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.
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
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
Single group
Near-Infrared Fluorescence Imaging
Procedure/SurgeryUndergo imaging
Panitumumab-IRDye800
DrugGiven IV
Pharmacokinetic Study
Other interventionCorrelative studies
Therapeutic Conventional Surgery
Procedure/SurgeryUndergo surgery
Tumor to background ratio (TBR), measured in ex vivo tissues
The TBR is defined as the near-infrared fluorescence signal of tumor or lymph node tissue compared to normal adjacent tissue measured in ex vivo tissues. Outcomes will be reported as the TBR (mean) and standard deviation for each dose group and timing group (1-2 days or 3-5 days prior to surgery).
Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug
Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify metastatic lesions. Outcomes will be reported as the number of metastatic lesions detected by both near-infrared fluorescence imaging and histopathology, and each method alone.
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify tumor-positive lymph nodes. Outcomes will be reported as the number of tumor-positive lymph nodes detected by both near-infrared fluorescence imaging and histopathology, and each method alone.
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify residual disease at resection margins. Outcomes will be reported as the number of positive-margins detected by both near-infrared fluorescence imaging and histopathology, and each method alone.
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