Recruiting
Phase 1
Phase 2

IRDye800CW-Nimotuzumab

Sponsor:

University of Saskatchewan

Code:

NCT04459065

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IRDye800CW-nimotuzumab

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT04459065

Start date

Sep 1, 2020

Status verified date

Jan, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery. [ Time Frame: up to 14 days ]
  • Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery. [ Time Frame: up to 14 days ]

Central Contacts and Locations

Central contacts

Ron Geyer, PhD

306-966-12040ron.geyer@usask.ca

Locations

St. Paul's Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7M 0Z9

More Information

Sponsor

University of Saskatchewan

Last update posted

Jan 9, 2024

Last verified

Jan, 2024

Keywords

  • IRDye800CW
  • Nimotuzumab
  • Lung cancer
  • EGFR
  • Near infrared
  • Image guided surgery
  • Optical imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2024-01-09.