Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

University of Saskatchewan

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lung Cancer

Treatments: Drug: IRDye800CW-nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04459065

CBIRD.20190430.Nimo800CW

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

36 participants in 4 patient groups

Low dose intermediate time

Experimental group

Description:

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

Treatment:

Drug: IRDye800CW-nimotuzumab

High dose intermediate time

Experimental group

Description:

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

Treatment:

Drug: IRDye800CW-nimotuzumab

Optimal dose early time

Experimental group

Description:

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

Treatment:

Drug: IRDye800CW-nimotuzumab

Optimal dose late time

Experimental group

Description:

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

Treatment:

Drug: IRDye800CW-nimotuzumab