Statistical analysis
The protocol defined two patient populations for the statistical analyses. For the safety analysis, all patients who received at least one dose of study treatment were considered as the safety population. For the efficacy analysis, all patients who received at least two cycles of induction therapy, including at least one administered dose in cycle three, were considered as FAS; the FAS was used for the analysis of all study end points, apart from safety. Given the experimental nature of the study regimen, this FAS definition was chosen to ensure reliable data acquisition on the actual efficacy of the regimen and to reduce interactions— for example, due to comorbidities or non-adherence to study treatment — which was anticipated to be a possible confounder given the heterogeneous clinical presentation of RT. To account for selection bias possibly introduced by this approach, a post hoc analysis was conducted in all patients enrolled in the study (ITT population).The primary end point ORR at the end of induction therapy was used to determine the sample size of the study. The null hypothesis was ORR ≤ 0.40 with the alternative hypothesis of ORR > 0.40. The type I error was set to α = 2.5% and the type II error should not exceed β = 20% to achieve a power of at least (1 − β) = 80%. Based on these parameters, a one-sided one-sample binomial test with an overall significance level of 2.5% provided the sample size of 