Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT04459065

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Led by University of Saskatchewan · Updated on 2024-01-09

36

Participants Needed

1

Research Sites

317 weeks

Total Duration

On this page

Sponsors

U

University of Saskatchewan

Lead Sponsor

W

Western Economic Diversification Canada

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Surgically resectable Stage I and II non-small cell lung cancer
  • Able to give informed consent
  • Age 18 to 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Paul's Hospital

Saskatoon, Saskatchewan, Canada, S7M 0Z9

Actively Recruiting

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Research Team

R

Ron Geyer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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