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

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.

Conditions

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Everolimus

Given PO

OTHER

Fludeoxyglucose F-18

Given FDG

DRUG

Lutetium Lu 177 Dotatate

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Thomas A Hope · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-03

Primary Completion

2027-07-01

Completion

2027-07-01

FDA Drug

Yes

Countries

• United States

Study Locations