NCT04459065 Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
| NCT ID | NCT04459065 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Saskatchewan |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2020-09-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2020-09-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04459065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04459065 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04459065 currently recruiting?
Yes, NCT04459065 is actively recruiting participants. Contact the research team at ron.geyer@usask.ca for enrollment information.
Where is the NCT04459065 trial being conducted?
This trial is being conducted at Saskatoon, Canada.
Who is sponsoring the NCT04459065 clinical trial?
NCT04459065 is sponsored by University of Saskatchewan. The trial plans to enroll 36 participants.
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