Testing a radioactive drug for advanced bronchial neuroendocrine tumors
Official title: Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors
Run by National Cancer Institute (NCI) · NCT04665739 · Data updated 2026-11-12
This study is testing a new radioactive drug called lutetium Lu 177 dotatate to see if it can help people with advanced bronchial neuroendocrine tumors live longer and feel better compared to the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | National Cancer Institute (NCI) NIH |
| Drugs / interventions | Radiation |
| Locations | 29 sites (Birmingham, Alabama and 28 other locations) |
| Status | Recruiting |
| Started | February 3, 2023 |
| Main results expected | September 1, 2032 |
| Study ends | September 1, 2032 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT04665739 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with well- or moderately-differentiated bronchial neuroendocrine tumors that are somatostatin receptor positive.
✕Probably not a fit
Patients with poorly-differentiated or high-grade neuroendocrine carcinomas are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial evaluates the effectiveness of lutetium Lu 177 dotatate compared to the standard treatment, everolimus, in patients with somatostatin receptor positive advanced bronchial neuroendocrine tumors. The study aims to determine if lutetium Lu 177 dotatate can improve progression-free survival and overall survival rates. Patients will receive the treatment intravenously over several cycles, and their responses will be monitored through imaging and toxicity assessments. The trial also explores the long-term effects of the treatment and its efficacy based on tumor characteristics.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced bronchial neuroendocrine tumors.
How similar studies have gone: Other studies have shown promise with similar radioconjugate approaches, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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
Where it's running
-
Tower Cancer Research Foundation
Beverly Hills, California, United States Recruiting -
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
UCSF Medical Center-Mission Bay
San Francisco, California, United States Recruiting -
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States Recruiting
Show 23 more locations
-
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States Recruiting -
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States Recruiting -
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States Recruiting -
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States Recruiting -
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States Recruiting -
Iowa Methodist Medical Center
Des Moines, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States Recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting -
Missouri Baptist Medical Center
St Louis, Missouri, United States Recruiting -
Case Western Reserve University
Cleveland, Ohio, United States Recruiting -
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting -
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States Recruiting -
Temple University Hospital
Philadelphia, Pennsylvania, United States Recruiting -
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States Recruiting -
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States Recruiting -
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States Withdrawn -
Loma Linda University Medical Center
Loma Linda, California, United States Suspended -
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States Suspended -
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States Suspended -
Duke University Medical Center
Durham, North Carolina, United States Suspended -
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States Suspended
Study contacts
- Principal investigator: Thomas A Hope — Alliance for Clinical Trials in Oncology
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing radiotherapy and everolimus for treating neuroendocrine tumors in the lung and thymus
This study is testing whether a new treatment called 177Lu-edotreotide is better than everolimus for helping people with neuroendocrine tumors in the lung and thymus live longer without their cancer getting worse.
-
Evaluating Cabozantinib and Temozolomide for Lung and GEP Neuroendocrine Tumors
This study is testing if combining two medications, Cabozantinib and Temozolomide, can help people with advanced lung and gastroenteropancreatic neuroendocrine tumors who haven't responded to other treatments.
-
Glofitamab with R-CHOP for Newly Diagnosed HIV-Related Large B-Cell Lymphoma
This phase 1 study tests glofitamab plus R-CHOP chemoimmunotherapy in adults newly diagnosed with HIV-related large B-cell lymphoma to see if the regimen is safe and tolerable.
-
Combo therapy with selumetinib and trastuzumab deruxtecan for advanced pancreatic cancer
This phase 1/2 trial tests whether the combination of selumetinib and DS-8201a (trastuzumab deruxtecan) is safe and whether it can help people with unresectable or metastatic pancreatic ductal adenocarcinoma.
-
Quadruplet induction plus autologous transplant followed by teclistamab maintenance for plasma cell leukemia
This phase 2 trial tests whether adding teclistamab as consolidation after autologous stem cell transplant improves overall survival for patients with plasma cell leukemia compared with the standard D-KRd consolidation.
-
Combining botensilimab and balstilimab after standard treatment for colorectal cancer
This phase 2 trial tests whether giving botensilimab and balstilimab after standard therapy can clear detectable ctDNA in adults with stage II/III colorectal cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.