Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

  • End date
    Mar 4, 2024
  • participants needed
  • sponsor
    University of Saskatchewan
Updated on 4 June 2022
platelet count
lung cancer
pulmonary resection
surgery for lung cancer
lung carcinoma


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.

Condition Lung Cancer
Treatment IRDye800CW-nimotuzumab
Clinical Study IdentifierNCT04459065
SponsorUniversity of Saskatchewan
Last Modified on4 June 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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