Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Recruiting
Phase 1Phase 2Interventional Study
Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
University of Saskatchewan · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility 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 thera…
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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