Statistical considerations
NSCLC, tumor, Tumor
TUMOR, TUMOR, NSCLC
Up to 48 DLT-evaluable patients were to be enrolled in the escalation cohorts. Up to 280 patients (100 CRC, 100 PDAC, 80 NSCLC) were to be enrolled in the expansion cohorts. For each expansion cohort, an initial interim analysis was performed when the first 20 patients had been enrolled and followed for ≥ 16 weeks, and a second interim analysis was performed after 40 patients had been enrolled and followed for ≥ 16 weeks (Supplementary Methods).Analysis populations are defined in Supplementary Methods. Data were summarized using descriptive statistics. Tumor response was estimated by simple proportions with confidence intervals (CI) calculated using the exact binomial method. Statistical evaluation of translational data used a 2-tailed Student t test. Statistics were performed using GraphPad Prism or R. P-values below 0.05 were considered statistically significant for tumor assessments and adjusted p-values (false discovery rate < 0.05) were considered statistically significant for whole blood assessments.