Clinical trial NCT04459065: Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Official title: Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: IRDye800CW
Nimotuzumab
Lung cancer
EGFR
Near infrared
Image guided surgery
Optical imaging
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Western Economic Diversification Canada
First posted: 2020-07-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
timeFrame: up to 14 days
measure: Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
timeFrame: up to 14 days
Secondary outcomes:
measure: Determine primary tumor margins.
timeFrame: up to 14 days
measure: Identify EGFR positive lymph nodes.
timeFrame: up to 14 days
measure: Safety of IRDye800CW-nimotuzumab
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: St. Paul's Hospital
state: Saskatchewan
Study officials:
References: