Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Trial Parameters
Brief Summary
The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.
Eligibility Criteria
Inclusion Criteria: * Surgically resectable Stage I and II non-small cell lung cancer * Able to give informed consent * Age ≥ 18 and ≤ 80 years old * Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon * No prior history of malignancy * No neoadjuvant therapy * Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2 * Hemoglobin (hgb) ≥ 90 g/L * White blood cell count (WBC) \> 3 x 109/L * Platelet count (plt) ≥ 100 x 109/L * Serum creatinine ≤ 1.5 times upper reference range Exclusion Criteria: * Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug * Pregnant or nursing * Known history of hypersensitivities or allergic reactions to antibodies or NSO derived products * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior t