Trial objectives and endpoints
death, tumor
EVENT, TUMOR
The primary endpoint of the trial was progression-free survival rate at 6 months (24 weeks), assessed from date of registration to date of progression according to RECISTv1.1 or death from any cause. Secondary endpoints were progression-free survival rate at 6 months in patients with immune-related ILC, progression-free survival rate at 12 months, progression-free survival according to iRECIST, overall survival, ORR and safety. The clinical benefit rate comprised CR, PR and SD for at least 24 weeks. Progression-free survival was calculated from date of registration to date of progression according to RECIST1.1 or date of death, whichever occurred earlier. Overall survival was calculated from date of registration to date of death or last date of follow-up. Patients were censored in cases of no event at the last assessment before the data cutoff of 1 October 2021. Duration of response was calculated from the first date of an objective response to date of progression according to RECIST1.1. Translational endpoints were the assessment of the immunogenic effects of carboplatin on the tumor microenvironment and in the circulation using IHC, next-generation sequencing, flow cytometry, the additive effect of anti-PD-L1 on these changes and exploration of predictive biomarkers.