Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Saskatchewan
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IRDye800CW-nimotuzumab
Treatment groups
36 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Saskatchewan
Lead sponsor
Western Economic Diversification Canada
Collaborator
Source ClinicalTrials.gov