Panitumumab-IRDye800 for Detecting Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Natalie Lui

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Eben Rosenthal

Must not be taking: Antiarrhythmics

Disqualifiers: Recent MI, CHF, Liver disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking certain heart rhythm medications (class IA or class III antiarrhythmic agents), you may not be eligible to participate.

What data supports the effectiveness of the drug Panitumumab-IRDye800 for detecting lung cancer?

Research shows that Panitumumab-IRDye800 is effective in detecting tumors that express EGFR (a protein often found in cancer cells) in animal models, suggesting it could help identify lung cancer. Additionally, Panitumumab, a component of the drug, has been effective in treating other cancers like colorectal cancer, which supports its potential usefulness in lung cancer detection. ^{1 2 3 4 5}

How is the drug panitumumab-IRDye800 unique for detecting lung cancer?

Panitumumab-IRDye800 is unique because it combines a drug that targets the epidermal growth factor receptor (EGFR) with a fluorescent dye, allowing doctors to see cancer cells during surgery. This helps in precisely identifying and removing tumors, which is different from standard treatments that do not provide real-time visual guidance. ^{1 2 3 4 6}

Research Team

Natalie Lui

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for surgery to remove a lung nodule or mass.

I can take care of myself but may not be able to do active work.

I have a lung mass that may be cancer, diagnosed or not.

Exclusion Criteria

I am taking medication for heart rhythm problems.

Prisoners, institutionalized individuals, and patients unable to consent for themselves

Pregnant or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive panitumumab-IRDye800 intravenously over 60 minutes on day 0, followed by NIR imaging and surgery within 1-5 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for up to 1 year to assess long-term outcomes such as tumor-positive lymph node detection and residual disease detection

Up to 1 year

Treatment Details

Interventions

• Panitumumab-IRDye800 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Diagnostic (panitumumab-IRDye800, surgery, NIR) Experimental Treatment 4 Interventions

Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.

Who Is Running the Clinical Trial?

Eben Rosenthal

Lead Sponsor

Trials

9

Recruited

200+

Findings from Research

Panitumumab-IRDye800 has been developed as an effective intraoperative optical imaging agent for detecting EGFR-expressing tumors, showing high specificity and sensitivity in various mouse models with different levels of EGFR expression.

The study demonstrated a strong correlation between the level of EGFR expression in tumors and the uptake of the panitumumab-IRDye800, indicating its potential for precise tumor visualization during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and biological evaluation of panitumumab-IRDye800 conjugate as a fluorescence imaging probe for EGFR-expressing cancers. Bhattacharyya, S., Patel, N., Wei, L., et al.[2020]

Panitumumab is an effective treatment for RAS wild-type metastatic colorectal cancer, approved for use both in combination with chemotherapy and as a standalone therapy for patients who do not respond to chemotherapy.

The review will also discuss the safety profile of panitumumab and its impact on quality of life, along with insights into predictive biomarkers and mechanisms of resistance that can affect treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of panitumumab treatment on survival and quality of life in patients with RAS wild-type metastatic colorectal cancer. Battaglin, F., Puccini, A., Ahcene Djaballah, S., et al.[2020]

In a phase 2 study involving patients with untreated advanced non-small-cell lung cancer, the addition of panitumumab to carboplatin and paclitaxel did not improve the time to progression (TTP) compared to carboplatin and paclitaxel alone, with TTP being 18.1 weeks for the combination and 23.0 weeks for the control group.

While the combination treatment was associated with manageable and predictable toxicities, including skin issues and gastrointestinal symptoms, it did not enhance the overall efficacy, as indicated by similar progression-free survival and objective response rates between the two treatment arms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2 randomized trial of paclitaxel and carboplatin with or without panitumumab for first-line treatment of advanced non-small-cell lung cancer. Crawford, J., Swanson, P., Schwarzenberger, P., et al.[2018]

The anti-EGFR antibody panitumumab-IRDye800 was found to be safe and effective for imaging high-grade gliomas (HGGs) in 11 patients, with no adverse events reported at both low (50 mg) and high (100 mg) doses.

This imaging agent demonstrated high sensitivity (95%) and specificity (96%) for detecting tumor tissue, allowing for improved intraoperative visualization of tumors, which could enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EGFR-targeted intraoperative fluorescence imaging detects high-grade glioma with panitumumab-IRDye800 in a phase 1 clinical trial. Zhou, Q., van den Berg, NS., Rosenthal, EL., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Synthesis and biological evaluation of panitumumab-IRDye800 conjugate as a fluorescence imaging probe for EGFR-expressing cancers. [2020]

2. Australia pubmed.ncbi.nlm.nih.gov

Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Panitumumab safety for treating colorectal cancer. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

The impact of panitumumab treatment on survival and quality of life in patients with RAS wild-type metastatic colorectal cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A phase 2 randomized trial of paclitaxel and carboplatin with or without panitumumab for first-line treatment of advanced non-small-cell lung cancer. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

EGFR-targeted intraoperative fluorescence imaging detects high-grade glioma with panitumumab-IRDye800 in a phase 1 clinical trial. [2021]