Panitumumab-IRDye800 for Detecting Lung Cancer

Overseen By Natalie Lui

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Stanford University

Must not be taking: Antiarrhythmics

Disqualifiers: Recent MI, CHF, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special drug-dye combination, panitumumab-IRDye800, can help identify lung cancer during surgery. By making cancer cells glow, the dye assists surgeons in seeing and removing them more easily. It is suitable for individuals with a lung nodule or mass suspected to be cancer who are planning surgery. Participants receive the treatment via IV and then undergo surgery within a few days. The study aims to determine the optimal dose and timing for using this tool in surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience this innovative approach.

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 prior data suggests that panitumumab-IRDye800 is safe for detecting lung cancer?

Research has shown that panitumumab-IRDye800 is generally safe and well-tolerated. In one study, when used to enhance cancer visibility during surgery, only about 7.4% of participants experienced side effects, indicating that most did not have serious reactions. This treatment combines an antibody and a dye to attach to tumor cells, aiding doctors in visualizing cancer during surgery. Although the dye, IRDye800, is still under investigation, results for safety are promising. Overall, current research suggests the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for lung cancer, which often involve surgery, radiation, and chemotherapy, Panitumumab-IRDye800 stands out because it combines a targeted therapy with a fluorescent dye. This unique combination allows doctors to more precisely identify cancerous tissues during surgery. Panitumumab, an antibody, specifically binds to cancer cells, and the attached IRDye800 makes those cells glow under near-infrared light. This innovative approach aims to improve surgical outcomes by ensuring more complete removal of tumors while sparing healthy tissue. Researchers are excited about this treatment because it has the potential to make surgeries more effective and less invasive.

What evidence suggests that panitumumab-IRDye800 is effective for detecting lung cancer?

Research has shown that Panitumumab-IRDye800, which participants in this trial will receive, helps make tumors easier to see during surgery by targeting a protein called EGFR, often found in cancer cells. Animal studies have demonstrated its effectiveness. Early results from studies with patients who have oropharyngeal cancer are promising, showing improved visibility of tumors. Panitumumab is already used to treat some cancers, supporting its potential usefulness. While specific data for lung cancer is still being collected, these findings suggest that Panitumumab-IRDye800 could enhance the visibility of lung cancer tumors during surgery. ^{1 3 4 6}

Who Is on the Research Team?

Natalie Lui

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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

I have had interstitial pneumonitis or pulmonary fibrosis.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Panitumumab-IRDye800

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.

How Is the Trial Designed?

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?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Eben Rosenthal

Lead Sponsor

Trials

9

Recruited

200+

Published Research Related to This Trial

The study demonstrated that the fluorescently labeled antibodies cetuximab-IRDye800CW and panitumumab-IRDye800CW are safe for use in surgical imaging, with minimal toxicities observed in 27 patients with head and neck squamous cell carcinoma.

Both antibodies showed similar pharmacodynamic properties, and no significant safety concerns were raised, indicating potential for other therapeutic antibodies to be repurposed for imaging with limited preclinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers. Gao, RW., Teraphongphom, N., de Boer, E., et al.[2019]

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]

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]

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]

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 metastatic colorectal cancer (CRC) in patients with RAS wild-type tumors, showing clinical efficacy in various treatment settings, including as a monotherapy in the third-line setting.

The drug is generally well-tolerated, with low rates of infusional reactions, but common side effects like skin rash, diarrhea, and hypomagnesaemia require monitoring and preemptive management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panitumumab safety for treating colorectal cancer. Stremitzer, S., Sebio, A., Stintzing, S., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03582124

Study Details | NCT03582124 | Panitumumab-IRDye800 in ... This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03582124?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(panitumumab%20imaging))&rank=8

IRDye800 in Detecting Cancer in Participants With Lung ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. aacrjournals.org aacrjournals.org/clincancerres/article/30/18/4016/747459/Interim-Phase-II-Results-Using-Panitumumab

Interim Phase II Results Using Panitumumab-IRDye800CW ... Interim Phase II results using Panitumumab-IRDye800CW during transoral robotic surgery in patients with oropharyngeal cancer.

4. withpower.com withpower.com/trial/phase-2-lung-neoplasms-6-2018-3e333?lat=34.60184&lng=-117.81218

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4241857/

Synthesis and biological evaluation of panitumumab ... We developed clinical-quality panitumumab-IRDye800 and evaluated its specificity and sensitivity to visualize tumors by fluorescence imaging.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32880818/

Safety and Stability of Antibody-Dye Conjugate in Optical ... Panitumumab-IRDye800CW was safe and stable to administer over a 54-month window with a low rate of adverse events (7.4 %) which is consistent with the rate ...