Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Refusal to sign the Informed Consent Form (ICF).
• NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB.
• Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease.
• Tumor deemed unresectable.
• Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs.
• History of another primary malignancy, with exceptions for:
• Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence.
• Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.
• Adequately treated carcinoma in situ with no evidence of disease.
• Incomplete basic medical information in the electronic medical record.
• Positive for EGFR gene expression.
• Positive for ALK protein expression.
• No available data on PD-L1 protein expression.
• Positive for ROS1 protein expression.
• Pregnant or breastfeeding at the time of enrollment.