Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Lung Cancer Clinical Trial

Official title:

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459065
• Other study ID #: CBIRD.20190430.Nimo800CW
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2020
• Est. completion date: October 2026

Study information

• Verified date: January 2024
• Source: University of Saskatchewan
• Contact: Ron Geyer, PhD
• Phone: 306-966-12040
• Email: ron.geyer[@]usask.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• IRDye800CW-nimotuzumab
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

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Western Economic Diversification Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.	To identify the dose with the highest tumor fluorescence and TBR.	up to 14 days
Primary	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.	up to 14 days
Secondary	Determine primary tumor margins.	Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.	up to 14 days
Secondary	Identify EGFR positive lymph nodes.	Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.	up to 14 days
Secondary	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.	up to 14 days