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Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Lung Cancer

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 80

Participation 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

Study Location

St. Paul's Hospital
St. Paul's Hospital
Saskatoon, Saskatchewan
Canada

Contact Study Team

Study Sponsored By
University of Saskatchewan
Participants Required
More Information
Study ID: NCT04459065