Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT06101394
Eligibility Criteria:
Inclusion criteria:
1. Clinical Stage I non-small cell lung cancer
2. \- Considered candidate to minimally invasive surgical resection after pre-operative assessment
3. Adequate organ function
4. Performance status (ECOG) ≤2
5. Potentially fertile female subjects must agree to use highly effective contraception throughout the - study and for three months after the last dose of the study medication
6. Written informed consent
Exclusion criteria:
1. Previous systemic treatments for lung cancer
2. Previous radiotherapy on lung or mediastinum
3. \- Concomitant disorders that compromise the ability to adhere to the procedures of the Protocol
4. Hemoglobin \< 9 gm/dL
5. Platelet count \< 100,000/mm³
6. Leukocyte count \< 3000/mm³
7. Absolute neutrophil count \< 1500/mm³
8. Magnesium, potassium, and calcium \< the lower limit of normal per institution normal lab values
9. Thyroid-stimulating hormone (TSH) \> 13 micro international units/mL
10. Received an investigational drug within 30 days or 5 half-life prior to the first dose of cetuximab IRDye800
11. Within 6 months prior to enrollment, myocardial infarction; cerebrovascular accident; uncontrolled congestive heart failure; significant liver disease; or unstable angina
12. History of infusion reactions to cetuximab or other monoclonal antibody therapies
13. Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
14. Hypersensitivity to Cetuximab-IRDye800, Cetuximab, or any of the excipients.
15. Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
16. Pregnancy, assessed by a pregnancy serum test (βhCG), or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06101394
Study Brief:
Protocol Section:
NCT06101394