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Monoclonal Antibodies
Radiolabeled Monoclonal Antibody Therapy for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with stage IIIA/B unresectable disease who received prior radiotherapy must show evidence of progressive disease (greater than 25% increase in primary tumor or appearance of new lesions)
No known, active brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well radiolabeled monoclonal antibody therapy works in treating patients with non-small cell lung cancer that has returned or is not responding to treatment.
Who is the study for?
This trial is for adults over 18 with advanced non-small cell lung cancer that's worsened after standard chemotherapy. They should have a life expectancy of at least 3 months, no active brain metastases or serious liver issues, and must not be pregnant or nursing. Participants need normal organ function and blood counts, are HIV negative, and agree to use contraception.Check my eligibility
What is being tested?
The study tests radiolabeled monoclonal antibody therapy in patients with relapsed or refractory non-small cell lung cancer. It aims to see if this treatment can target and kill cancer cells without harming healthy ones.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system targeting normal cells by mistake, radiation exposure from the labeled antibodies affecting healthy tissues, fatigue, allergic responses to the monoclonal antibody component, as well as typical infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My stage IIIA/B cancer has grown more than 25% or spread after radiotherapy.
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I do not have any active cancer spread to my brain.
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My lung function tests show at least 60% FEV1 and 50% DLCO.
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My kidney function, measured by creatinine, is within normal limits.
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My liver functions are within normal limits and I don't have hepatitis B or C.
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I am 18 years old or older.
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I've had one round of standard chemotherapy and, if needed, limited chest radiation.
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My cancer is not adenocarcinoma, but tests show high CEA levels or positive CEA in tissue.
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I do not suffer from severe loss of appetite, nausea, or vomiting.
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My heart pumps well, with an ejection fraction of 50% or more.
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My lung cancer is confirmed to be non-small cell type.
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I can take care of myself and perform daily activities.
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Less than a quarter of my bone marrow is affected by cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,854 Total Patients Enrolled
Garden State Cancer Center at the Center for Molecular Medicine and ImmunologyLead Sponsor
9 Previous Clinical Trials
123 Total Patients Enrolled
Jack D. Burton, MDStudy ChairGarden State Cancer Center at the Center for Molecular Medicine and Immunology
8 Previous Clinical Trials
114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My stage IIIA/B cancer has grown more than 25% or spread after radiotherapy.It has been over 4 weeks since my last major surgery.My stage IIIB or IV cancer has not been treated with radiotherapy and has shown no change or worsened on scans 4 weeks apart.I do not have any active cancer spread to my brain.My kidney function, measured by creatinine, is within normal limits.I've had radiation therapy on less than 30% of my bone marrow.My liver functions are within normal limits and I don't have hepatitis B or C.My lung function tests show at least 60% FEV1 and 50% DLCO.I am 18 years old or older.I've had one round of standard chemotherapy and, if needed, limited chest radiation.My cancer is not adenocarcinoma, but tests show high CEA levels or positive CEA in tissue.I do not suffer from severe loss of appetite, nausea, or vomiting.My heart pumps well, with an ejection fraction of 50% or more.My lung cancer is confirmed to be non-small cell type.It has been over 4 weeks since my last radiation treatment.It has been over 4 weeks since my last chemotherapy session.I have not had a stem cell transplant following intense chemotherapy.I am not using any growth factor medications.I can take care of myself and perform daily activities.Less than a quarter of my bone marrow is affected by cancer.
Research Study Groups:
This trial has the following groups: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.
Has this therapy been validated by the FDA?
"The safety of this novel treatment is estimated to be a 1 on the scale, as it has only been evaluated in Phase One clinical trials and there remains limited data supporting its efficacy."
Answered by AI
Is this trial actively seeking participants?
"This clinical trial, originally posted on August 1st 2000 and last updated February 28th 2009, is not actively recruiting. Nonetheless, there are 2042 other medical studies that are available for participation at this moment in time."
Answered by AI
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