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Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Who is this study for? Patients with surgically resectable stage I and II non-small cell lung cancer

What treatments are being studied? IRDye800CW+Nimotuzumab

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

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

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 80

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

Canada

St. Paul's Hospital

RECRUITING

Saskatoon

Contact Information

Primary

Ron Geyer, PhD

ron.geyer@usask.ca

306-966-12040

Time Frame

Start Date: 2020-09-01

Estimated Completion Date: 2026-10

Participants

Target number of participants: 36

Treatments

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

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

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

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

Related Therapeutic Areas

Lung Cancer

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