Using a special dye to improve lung cancer surgery
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
This study is testing a special dye during lung cancer surgery to see if it helps doctors find and remove tumors more effectively for patients with lung cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Saskatchewan Academic / other |
| Drugs / interventions | cetuximab, panitumumab, necitumumab, nimotuzumab |
| Locations | 1 site (Saskatoon, Saskatchewan) |
| Trial ID | NCT04459065 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and optimal dosage of IRDye800CW-nimotuzumab, a near-infrared imaging probe, during lung cancer surgery. The investigational product targets cancer cells that over-express EGFR, allowing for better visualization of tumors during surgical resection. By enhancing the identification of cancerous tissues, the study aims to improve surgical outcomes for patients with lung cancer. The trial includes both Phase 1 and Phase 2 assessments to ensure thorough evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with surgically resectable Stage I and II non-small cell lung cancer.
Not a fit: Patients with a history of anti-EGFR antibody therapy or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical removal of lung tumors, potentially improving patient outcomes.
How similar studies have performed: While the use of imaging probes in surgery is an emerging field, similar approaches have shown promise in other types of cancers, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saskatoon, Saskatchewan
- St. Paul's Hospital — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Study coordinator: Ron Geyer, PhD
- Email: ron.geyer@usask.ca
- Phone: 306-966-12040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.