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

   - 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


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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