Statistical methods
REGRESSION, RECRUITMENT
Up to 50 evaluable patients were to be recruited to test the null hypothesis that 10% or less patients get a response (p ≤ 0.10) Initially, 15 patients were to be included in a first stage. If one confirmed response occurred in the first 15 evaluable patients, recruitment had to continue up to 25 evaluable patients. Two of the first 15 patients had confirmed partial response (PR) to lurbinectedin treatment and, therefore, recruitment continued. Due to the signs of activity also observed in combination with doxorubicin [Descriptive statistics were used. Non-continuous variables are described in frequency tables using counts and percentages. Continuous variables are described by median, minimum and maximum. Binomial exact estimates and its 95% confidence interval (CI) were calculated for the evaluation of the main endpoint (ORR). The Kaplan-Meier method was used to analyze DoR, PFS and OS. For the translational sub-study analysis, the correlation between mutational status and OS or PFS was evaluated by a Cox regression analysis and Kaplan-Meier curves represented. SAS and R software were used to generate statistical outputs.