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NCT04665739 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lung Neuroendocrine Neoplasm and Locally Advanced Lung Neuroendocrine Neoplasm, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
70
Enrollment target
20
Study locations

NCT04665739: Recruiting Phase 2 study of Lung Neuroendocrine Neoplasm and Locally Advanced Lung Neuroendocrine Neoplasm, sponsored by National Cancer Institute (NCI).

NCT04665739 is a Phase 2 study of Lung Neuroendocrine Neoplasm and Locally Advanced Lung Neuroendocrine Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 913-participant average among 3 other Lung Neuroendocrine Neoplasm trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04665739, a Phase 2 study of Lung Neuroendocrine Neoplasm and Locally Advanced Lung Neuroendocrine Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

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.

Conditions Studied

Lung Neuroendocrine Neoplasm Locally Advanced Lung Neuroendocrine Neoplasm Lung Neuroendocrine Tumor G2 Metastatic Lung Neuroendocrine Neoplasm Advanced Lung Neuroendocrine Tumor Functioning Lung Neuroendocrine Tumor Lung Neuroendocrine Tumor G1 Metastatic Lung Neuroendocrine Tumor Non-Functioning Lung Neuroendocrine Tumor Recurrent Lung Neuroendocrine Neoplasm

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Everolimus
  • OTHER Fludeoxyglucose F-18
  • DRUG Lutetium Lu 177 Dotatate

Study Locations (20)

California

  • Tower Cancer Research Foundation - Beverly Hills
  • Loma Linda University Medical Center - Loma Linda
  • Cedars Sinai Medical Center - Los Angeles
  • UCSF Medical Center-Mission Bay - San Francisco
  • Torrance Memorial Physician Network - Cancer Care - Torrance

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation - Plantation

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago
  • UC Comprehensive Cancer Center at Silver Cross - New Lenox
  • University of Chicago Medicine-Orland Park - Orland Park

Iowa

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic - Ankeny
  • Iowa Methodist Medical Center - Des Moines
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic - Des Moines

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-02-03
Est. Completion 2033-01-16
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT04665739 shows while recruiting

NCT04665739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 913-participant average among 3 other Lung Neuroendocrine Neoplasm trials with a reported enrollment target (92% lower).

The record links to 10 conditions, with Lung Neuroendocrine Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04665739 names 20 study sites across 8 states, led by California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT04665739 about?

NCT04665739 is a clinical study titled "Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors". 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 dr...

What is the current status of trial NCT04665739?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-02-03. Estimated completion is 2033-01-16.

What conditions does trial NCT04665739 study?

This clinical trial studies the following conditions: Lung Neuroendocrine Neoplasm, Locally Advanced Lung Neuroendocrine Neoplasm, Lung Neuroendocrine Tumor G2, Metastatic Lung Neuroendocrine Neoplasm, Advanced Lung Neuroendocrine Tumor.

What interventions are being tested in trial NCT04665739?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Everolimus (DRUG), Fludeoxyglucose F-18 (OTHER), Lutetium Lu 177 Dotatate (DRUG).

Who is sponsoring clinical trial NCT04665739?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04665739 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT04665739

Source: ClinicalTrials.gov NCT04665739, the US trial registry maintained by the National Library of Medicine. NCT04665739 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.