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Recruiting

NCT Number: NCT04459065

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location status: Recruiting

Location contact

Humphrey Fonge, PhD

SUB_INVESTIGATOR

Kris Barreto, PhD

SUB_INVESTIGATOR

Ronald Geyer, PhD

SUB_INVESTIGATOR

Wendy Bernhard, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IRDye800CW-nimotuzumab

Drug

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 outcomes

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

    Time frame: up to 14 days

    To identify the dose with the highest tumor fluorescence and TBR.

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

    Time frame: up to 14 days

    To identify the imaging time with the highest tumor fluorescence and TBR.

Secondary outcomes

  1. Determine primary tumor margins.

    Time frame: up to 14 days

    Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.

  2. Identify EGFR positive lymph nodes.

    Time frame: up to 14 days

    Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.

  3. Safety of IRDye800CW-nimotuzumab

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ron Geyer, PhD

CONTACT

[email protected]

306-966-12040

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Western Economic Diversification Canada

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2020
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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