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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: MRI scans, CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on the trial as well as fludeoxyglucose F-18 (FDG) PET and single photon emission computed tomography (SPECT) on the trial."
- "Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial."
- "After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years following study registration."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares lutetium Lu 177 dotatate, a radioactive drug, with the usual drug, everolimus. It is for adults with advanced lung neuroendocrine tumors, also called carcinoid tumors, that have a protein called a somatostatin receptor. The study tests whether the radioactive drug is better at shrinking tumors or stopping their growth.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and able to care for yourself and be up for at least half of your waking hours.
- Have a lung carcinoid tumor confirmed by a tissue test. The tumor must be low or intermediate grade, not high grade.
- Have cancer that has come back, cannot be removed by surgery, or has spread. Scans must show it grew within the past 12 months.
- Have tumors that can be measured on CT or MRI scans. A special PET scan within the past 12 months must show the required protein in all measurable tumors, with study review confirming this.
- You may have had treatment before or no treatment. If treated before, scans must show the cancer grew while on that treatment.
- Finish earlier cancer treatments and major surgery within the required waiting periods. Surgical wounds must heal, and most treatment side effects must be mild.
- Meet the study's blood count, kidney, and liver test requirements.
- If you can become pregnant, have a negative pregnancy test within 28 days before joining.
Who can't join
- Have a high-grade lung neuroendocrine cancer, small cell lung cancer, or a mixed tumor type.
- Have had tumor-targeted radiation drug treatment, such as lutetium Lu 177 dotatate, or drugs called mTOR inhibitors, such as everolimus.
- Be pregnant or breastfeeding.
- Have cancer in the brain or spinal cord unless treated and stable for at least 14 days. Another active cancer needing treatment may also exclude you, with some skin and early-stage cancer exceptions.
- Have active hepatitis C or active hepatitis B that is not controlled with treatment. People with HIV must be on effective treatment with no detectable virus within the past 6 months.
- Have an active or uncontrolled infection needing antibiotics or antifungal drugs in the 3 days before joining, or have received a live vaccine in the past 7 days.
- Have severe liver scarring with loss of liver function, or past drug-caused lung swelling that caused symptoms or needed treatment.
- Have trouble swallowing or absorbing medicine, or a known allergy to everolimus or similar drugs.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (29)
AL
- University of Alabama at Birmingham Cancer Center · Birmingham, AL 35233More trials in Birmingham
CA
- Tower Cancer Research Foundation · Beverly Hills, CA 90211Site Public Contact · Study contact · towercancerresearch@toweroncology.comAndrew E. Hendifar · Principal investigatorMore trials in Beverly Hills
- Loma Linda University Medical Center · Loma Linda, CA 92354More trials in Loma Linda
- Cedars-Sinai Medical Center · Los Angeles, CA 90048Site Public Contact · Study contact · 310-423-2133 · Cancer.trial.info@cshs.orgAndrew E. Hendifar · Principal investigatorMore trials in Los Angeles
- UCSF Medical Center-Mission Bay · San Francisco, CA 94158Site Public Contact · Study contact · 877-827-3222 · cancertrials@ucsf.eduClaire Mulvey · Principal investigatorMore trials in San Francisco
- Torrance Memorial Physician Network - Cancer Care · Torrance, CA 90505Site Public Contact · Study contact · 310-750-3300 · courtney.steeneken@tmphysicians.comAndrew E. Hendifar · Principal investigatorMore trials in Torrance
DC
- MedStar Georgetown University Hospital · Washington D.C., DC 20007More trials in Washington D.C.
FL
- UM Sylvester Comprehensive Cancer Center at Aventura · Aventura, FL 33180More trials in Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, FL 33146Site Public Contact · Study contact · 305-243-2647Lawrence M. Negret · Principal investigatorMore trials in Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL 33442Site Public Contact · Study contact · 305-243-2647Lawrence M. Negret · Principal investigatorMore trials in Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL 33136Site Public Contact · Study contact · 305-243-2647Lawrence M. Negret · Principal investigatorMore trials in Miami
- UM Sylvester Comprehensive Cancer Center at Plantation · Plantation, FL 33324Site Public Contact · Study contact · 305-243-2647Lawrence M. Negret · Principal investigatorMore trials in Plantation
IA
- UI Health Care Mission Cancer and Blood - Ankeny Clinic · Ankeny, IA 50023Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Ankeny
- Iowa Methodist Medical Center · Des Moines, IA 50309Site Public Contact · Study contact · 515-241-6727Seema Harichand-Herdt · Principal investigatorMore trials in Des Moines
- UI Health Care Mission Cancer and Blood - Des Moines Clinic · Des Moines, IA 50309Site Public Contact · Study contact · 515-241-3305Seema Harichand-Herdt · Principal investigatorMore trials in Des Moines
IL
- University of Chicago Comprehensive Cancer Center · Chicago, IL 60637Site Public Contact · Study contact · 773-702-8222 · cancerclinicaltrials@bsd.uchicago.eduChristine M. Bestvina · Principal investigatorMore trials in Chicago
- UC Comprehensive Cancer Center at Silver Cross · New Lenox, IL 60451Site Public Contact · Study contact · 773-702-8222 · cancerclinicaltrials@bsd.uchicago.eduChristine M. Bestvina · Principal investigatorMore trials in New Lenox
- University of Chicago Medicine-Orland Park · Orland Park, IL 60462Site Public Contact · Study contact · 773-702-8222 · cancerclinicaltrials@bsd.uchicago.eduChristine M. Bestvina · Principal investigatorMore trials in Orland Park
MA
- Dana-Farber Cancer Institute · Boston, MA 02215Site Public Contact · Study contact · 877-442-3324Jennifer A. Chan · Principal investigatorMore trials in Boston
MN
- Mayo Clinic in Rochester · Rochester, MN 55905Site Public Contact · Study contact · 855-776-0015Thorvardur R. Halfdanarson · Principal investigatorMore trials in Rochester
MO
- Missouri Baptist Medical Center · St Louis, MO 63131Site Public Contact · Study contact · 314-996-5569Bryan A. Faller · Principal investigatorMore trials in St Louis
NC
- Duke University Medical Center · Durham, NC 27710More trials in Durham
OH
- Case Western Reserve University · Cleveland, OH 44106Site Public Contact · Study contact · 800-641-2422 · CTUReferral@UHhospitals.orgAmr Mohamed · Principal investigatorMore trials in Cleveland
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Site Public Contact · Study contact · 800-293-5066 · Jamesline@osumc.eduVineeth Sukrithan · Principal investigatorMore trials in Columbus
PA
- Fox Chase Cancer Center · Philadelphia, PA 19111Site Public Contact · Study contact · 215-728-4790Sukhmani K. Padda · Principal investigatorMore trials in Philadelphia
- Temple University Hospital · Philadelphia, PA 19140Site Public Contact · Study contact · 215-728-2983Sukhmani K. Padda · Principal investigatorMore trials in Philadelphia
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232Site Public Contact · Study contact · 412-647-8073Liza C. Villaruz · Principal investigatorMore trials in Pittsburgh
TN
- Vanderbilt University/Ingram Cancer Center · Nashville, TN 37232More trials in Nashville
UT
- Huntsman Cancer Institute/University of Utah · Salt Lake City, UT 84112Site Public Contact · Study contact · 888-424-2100 · cancerinfo@hci.utah.eduHeloisa P. Soares · Principal investigatorMore trials in Salt Lake City