Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

CBIRD.20190430.Nimo800CW

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.

2020-09-01

2026-09-01

2026-10-01

Recruiting

Early phase I

36

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2024-01-09