ClinicalTrials.gov ID:  NCT04665739
Protocol: 23-2009
Investigator: Sukhmani Kaur Padda, MD
Phase: II
Diseases: 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 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.

Watch a short video to learn about this clinical trial and eligibility requirements.

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Pathologic Documentation: Well- or moderately-differentiated neuroendocrine tumor(s) of bronchial/lung 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) Recurrent or locally-advanced/unresectable or metastatic disease (Neuroendocrine tumor of bronchial (i.e. lung) primary site) Radiographic 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 No prior treatment with peptide receptor radionuclide therapy (PRRT) (e.g. lutetium Lu 177 dotatate) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.).

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