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Panitumumab-IRDye800 for Detecting Lung Cancer

Phase 1 & 2
Recruiting
Led By Natalie Lui
Research Sponsored by Eben Rosenthal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
Must not have
Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Summary

This trial uses a combination of a drug and a glowing dye to help see lung cancer during surgery. It targets lung cancer patients undergoing surgery to improve visibility of the tumor. The drug attaches to cancer cells and the dye makes them glow under a special camera.

Who is the study for?
This trial is for individuals with lung nodules or masses that may be cancerous, scheduled for surgery to remove them. They should have a decent performance status (able to carry out daily activities), normal blood counts, and kidney function within certain limits. It's not for those who've taken experimental drugs recently, are pregnant/breastfeeding, have low magnesium/potassium levels, take specific heart rhythm medications, can't consent on their own, or have had major cardiovascular issues or severe liver disease in the past 6 months.
What is being tested?
The study is testing Panitumumab-IRDye800 during lung cancer surgery to see if it helps identify cancer cells more clearly. This involves combining panitumumab (an antibody drug) with IRDye800CW (a special dye visible with a camera). The goal is to determine the best dose and timing of this combination for enhancing tumor visibility.
What are the potential side effects?
Potential side effects might include reactions similar to those seen with monoclonal antibody therapies such as allergic reactions or infusion-related responses. Since this treatment aims at making tumors visible during surgery rather than treating the cancer itself, typical chemotherapy side effects may not apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery to remove a lung nodule or mass.
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I can take care of myself but may not be able to do active work.
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I have a lung mass that may be cancer, diagnosed or not.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication for heart rhythm problems.
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I have had interstitial pneumonitis or pulmonary fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor to background ratio (TBR), measured in ex vivo tissues
Secondary study objectives
Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (panitumumab-IRDye800, surgery, NIR)Experimental Treatment4 Interventions
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab-IRDye800
2019
Completed Phase 2
~20
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870

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
Common treatments for lung cancer, particularly those similar to Panitumumab-IRDye800, often involve targeted therapies that focus on specific molecules like the epidermal growth factor receptor (EGFR). Panitumumab, for example, binds to EGFR on tumor cells, inhibiting their growth, while IRDye800CW makes these cells visible during surgery. This targeted approach is significant for lung cancer patients as it allows for more precise treatment, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.
Non-Small Cell Lung Cancer beyond Biomarkers: The Evolving Landscape of Clinical Trial Design.Nintedanib: from discovery to the clinic.Is there still room for large registrative trials in unselected cancer patients? The case of anti-epidermal growth factor receptor antibodies in advanced non-small-cell lung cancer.

Find a Location

Who is running the clinical trial?

Eben RosenthalLead Sponsor
8 Previous Clinical Trials
142 Total Patients Enrolled
Natalie LuiPrincipal InvestigatorStanford University

Media Library

Panitumumab-IRDye800 Clinical Trial Eligibility Overview. Trial Name: NCT03582124 — Phase 1 & 2
Lung Cancer Research Study Groups: Diagnostic (panitumumab-IRDye800, surgery, NIR)
Lung Cancer Clinical Trial 2023: Panitumumab-IRDye800 Highlights & Side Effects. Trial Name: NCT03582124 — Phase 1 & 2
Panitumumab-IRDye800 2023 Treatment Timeline for Medical Study. Trial Name: NCT03582124 — Phase 1 & 2
~8 spots leftby Feb 2027