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Panitumumab-IRDye800 for 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing a new way to find lung cancer during surgery using a combination of the drug panitumumab and an investigational dye called IRDye800CW.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor to background ratio (TBR), measured in ex vivo tissues

Secondary outcome measures

Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments

Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug

Residual disease detection by Panitumumab-IRDye800 versus standard assessments

+1 more

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

~9850

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with certain medical conditions able to participate in this trial right now?

"According to the latest information available on clinicaltrials.gov, this study is no longer recruiting patients. This trial was first posted on July 19th, 2018 and last updated June 21st, 2022. There are presently 3947 other trials that are actively recruiting patients."

Answered by AI

How many individuals are taking part in this clinical trial?

"No, this clinical trial is not admitting patients at the moment. This particular study was first posted on July 19th 2018 and updated June 21st of this year. There are presently 3909 other trials for malignant neoplasms recruiting patients and 38 studies using Panitumumab-IRDye800 looking for participants."

Answered by AI

Are there any other notable clinical trials that have used Panitumumab-IRDye800?

"At the moment, there are 38 separate clinical trials underway for Panitumumab-IRDye800. Out of those, 3 are currently in Phase 3. Most of the studies related to Panitumumab-IRDye800 originate from Nagoya-shi, Aichi; however, 600 different medical facilities worldwide are running trials for this treatment."

Answered by AI

Is this the inaugural study of its kind?

"First studied in 2011, Panitumumab-IRDye800 was initially brought to market by Amgen. The first clinical trial consisted of 75 participants and it received its Phase 2 drug approval soon afterwards. Now, there are 38 active trials for this medication across 16 countries and 151 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

Eben Rosenthal 2018. "Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03582124.