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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
Study Summary
This trial compares lutetium Lu 177 dotatate to the usual treatment, everolimus, for patients with neuroendocrine tumors that have spread to other parts of the body. Lutetium Lu 177 dotatate may be more effective than everolimus and cause less harm to normal cells.
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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years from study registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from study registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median progression-free survival (PFS)
Secondary outcome measures
Incidence of adverse events
Overall response rate (ORR)
Overall survival (OS)
Other outcome measures
Dosimetry of response
Incidence of late toxicities of lutetium Lu 177 dotatate therapy
Pretreatment disease burden
+2 moreTrial 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
2008
Completed Phase 2
~2240
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,921 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,515 Patients Enrolled for Neuroendocrine Tumors
Thomas A HopePrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has grown or spread as confirmed by a specific scan review.My cancer has returned, cannot be surgically removed, or has spread.Your medical history includes information about the type of cancer you have from either the original or secondary site.I can take care of myself and perform daily activities.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.My lung neuroendocrine tumor is confirmed to be well- or moderately-differentiated.I am not pregnant or breastfeeding and, if capable of becoming pregnant, I have a recent negative pregnancy test.My tumor shows positive for somatostatin receptors in recent scans.My cancer has come back, cannot be surgically removed, or has spread.I am able to get out of my bed or chair and move around.I am not allergic to everolimus or similar medications.My cancer is not a high-grade neuroendocrine or mixed tumor type.I finished my cancer treatment 28 days ago, except for somatostatin analogs for my functional tumor.I do not have active hepatitis B or C, or if I have hepatitis B, it is under control with treatment.I finished lung radiation at least 14 days ago for targeted therapy or 28 days ago for regular therapy.I am using somatostatin analogs for a functional tumor that has grown despite the treatment.I had major surgery and fully healed at least 28 days ago.My side effects from previous cancer treatments have mostly gone away.My brain metastases are treated and stable for 2 weeks, and I am on a stable, low dose of steroids.I haven't needed strong infection medicine in the last 3 days.I have never been treated with mTOR inhibitors.I haven't had any live vaccines in the last week.My cancer is not a high-grade neuroendocrine or mixed tumor.My cancer has grown or spread in the last year, as shown by scans.I am not taking any strong medication that affects drug metabolism.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer originates from the lung's neuroendocrine cells.My tumor may or may not be affecting my body's functions.My cancer can be measured and is at least 1 cm in size, or 1.5 cm if it's in the lymph nodes.I can swallow normally and my stomach and intestines absorb medications as they should.I am 18 years old or older.I've had treatments like embolization or ablation for liver cancer, but still have measurable disease or progression.My disease has worsened after previous treatment.I have never had PRRT treatment.I have HIV, am on effective treatment, and my viral load is undetectable.My cancer can be measured on scans according to specific criteria.My lung tumor is a type of slow-growing cancer confirmed by a pathology report.I completed my 90-Yttrium radioembolization treatment over 3 months ago.I do not have liver cirrhosis.My pathology report identifies my tumor as a certain type of neuroendocrine or carcinoid tumor.My tumor is a well- or moderately-differentiated neuroendocrine type.My tumor is a low- or intermediate-grade neuroendocrine or carcinoid type.My cancer originates from the lung's neuroendocrine cells.You need to have documentation of the type of cancer you have from a biopsy of either the primary site or a metastatic site.My cancer has worsened in the last year, as shown by scans.I have never had lung inflammation from medication that needed treatment.My tumor is either affecting my hormone levels or it isn't.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (lutetium Lu 177 dotatate)
- Group 2: Arm II (everolimus)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many venues is this trial being conducted in?
"Tower Cancer Research Foundation in Beverly Hills, Ohio, Torrance Memorial Physician Network - Cancer Care in Torrance, Tennessee, and UCSF Medical Center-Mission Bay in San Francisco are some of the many clinical sites participating in this trial. There are 8 additional locations that have been included as well."
Answered by AI
What is the approximate participation rate of this clinical trial?
"This clinical trial requires 108 individuals that meet the pre-defined qualifications to take part. Patients can participate at Tower Cancer Research Foundation in Beverly Hills, Ohio and Torrance Memorial Physician Network - Cancer Care in Torrance, Tennessee."
Answered by AI
Are there any adverse effects associated with the administration of Lutetium Lu 177 Dotatate?
"Our team at Power assessed the safety of Lutetium Lu 177 Dotatate to be a 2 because, as this is still in Phase 2 trials, there has been some clinical evidence that it can provide safety but none yet showing efficacy."
Answered by AI
What maladies are typically alleviated with Lutetium Lu 177 Dotatate?
"Lutetium Lu 177 Dotatate is regularly prescribed to treat transplant rejection and kidney issues, though it also has proven efficacy in managing Waldenstrom macroglobulinemia, lung tumors, and advanced carcinoid tumours."
Answered by AI
Are new participants being accepted in this research endeavor?
"According to clinicaltrials.gov, recruitment is currently ongoing for this trial which was initially published on September 10th 2021 and most recently updated on the 23rd of September 2022."
Answered by AI
Could you provide an overview of recent trials involving Lutetium Lu 177 Dotatate?
"Lutetium Lu 177 Dotatate was initially examined in 2008 at Sheba Medical Center. At present, 408 trials are finished and 115 live clinical studies are occurring around the world, with a heavy concentration of these experiments taking place in Beverly Hills, Ohio."
Answered by AI
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