Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04665739

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

70

Participants Needed

29

Research Sites

229 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of well- or moderately-differentiated neuroendocrine tumor of bronchial origin (carcinoid tumor)
  • Tumors may be functional or nonfunctional
  • Recurrent, locally advanced/unresectable, or metastatic disease
  • Tumor progression documented within 12 months prior to registration
  • Somatostatin receptor positivity confirmed by PET scan within 12 months prior to registration
  • Measurable disease by CT or MRI with lesions at least 1 cm (or lymph nodes 1.5 cm short axis)
  • No prior treatment with peptide receptor radionuclide therapy (e.g., lutetium Lu 177 dotatate)
  • No prior treatment with mTOR inhibitors (e.g., everolimus, sirolimus)
  • Completion of prior therapies at least 28 days before registration (except somatostatin analogs under conditions)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate blood counts and organ function as specified
  • Not pregnant or nursing; women of childbearing potential must have negative pregnancy test
  • No known active central nervous system metastases unless treated and stable
  • No other active malignancy requiring therapy during study
  • No known active hepatitis B or C; HIV patients on effective therapy eligible
  • No active or uncontrolled infections requiring ongoing treatment
  • No prior symptomatic drug-induced pneumonitis
  • Ability to swallow and absorb oral medications
  • No hypersensitivity to everolimus or similar drugs
  • Allowed concurrent somatostatin analog use in functional tumors with prior progression on these agents
  • Discontinuation of P-gp and strong CYP3A4 inhibitors/inducers 7 days prior to registration on everolimus arm
Not Eligible

You will not qualify if you...

  • Poorly-differentiated or high-grade neuroendocrine carcinoma (e.g., large cell neuroendocrine carcinoma, small cell lung cancer)
  • Mixed tumors such as adenocarcinoid tumor
  • Pregnancy or nursing
  • Known decompensated liver cirrhosis
  • Current symptomatic drug-induced pneumonitis
  • Known active central nervous system metastases unless treated and stable
  • Other currently active malignancy requiring treatment during the study (excluding certain skin or in situ cancers)
  • Known active hepatitis B or C infection without control
  • Active or uncontrolled infections requiring antifungals or antibiotics
  • Inability to swallow or absorb oral medications
  • Known hypersensitivity to everolimus or similar drugs
  • Use of P-gp and strong CYP3A4 inhibitors or inducers within 7 days prior to registration on everolimus arm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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