Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Phase 1

Recruiting

• Conditions: Lung Cancer
• Interventions: Drug: IRDye800CW-nimotuzumab

• Registration Number: NCT04459065
• Lead Sponsor: University of Saskatchewan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2020-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09
• Primary Completion: 2026-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
High dose intermediate time	IRDye800CW-nimotuzumab	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
Optimal dose late time	IRDye800CW-nimotuzumab	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
Low dose intermediate time	IRDye800CW-nimotuzumab	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
Optimal dose early time	IRDye800CW-nimotuzumab	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

Primary Outcome Measures

Name	Time	Method
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.	up to 14 days	To identify the dose with the highest tumor fluorescence and TBR.
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.	up to 14 days	To identify the imaging time with the highest tumor fluorescence and TBR.

Secondary Outcome Measures

Name	Time	Method
Determine primary tumor margins.	up to 14 days	Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
Identify EGFR positive lymph nodes.	up to 14 days	Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
Safety of IRDye800CW-nimotuzumab	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.

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada