Statistical analysis
NSCLC
NSCLC
Based on the earlier trials for NSCLC patients with previously treated, the sample size was calculated to ensure the median PFS in each group exceeded 2 months. The assumptions of an expected median PFS of 3 months, 5% one‐sided significance level and 80% power, and an estimated of 2 years of enrollment and 1 year of follow‐up necessitated the inclusion of at least 37 patients in each arm. We planned to enroll 80 patients for the trial, accounting for dropout.For each group, the cumulative PFS probability and median PFS were estimated using the Kaplan–Meier method. The 95% confidence interval (CI) for median PFS was estimated using the Brookmeyer and Crowley method. A test based on the maximum likelihood method for hazard assuming an exponential distribution was performed for the null hypothesis that the median PFS would be 2 months for each group. The hazard ratio (HR) was calculated using the Cox proportional hazards model. For each group, we estimated the ORR and the 95% CI. For reference, Fisher's exact test was used to make the null hypothesis that the ORRs between groups are equal. All statistical analysis was performed with SAS 9.4 software.