Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy
The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.
• Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol.
• Male or female, aged 18 years or older.
• Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA.
• Receiving treatment at Hospital de Base.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose.
• Tumor sample meets the following requirements:
• Negative for EGFR gene expression.
• Negative for ALK and ROS1 protein expression.
• PD-L1 protein expression documented and assessable.
• Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review.
• Adequate organ and bone marrow function as defined below:
• Hemoglobin: ≥ 9.0 g/dL\*
• Absolute neutrophil count: ≥ 1.5 × 10\^9 /L\*
• Platelet count: ≥ 100 × 10\^9 /L\*
• \*Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values.
• Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation.
• ALT and AST: ≤ 2.5 × ULN.
• Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula).
• Life expectancy greater than six months prior to randomization.