Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

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.

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 to enrollment
• Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
• Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug