Testing Lutetium Lu 177 Dotatate for Advanced Bronchial Neuroendocrine Tumors
This study is comparing a new treatment, Lutetium Lu 177 dotatate, to a standard treatment, everolimus, for patients with advanced bronchial neuroendocrine tumors that have spread. Lutetium Lu 177 dotatate is a radioactive drug that targets and may kill tumor cells that have a specific protein called a somatostatin receptor. The goal is to see if Lutetium Lu 177 dotatate can stop the cancer from growing for longer than everolimus. You may be able to join if you have well- or moderately-differentiated neuroendocrine tumors of bronchial origin. The study is currently enrolling about 70 participants, but its status is unclear.
- Study design
- This is an interventional study that plans to enroll 70 participants. Patients will be randomly assigned to receive either Lutetium Lu 177 dotatate or everolimus.
- What's involved
- You would undergo blood and tissue sample collection, CT scans, and potentially FDG scans. Treatment involves receiving Lutetium Lu 177 dotatate intravenously or taking everolimus by mouth.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be measured from randomization until either radiographic progression or death, assessed for up to 5 years from study registration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04665739
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~70 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyEverolimusFludeoxyglucose F-18Lutetium Lu 177 DotatateMagnetic Resonance Imaging
At a glance
Recruiting sites
23 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Median progression-free survival (PFS)
Measured over From randomization until either radiographic progression confirmed by central radiology review or death, assessed up to 5 years from study registration
Conditions
Where it's being run
29 sites across 14 statesCalifornia5
Florida5
Illinois3
Iowa3
Pennsylvania3
Ohio2
Alabama1
District of Columbia1
Study leadership
- Thomas A Hope · PRINCIPAL_INVESTIGATOR · Alliance for Clinical Trials in Oncology
Who to contact
Site Public Contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
REGISTRATION: Patients should have improvement of any toxic effects of prior therapy (except alopecia, fatigue, and other non-reversible toxic effects such as neuropathy from cisplatin) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1 or less
REGISTRATION: Not pregnant and not nursing
Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 28 days prior to registration is required
REGISTRATION: Age \>= 18 years
REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
REGISTRATION: Hemoglobin \>= 8.0 g/dL
REGISTRATION: Platelet count \>= 75,000/mm\^3
REGISTRATION: Absolute neutrophil count (ANC) \>= 1,500/mm\^3
REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance \>= 40 mL/min
Calculated by the Cockcroft-Gault equation
REGISTRATION: Total bilirubin =\< 2.0 x ULN
In patients with Gilbert's syndrome, if total bilirubin is \> 2.0 x ULN, then direct bilirubin must be =\< 2.0 x ULN
REGISTRATION: Albumin \>= 2.8 g/dL
REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN
REGISTRATION: No known central nervous system metastases unless treated and clinically stable for at least 14 days prior to registration. Patients on steroid support must be clinically stable on weaning doses of steroids
REGISTRATION: No other currently active malignancy that requires therapy or is expected to require therapy during the study (excluding non-melanoma skin cancers or in situ carcinomas, such as breast or cervical)
REGISTRATION: No known active hepatitis B (defined as hepatitis B surface antigen \[HbsAg\] reactive) or known active hepatitis C virus (defined as hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] viral load detected). The exception is for patients with known active hepatitis B virus (defined as HbsAg reactive) infection, where the HBV viral load must be undetectable on suppressive therapy for patient to be eligible
REGISTRATION: Patients with known human immunodeficiency virus (HIV) infections on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
REGISTRATION: No known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to registration
REGISTRATION: No receipt of live attenuated vaccines in the 7 days prior to registration
REGISTRATION: No known decompensated liver cirrhosis
REGISTRATION: No known prior drug-induced pneumonitis that was symptomatic or required treatment
REGISTRATION: No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent
REGISTRATION: No known hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus, etc.)
REGISTRATION: Concurrent somatostatin analog use while on protocol therapy is allowed provided that the patient: 1) has a functional tumor (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), 2) has previously demonstrated radiographic disease progression while on somatostatin analog therapy
REGISTRATION: Chronic concomitant treatment with P-gp and strong CYP3A4 inhibitors and/or inducers is not allowed on the everolimus treatment arm of this study. Given that the study is randomized, all patients on P-gp and strong CYP3A4 inhibitors and/or inducers must discontinue the drug(s) 7 days prior to registration
RE-REGISTRATION: Confirmation of disease progression by RECIST v1.1 by real-time Alliance ICL at IROC Ohio central radiographic review
RE-REGISTRATION: Not pregnant and not nursing
Women of childbearing potential only, a negative pregnancy test done =\< 28 days prior to re-registration is required
RE-REGISTRATION: ECOG performance status 0-2
RE-REGISTRATION: Hemoglobin \>= 8.0 g/dL
RE-REGISTRATION: Platelet count \>= 75,000/mm\^3
RE-REGISTRATION: Absolute neutrophil count (ANC) \>= 1,500/mm\^3
RE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance \>= 40 mL/min
Calculated by the Cockcroft-Gault equation
RE-REGISTRATION: Total bilirubin =\< 2.0 x ULN
In patients with Gilbert's syndrome, if total bilirubin is \> 2.0 x ULN, then direct bilirubin must be =\< 2.0 x ULN
RE-REGISTRATION: Albumin \>= 2.8 g/dL
RE-REGISTRATION: AST/ALT =\< 3.0 x ULN
What this trial measures
- Median progression-free survival (PFS)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.