- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459065
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
January 5, 2024 updated by: Steven Bharadwaj, University of Saskatchewan
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ron Geyer, PhD
- Phone Number: 306-966-12040
- Email: ron.geyer@usask.ca
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7M 0Z9
- Recruiting
- St. Paul's Hospital
-
Sub-Investigator:
- Ronald Geyer, PhD
-
Sub-Investigator:
- Humphrey Fonge, PhD
-
Sub-Investigator:
- Kris Barreto, PhD
-
Sub-Investigator:
- Wendy Bernhard, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose intermediate time
Participants will receive an i.v.
infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion.
Vitals, blood sample and urine sample will be collected before infusion for a baseline.
Blood and vitals will be taken post infusion.
Blood and urine samples will be collected on the day of surgery.
Participants will be followed up for any adverse event until day 30 post administration
|
50 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
|
Experimental: High dose intermediate time
Participants will receive an i.v.
infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion.
Vitals, blood sample and urine sample will be collected before infusion for a baseline.
Blood and vitals will be taken post infusion.
Blood and urine samples will be collected on the day of surgery.
Participants will be followed up for any adverse event until day 30 post administration
|
50 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
|
Experimental: Optimal dose early time
Participants will receive an i.v.
infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2).
Participants will undergo lung cancer resection surgery 1-3 days after infusion.
Vitals, blood sample and urine sample will be collected before infusion for a baseline.
Blood and vitals will be taken post infusion.
Blood and urine samples will be collected on the day of surgery.
Participants will be followed up for any adverse event until day 30 post administration
|
50 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
|
Experimental: Optimal dose late time
Participants will receive an i.v.
infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2).
Participants will undergo lung cancer resection surgery 7+ days after infusion.
Vitals, blood sample and urine sample will be collected before infusion for a baseline.
Blood and vitals will be taken post infusion.
Blood and urine samples will be collected on the day of surgery.
Participants will be followed up for any adverse event until day 30 post administration
|
50 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
Time Frame: up to 14 days
|
To identify the dose with the highest tumor fluorescence and TBR.
|
up to 14 days
|
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
Time Frame: up to 14 days
|
To identify the imaging time with the highest tumor fluorescence and TBR.
|
up to 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine primary tumor margins.
Time Frame: up to 14 days
|
Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
|
up to 14 days
|
Identify EGFR positive lymph nodes.
Time Frame: up to 14 days
|
Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
|
up to 14 days
|
Safety of IRDye800CW-nimotuzumab
Time Frame: up to 14 days
|
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.
|
up to 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
June 22, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
January 5, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBIRD.20190430.Nimo800CW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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