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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
IRDye800CW-nimotuzumab
Drug50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion
Treatment groups
36 Participants
are divided into 4 treatment groupsGroup A: Low dose intermediate timeExperimental treatment 1 intervention
Group B: High dose intermediate timeExperimental treatment 1 intervention
Group C: Optimal dose early timeExperimental treatment 1 intervention
Group D: Optimal dose late timeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
To identify the dose with the highest tumor fluorescence and TBR.
Time frame
up to 14 days2
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
To identify the imaging time with the highest tumor fluorescence and TBR.
Time frame
up to 14 daysSecondary outcomes
1
Determine primary tumor margins.
Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
Time frame
up to 14 days2
Identify EGFR positive lymph nodes.
Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
Time frame
up to 14 days3
Safety of IRDye800CW-nimotuzumab
a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration.
Time frame
up to 14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Saskatchewan
Lead sponsor
Western Economic Diversification Canada
Collaborator
Source ClinicalTrials.gov