Actively Recruiting
Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
70
Participants Needed
29
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating lutetium Lu 177 dotatate compared to the standard treatment everolimus in adults with advanced somatostatin receptor positive bronchial neuroendocrine tumors that have spread in the body. This phase II trial aims to compare how long patients live without their disease getting worse and overall survival, as well as response rates and side effects of each treatment. The study also explores late side effects and the impact of tumor characteristics on treatment response. Participants are randomly assigned to receive either lutetium Lu 177 dotatate intravenously over 30-40 minutes every 56 days for up to 4 cycles or everolimus taken orally once daily in 28-day cycles until disease progression or unacceptable side effects. Patients in the everolimus group may switch to lutetium Lu 177 dotatate if their disease worsens. Before and during treatment, patients undergo imaging tests such as PET, CT, MRI, FDG PET, and SPECT scans, along with blood and tissue sample collections. During the study, patients are monitored with scans and sample collections to assess tumor response, side effects, and overall health. After treatment ends, follow-up visits occur every 3 months until the disease progresses, then every 6 months for up to 5 years. The primary measurement is progression-free survival, with other outcomes including overall survival, response rates, and adverse events. The total participation time may last several years to monitor long-term effects and disease status.
CONDITIONS
Brief Title
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Well- or moderately-differentiated neuroendocrine tumor of bronchial (lung) origin confirmed by pathology
- Evidence of somatostatin receptor positivity on PET scan within 12 months prior to registration
- Measurable disease by CT or MRI with lesions ≥1 cm in longest diameter
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate blood counts and organ function as defined by hemoglobin ≥8.0 g/dL, platelet count ≥75,000/mm³, ANC ≥1,500/mm³, creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL/min, total bilirubin ≤2.0 x ULN, albumin ≥2.8 g/dL, AST/ALT ≤3.0 x ULN
- Not pregnant or nursing; negative pregnancy test if applicable
- No prior treatment with peptide receptor radionuclide therapy or mTOR inhibitors
- Prior anticancer therapies completed at least 28 days before registration with recovery from toxic effects
- No active uncontrolled infections or decompensated liver cirrhosis
- No known hypersensitivity to everolimus or related drugs
- Patients with HIV on effective therapy with undetectable viral load are eligible
- No known active hepatitis B or C unless controlled with therapy
- No known central nervous system metastases unless treated and stable for at least 14 days
You will not qualify if you...
- Poorly-differentiated or high-grade neuroendocrine carcinoma such as large cell neuroendocrine carcinoma or small cell lung cancer
- Mixed tumors like adenocarcinoid tumor
- Non-measurable disease or lesions smaller than required size
- Prior peptide receptor radionuclide therapy or mTOR inhibitor treatment
- Active malignancy requiring therapy other than specified exceptions
- Active uncontrolled infections requiring antifungal or antibiotic treatment
- Receipt of live attenuated vaccines within 7 days prior to registration
- Known drug-induced pneumonitis requiring treatment
- Medical conditions impairing swallowing or absorption of oral medications
- Concurrent use of strong CYP3A4 inhibitors or inducers not discontinued 7 days before registration
- Decompensated liver cirrhosis
- Pregnant or nursing women
- Unstable steroid use or unstable central nervous system metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 months for lutetium Lu 177 dotatate or longer for everolimus depending on disease progression
Participants receive either lutetium Lu 177 dotatate intravenously every 56 days for up to 4 cycles, or everolimus orally once daily in 28-day cycles, continuing until disease progression or unacceptable toxicity.
1 infusion visit every 56 days for up to 4 cycles or daily oral dosing with regular assessments
Duration - Up to 5 years
After completing treatment, participants are followed every 3 months until disease progression and then every 6 months for up to 5 years for monitoring long-term outcomes and late toxicities.
Visits every 3 months initially, then every 6 months
Trial Site Locations
Total: 29 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Withdrawn
2
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
Actively Recruiting
3
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
6
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States, 90505
Actively Recruiting
7
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Suspended
9
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
11
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
12
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
13
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
14
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
15
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
16
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
17
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
18
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
19
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
20
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
21
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
Actively Recruiting
22
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
23
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
25
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Suspended
26
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
27
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
28
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
29
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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