Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients

Inclusion Criteria

• •1. The subjects eligible for the study are those with histologically- or cytologically- documented NSCLC who present stage IIIA disease. Locally advanced patients who present stage IIIA by the previous version can be included if are considered potencially resectable. In case of N2 disease suspicion, pathological assessment by EBUS, mediastinoscopy or thoracotomy has to be carried out for N2 confirmation.
• •2. Tumor should be considered resectable before study entry
• •3. Performance Status of 0 or 1
• •4. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration/inclusion i. WBC ≥ 2000/μL ii. Neutrophils ≥ 1500/μL iii. Platelets ≥ 100 x103/μL iv. Hemoglobin \> 9.0 g/dL v. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): a. Female CrCl = (140 - age in years) x weight in kg x 0.85
• •1\. 72 x serum creatinine in mg/dL
• •b. Male CrCl = (140 - age in years) x weight in kg x 1.00
• •1. 72 x serum creatinine in mg/dL vi. AST/ALT ≤ 3 x ULN vii. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) viii. INR/APTT within normal limits
• •5\. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters
• •6\. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and nacional guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
• •7\. Patients aged \> 18 years
• •8\. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception.
• •9\. Women must not be breastfeeding
• •10\. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.