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


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Trial ID: NCT03582124


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. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.

Official Title

A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures

Stanford Investigator(s)

Natalie Shaubie Lui
Natalie Shaubie Lui

Assistant Professor of Cardiothoracic Surgery (Thoracic Surgery)


Inclusion Criteria:

* Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
* 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
* Hemoglobin ≥ 9 gm/dL
* White blood cell count \> 3000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

* Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
* History of infusion reactions to monoclonal antibody therapies
* Pregnant or breastfeeding
* Magnesium or potassium lower than the normal institutional values
* 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
* Prisoners, institutionalized individuals, and patients unable to consent for themselves


procedure: Near-Infrared Fluorescence Imaging

drug: Panitumumab-IRDye800

other: Pharmacokinetic Study

procedure: Therapeutic Conventional Surgery


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jake Jungmin Kim

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