Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC

This was a Phase 1/2, open-label, multicenter, 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors in subjects with NSCLC. Up to 56 subjects were planned for enrollment from up to 8 clinical sites in 2 arms: Arm A: mRNA Vaccine \[BI 1361849 (formerly CV9202)\] + anti-PD-L1 antibody \[durvalumab\] Arm B: mRNA Vaccine \[BI 1361849\] + anti-PD-L1 \[durvalumab\] + anti-CTLA-4 antibody \[tremelimumab\] Subjects must have had histologically confirmed metastatic NSCLC. For subjects with known EGFR or ALK/ROS-1 mutations, prior therapy must have included an EGFR tyrosine kinase inhibitor or ALK/ROS-1 inhibitor, respectively. Subjects may have had 1 prior line of anti-PD-1/PD-L1 therapy and must not have had progression at or before 12 weeks after start of the prior anti-PD-1/PD-L1 treatment.