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Radioactive Drug

Lutetium Lu 177 Dotatate for Lung Carcinoid Tumor

Phase 2
Recruiting
Led By Thomas A Hope
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmation of disease progression by RECIST v1.1 by real-time Alliance ICL at IROC Ohio central radiographic review
PRE-REGISTRATION: Recurrent or locally-advanced/unresectable or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from study registration
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the effect of lutetium Lu 177 dotatate in patients with advanced bronchial neuroendocrine tumors. Lutetium Lu 177 dotatate targets cancer cells with radiation, aiming to kill or shrink them while sparing healthy cells. The goal is to see if it works better than the usual treatment. Everolimus has been shown to help patients with various types of neuroendocrine tumors.

Who is the study for?
Adults with advanced bronchial neuroendocrine tumors that are well- or moderately-differentiated and have shown growth. They must not be pregnant, should have an ECOG performance status of 0-2, adequate organ function, no prior treatment with certain drugs like PRRT or mTOR inhibitors, and no active hepatitis B/C or other infections. Tumors must show somatostatin receptor positivity on specific PET scans.
What is being tested?
The trial is testing the effectiveness of Lutetium Lu 177 Dotatate compared to Everolimus in patients with advanced bronchial neuroendocrine tumors. It aims to see if this radioactive drug can better target tumor cells while sparing normal ones.
What are the potential side effects?
Possible side effects include nausea, vomiting, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver toxicity which might affect its function and kidney damage due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has grown or spread as confirmed by a specific scan review.
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My cancer has returned, cannot be surgically removed, or has spread.
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I can take care of myself and perform daily activities.
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I don't have any other cancer needing treatment during the study, except for non-dangerous skin cancers or early-stage breast or cervical cancer.
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I am able to get out of my bed or chair and move around.
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My lung neuroendocrine tumor is confirmed to be well- or moderately-differentiated.
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My cancer has come back, cannot be surgically removed, or has spread.
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I am not allergic to everolimus or similar medications.
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My cancer is not a high-grade neuroendocrine or mixed tumor type.
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I had major surgery and fully healed at least 28 days ago.
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I have never been treated with mTOR inhibitors.
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My cancer is not a high-grade neuroendocrine or mixed tumor.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My cancer originates from the lung's neuroendocrine cells.
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My cancer can be measured and is at least 1 cm in size, or 1.5 cm if it's in the lymph nodes.
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I can swallow normally and my stomach and intestines absorb medications as they should.
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I am 18 years old or older.
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I have never had PRRT treatment.
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My cancer can be measured on scans according to specific criteria.
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My lung tumor is a type of slow-growing cancer confirmed by a pathology report.
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I do not have liver cirrhosis.
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My pathology report identifies my tumor as a certain type of neuroendocrine or carcinoid tumor.
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My tumor is a well- or moderately-differentiated neuroendocrine type.
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My tumor is a low- or intermediate-grade neuroendocrine or carcinoid type.
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My cancer originates from the lung's neuroendocrine cells.
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I have never had lung inflammation from medication that needed treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from study registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from study registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median progression-free survival (PFS)
Secondary study objectives
Incidence of adverse events
Overall response rate (ORR)
Overall survival (OS)
Other study objectives
Incidence of late toxicities of lutetium Lu 177 dotatate therapy
Response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (lutetium Lu 177 dotatate)Experimental Treatment6 Interventions
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.
Group II: Arm II (everolimus)Active Control6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2011
Completed Phase 2
~2200
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~320
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Neuroendocrine Tumors (NETs) include somatostatin analogs, targeted therapies like everolimus, and peptide receptor radionuclide therapy (PRRT) such as Lutetium Lu 177 dotatate. Somatostatin analogs work by binding to somatostatin receptors on tumor cells, inhibiting hormone secretion and tumor growth. Everolimus targets the mTOR pathway, which is involved in cell growth and proliferation, thereby slowing tumor progression. PRRT, like Lutetium Lu 177 dotatate, delivers targeted radiation to tumor cells expressing somatostatin receptors, causing DNA damage and cell death. These mechanisms are crucial for NET patients as they offer targeted approaches to control tumor growth, manage symptoms, and potentially improve quality of life.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,012,036 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,665 Patients Enrolled for Neuroendocrine Tumors
Thomas A HopePrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Lutetium Lu 177 Dotatate (Radioactive Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04665739 — Phase 2
Neuroendocrine Tumors Research Study Groups: Arm I (lutetium Lu 177 dotatate), Arm II (everolimus)
Neuroendocrine Tumors Clinical Trial 2023: Lutetium Lu 177 Dotatate Highlights & Side Effects. Trial Name: NCT04665739 — Phase 2
Lutetium Lu 177 Dotatate (Radioactive Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04665739 — Phase 2
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