Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Western Economic Diversification Canada
• Treatments: Nimotuzumab

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 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