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

Korábbi kezelés

• Any previous therapy for current lung cancer, including chemotherapy or radiation therapy.
• Concomitant participation in another therapeutic clinical trial.

Más betegség

• Evidence of stage IV NSCLC (metastatic disease).
• Active autoimmune diseases or history of autoimmune diseases that may recur.

Laborértékek

• Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L1.

Egyéb

• Histology of large cell neuroendocrine carcinoma (LCNEC).
• Never smoking patients.
• Pregnancy or breastfeeding.

• 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.