2.6. Outcomes and Statistical Analyses
toxicity, death, SD
DISEASE, DISEASE PROGRESSION, SECONDARY
The primary endpoint was the ORR in the bTMB-high (bTMBhi) and bTMB-low (bTMBlo) populations. The two groups were divided by the median value of the bTMB at C0 in the ctDNA biomarker-evaluable population (BEP). This trial was an exploratory biomarker study, and the sample size was not based on a statistical calculation.The secondary endpoints were PFS, overall survival (OS), duration of response (DoR), and clinical benefit rate (CBR) in the intention-to-treat (ITT) population and subgroups. The assessment of the toxicity profile was performed in the safety-evaluable ITT population (SEP). PFS was defined as the time (in months) from the first day of atezolizumab treatment to the day of objective disease progression, death or withdrawal of consent. OS was measured from the first day of ICI administration to the day of death, last day of follow-up or withdrawal of consent. DoR was defined as the time from the first day of the confirmed response to the atezolizumab treatment to the day of objective disease progression, death or withdrawal of consent among patients who experienced a complete response (CR) or partial response (PR). Durable clinical benefit (DCB), one of the criteria of CBR, was defined as survival without disease progression (CR + PR + stable disease (SD)) at 24 weeks [Data on PD-L1 TPS, EGFR, ALK and ROS1 alterations were collected based on the tests conducted by each institution. The derived neutrophil-to-lymphocyte ratio (NLR) (dNLR) was calculated as follows: dNLR = absolute neutrophil count [ANC]/(white blood cell count—ANC) [All data were expressed as the mean ± standard deviation (SD) or as the median (range) for the continuous variables and as the number and percentage for the categorical variables. Intergroup comparisons of responses were performed using a Student’s 