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OncoMatch/Clinical Trials/NCT04459065

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Is NCT04459065 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies IRDye800CW-nimotuzumab for lung cancer.

Phase 1/2RecruitingUniversity of SaskatchewanNCT04459065Data as of May 2026

Treatment: IRDye800CW-nimotuzumabThe 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage I, II

Performance status

KARNOFSKY/ECOG/ZUBROD 0–2

Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab)

Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug

Cannot have received: neoadjuvant therapy

No neoadjuvant therapy

Lab requirements

Blood counts

Hemoglobin (hgb) ≥ 90 g/L; White blood cell count (WBC) > 3 x 10^9/L; Platelet count (plt) ≥ 100 x 10^9/L

Kidney function

Serum creatinine ≤ 1.5 times upper reference range

Cardiac function

Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon

Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon; Hemoglobin (hgb) ≥ 90 g/L; White blood cell count (WBC) > 3 x 10^9/L; Platelet count (plt) ≥ 100 x 10^9/L; Serum creatinine ≤ 1.5 times upper reference range

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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