Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)
A Ph.2, single-arm, monocentric, trial of neo-adjiuvant chemo-immunotherapy for stage III, PD-L1 positive, NSCLC. Adults and smokers (past or current) diagnosed with stage III NSCLC without driver molecular alterations (EGFR, ALK, ROS1, RET).
• Histologically confirmed stage III disease.
‣ PD-L1 TPS ≥ 1% according to local testing.
⁃ No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing.
∙ Mandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent.
• Pulmonary function tests within 6 months of the planned resection.
• At least 1 measurable lesion as defined by RECIST v1.1.
• ECOG Performance Status ≤ 1.
• Eligibility to receive a platinum doublet chemotherapy regimen.
• Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug:
∙ Patients must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following:
∙ Absolute neutrophil count ≥ 1.5 x 109 /L Platelets ≥ 75 x 109 /L Hemoglobin ≥ 90 g/L Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 9).
∙ For patients intended to receive cisplatin: creatinine clearance 60mL/min For patients intended to receive carboplatin: creatinine clearance 45mL/min Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (total bilirubin must be \< 3 x ULN for patients with Gilberts syndrome).
∙ AST and ALT ≤ 2.5 x ULN For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time 1.5ULN
• Age ≥ 18 years.
• Written informed consent.