Figure 1. CONSORT Diagram.

Data cutoff date: October 4, 2018. bTMB indicates blood tumor mutational burden; mut/Mb, mutations per megabase; PD-L1, programmed cell death ligand 1; TC, tumor cell; tTMB, tissue tumor mutational burden.

^aScreening consent received for PD-L1 status.

^bOnly applicable for patients completing study treatment before implementation of clinical study protocol amendment, which allowed patients to continue receiving immunotherapy until disease progression, whereas previously a maximum of 12 months was allowed.

^cReason for discontinuation applies to the latest component discontinued.

^dIntention-to-treat population includes all randomized patients.

^eAs-treated population includes all patients who received at least 1 dose of study treatment.