Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• •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.