← Back to Search

IRDye800CW-nimotuzumab Imaging for Lung Cancer Surgery

Phase 1 & 2

Recruiting

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 and ≤ 80 years old

Surgically resectable Stage I and II non-small cell lung cancer

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to image tumors during surgery, which may help surgeons better identify and remove cancer cells.

Who is the study for?

This trial is for adults aged 18-80 with Stage I or II non-small cell lung cancer that can be surgically removed. Participants must have good blood counts, no history of other cancers, not received certain anti-cancer drugs recently, and should not be pregnant or nursing. They need to be healthy enough for surgery and without serious heart conditions or lung diseases.

What is being tested?

The study tests IRDye800CW-nimotuzumab as a probe during lung cancer surgery. It's designed to bind to cancer cells making them visible under near-infrared light which may help surgeons remove the tumor more effectively. The trial aims to find the safest dose and best timing for imaging.

What are the potential side effects?

Potential side effects might include allergic reactions due to sensitivity towards antibodies or NSO derived products used in the investigational drug. Specific side effects are not listed but will likely relate to how the body reacts to this new imaging agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old.

Select...

My lung cancer is in an early stage and can be removed with surgery.

Select...

I have not received any initial treatment before the main treatment.

Select...

I can take care of myself but may not be able to do active work.

Select...

I have never had cancer before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication for heart rhythm problems.

Select...

I have had interstitial pneumonitis or pulmonary fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.

Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.

Secondary study objectives

Determine primary tumor margins.

Identify EGFR positive lymph nodes.

Safety of IRDye800CW-nimotuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Optimal dose late timeExperimental Treatment1 Intervention

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

Group II: Optimal dose early timeExperimental Treatment1 Intervention

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

Group III: Low dose intermediate timeExperimental Treatment1 Intervention

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

Group IV: High dose intermediate timeExperimental Treatment1 Intervention

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

0 / 7Eligibility criteria met