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

Recruiting now · Phase 2

Conditions studied: Advanced Lung Neuroendocrine Tumor, Functioning Lung Neuroendocrine Tumor, Locally Advanced Lung Neuroendocrine Neoplasm, 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

In brief

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.

Key facts

Study ID

NCT04665739

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2023-02-03

Expected to finish

2027-07-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• PRE-REGISTRATION: Recurrent or locally-advanced/unresectable or metastatic disease
• PRE-REGISTRATION: Neuroendocrine tumor of bronchial (i.e. lung) primary site
• PRE-REGISTRATION: Lesions must have shown radiological evidence of disease progression in the 12 months prior to pre-registration
• Tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to pre-registration; however, documentation of SSTR positivity in the 6 months prior to pre-registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions
• PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy should not be considered measurable unless the lesion has clearly progressed since the procedure
• PRE-REGISTRATION: Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as >= 1 cm with CT or MRI (or >= 1.5 cm short axis for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung
• REGISTRATION: Confirmation of SSTR positivity by Alliance Imaging Core Lab (ICL) at Imaging and Radiation Oncology Core (IROC) Ohio central radiographic review
• REGISTRATION: Patients with treatment-naive or previously-treated disease are allowed. Patients with previously-treated disease must have demonstrated radiographic disease progression on the prior therapy
• REGISTRATION: No prior treatment with peptide receptor radionuclide therapy (PRRT) (e.g. lutetium Lu 177 dotatate)
• REGISTRATION: No prior treatment with mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.)
• REGISTRATION: Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective radioembolization) or ablative therapies (i.e. cryoablation, radiofrequency ablation, etc.) is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site. Prior liver-directed (including ablative) treatment must be completed at least 28 days prior to registration
• REGISTRATION: Prior treatment with 90-Yttrium radioembolization must be completed at least 6-weeks prior to registration
• REGISTRATION: Radiation therapy to the lung and/or mediastinum must be completed at least 14 days prior to registration for stereotactic ablative and at least 28 days prior to registration for conventional fractionation
• REGISTRATION: Prior treatment with systemic anticancer therapy must be completed at least 28 days prior to registration (except for somatostatin analogs in patients with functional tumors). Continuation of treatment with somatostatin analogs while on protocol therapy is allowed provided that the patient:
• Has functional tumors (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), and
• Has previously demonstrated radiographic disease progression while on somatostatin analog therapy
• REGISTRATION: Patients must have completed any major surgery at least 28 days prior to registration. Complete wound healing from major surgery should occur prior to registration

Where it is running

• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States (enrolling)
• Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
• Case Western Reserve University — Cleveland, Ohio, United States (enrolling)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• UCSF Medical Center-Mission Bay — San Francisco, California, United States (enrolling)
• Torrance Memorial Physician Network - Cancer Care — Torrance, California, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States (enrolling)
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States (enrolling)
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)
• UC Comprehensive Cancer Center at Silver Cross — New Lenox, Illinois, United States (enrolling)
• University of Chicago Medicine-Orland Park — Orland Park, Illinois, United States (enrolling)
• UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States (enrolling)
• Iowa Methodist Medical Center — Des Moines, Iowa, United States (enrolling)
• UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
• Missouri Baptist Medical Center — St Louis, Missouri, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Loma Linda University Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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