Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer

Sample size calculation： The primary endpoint is the 2-year DFS rate，however, due to the extended observation time required for this endpoint, it is not suitable for promptly validating treatment response. MPR rate is employed to calculate the necessary sample size. Simon's optimal two-stage design is utilized. The addition of sintilimab to chemotherapy is assumed to elevate the MPR rate from 8.9% to 35%. The sample size should be 29(17+12). In the first stage, the study will be concluded if ≤2 patients achieve MPR, indicating a negative outcome. Conversely, if more than 4 patients achieve MPR, the study will proceed by enrolling an additional 12 patients. Considering the sample size calculation results and sufficient funding, the final enrollment is 30. The type 1 error rate is 0.05. The outlined protocol yield an 95% statistical power to detect an MPR rate of 35% under alternative hypotheses. MRD detectition： Using previously retained biomarkers from patients for MRD detection, exploring the relationship between MRD and patient DFS and OS.