What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly antibody-based therapies like Panitumumab, often cause side effects such as fatigue, nausea, increased liver function tests, and more severe events like pneumonia, pneumonitis, and rash. Durvalumab, for instance, has shown adverse events including diarrhea, pneumonitis, rash, and pruritus. Immunotherapies like pembrolizumab and nivolumab can also lead to immune-related adverse events such as colitis, hepatitis, and endocrinopathies.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies and targeted therapies for the treatment of lung cancer. For instance, Nivolumab and Atezolizumab are approved for use in patients with progression after chemotherapy. These drugs target the PD-1/PD-L1 pathway to enhance the immune system's ability to fight cancer. Additionally, Trastuzumab deruxtecan is approved for patients with HER2-mutant NSCLC who have received prior systemic therapy. While Panitumumab itself has not shown significant benefits in NSCLC, it is being studied in combination with IRDye800CW to improve surgical outcomes by making tumor cells more visible.

What other types of research exist?

Promising alternatives to Panitumumab-IRDye800 for lung cancer patients include the use of other monoclonal antibodies such as Atezolizumab and Pembrolizumab, which target PD-L1 and PD-1 respectively, and have shown efficacy in lung cancer treatment. Additionally, novel imaging agents like 18F-FDG PET/CT scans and other investigational dyes or radiotracers that enhance tumor visibility during surgery are also being explored. These alternatives are in various stages of clinical trials and may offer new options for lung cancer patients in 2024.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~9630

0 / 5Eligibility criteria met

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.