorly differentiated or high-grade neuroendocrine tumor - Have certain conditions that would make the treatment unsafe, including poorly functioning kidneys, liver, or bone marrow Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and tissue sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGEverolimus

Given PO

OTHERFludeoxyglucose F-18

Given FDG

DRUGLutetium Lu 177 Dotatate

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT

OTHERSurvey Administration

Ancillary studies

Locations(29)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT04665739

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