Statistical Analysis
NSCLC, SCLC, tumor, DLTs, toxicity, UC
NSCLC, TUMOR, SCLC, EVENT
All patients enrolled in the study who received ≥1 dose of study drug (pembrolizumab, itacitinib, or parsaclisib) comprised the safety analysis population and the full analysis set (FAS) for baseline demographic and efficacy analyses. Descriptive statistics were used to summarize continuous and categorical variables. The exact method for binomial distributions was used to calculate the 95% confidence interval (CI) of ORR. The Kaplan–Meier method was used to estimate duration of response and progression-free survival, including median value and 95% CI.The pharmacokinetic and pharmacodynamic evaluable population included all patients in the FAS who provided at ≥1 plasma sample (≥1 pharmacokinetic or pharmacodynamic measurement). Summary statistics were calculated for pharmacokinetic parameters of itacitinib and parsaclisib, and analysis of pharmacodynamic data. The Wilcoxon matched-pairs signed-rank test (GraphPad Prism v7.02, GraphPad Software) was used to compare baseline and on-treatment tumor biopsy samples, with changes in TILs deemed significant at In Part 1a, 3 to 6 patients were enrolled in each dose level depending on the occurrence of DLTs. In Part 1b, with a planned enrollment of 60 patients [30 patients per expansion cohort A-1/A-2 (itacitinib plus pembrolizumab) and B-1/B-2 (parsaclisib plus pembrolizumab)], there was a ≥90% chance of observing a toxicity with a true event rate of >7.4%. In Part 2, with planned enrollment of a total of 10–29 patients with SCLC in a Simon two-stage design, and 28 patients with NSCLC and 36 patients with UC in a Simon one-stage design, the cohorts were to be terminated for lack of efficacy if there were one or fewer SCLC in stage 1 or five or fewer SCLC total in stage 1 and 2, seven or fewer NSCLC, or ≤13 patients with UC responded to treatment. This was an exploratory study and no formal statistical tests were performed.Effects of treatment on plasma protein biomarkers were determined by paired 