Testing Lutetium Lu 177 Dotatate in Patients with Advanced Bronchial Neuroendocrine Tumors with Somatostatin Receptors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04665739

Provider View

This study is exploring whether a new treatment, lutetium Lu 177 dotatate, is more effective than the usual treatment, everolimus, for patients with advanced bronchial neuroendocrine tumors that have spread. The treatment uses radiation to target tumor cells while minimizing damage to normal cells.

Patient Parameters

Program Overview

This phase II clinical trial is comparing the effects of a new treatment, lutetium Lu 177 dotatate, with the standard treatment, everolimus, in patients with advanced bronchial neuroendocrine tumors that have spread. The study aims to see if lutetium Lu 177 dotatate can better shrink or stabilize these tumors by delivering radiation directly to the cancer cells, potentially causing less harm to normal cells.

Description

The main goal of this study is to compare how long patients live without their disease getting worse when treated with lutetium Lu 177 dotatate versus everolimus. Researchers will also look at overall survival rates, how well the tumors respond to each treatment, and the side effects of both treatments.

The study will also explore any long-term side effects of lutetium Lu 177 dotatate, such as kidney problems or blood disorders, and how the amount of disease before treatment affects the response to the therapy.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive lutetium Lu 177 dotatate through an IV every 56 days for up to 4 cycles, as long as the disease does not progress or side effects are manageable. They will undergo various scans and tests, including PET, CT, or MRI, and provide blood and tissue samples.

  • Group 2: Will take everolimus orally every day in 28-day cycles, continuing as long as the disease does not progress or side effects are manageable. If the disease progresses, they may switch to Group 1. They will also undergo similar scans and tests as Group 1.

After completing the study treatment, participants will have follow-up visits every 3 months until the disease progresses, and then every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of a well- or moderately-differentiated neuroendocrine tumor of the bronchial (lung) origin.
  • Tumors must show somatostatin receptor positivity on specific PET scans.
  • Must have measurable disease as defined by standard criteria.
  • Must be 18 years or older.
  • Must have adequate blood counts and organ function.
  • Must not be pregnant or nursing and agree to use effective contraception if of childbearing potential.
  • Must not have received certain prior treatments, including peptide receptor radionuclide therapy or mTOR inhibitors.
  • Must have completed any major surgery or prior cancer treatments within specified timeframes before joining the study.
  • Must not have any other active cancer requiring treatment.
  • Must not have active hepatitis B or C, or uncontrolled infections.
  • Must not have received live vaccines recently.
  • Must not have certain medical conditions that affect drug absorption or cause hypersensitivity to study drugs.

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