OncoMatch/Clinical Trials/NCT04459065
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Is NCT04459065 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies IRDye800CW-nimotuzumab for lung cancer.
Treatment: IRDye800CW-nimotuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
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
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT04459065 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage I or II is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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