Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and tissue sample collection
• Computed Tomography — PROCEDURE
  Undergo CT
• Everolimus — DRUG
  Given PO
• Fludeoxyglucose F-18 — OTHER
  Given FDG
• Lutetium Lu 177 Dotatate — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Single Photon Emission Computed Tomography — PROCEDURE
  Undergo SPECT
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Feb 3, 2023

Status verified

Apr 2026

Primary completion

Jul 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (lutetium Lu 177 dotatate)
  Patients receive lutetium Lu 177 dotatate IV over 30-40 minutes on day 1 of each cycle. Treatment repeats every 56 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.
• Active Comparator: Arm II (everolimus)
  Patients receive everolimus PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may be able to cross-over to Arm I. Patients undergo PET during screening. Patients also undergo CT or MRI during screening and on the trial as well as FDG PET and SPECT on the trial. Additionally, patients undergo blood and tissue sample collection during screening and on the trial.

Primary Outcome Measure

Median progression-free survival (PFS) [ Time Frame: From randomization until either radiographic progression confirmed by central radiology review or death, assessed up to 5 years from study registration ]

Locations (29)

Find similar trials in Birmingham, AL

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