Background:In the open-label, randomised, phase III RATIONALE-304 trial (NCT03663205), patients (pts) with locally advanced/metastatic nsq-NSCLC receiving TIS + CT experienced improved survival vs those receiving CT alone, with the magnitude of benefit being more pronounced in pts with tumour cell PD-L1 membrane expression 50% vs those with PD-L1 <50%, aligning with the general trend of programmed cell death protein-1 inhibitor efficacy increasing with PD-L1 expression.Methods: Adult pts with stage IIIB/IV nsq-NSCLC were randomised (2:1) to TIS + platinum-based CT + pemetrexed every 3 weeks or platinum-based CT + pemetrexed.The primary endpoint was progression-free survival (PFS) by independent review committee.Overall survival (OS) was a key secondary endpoint.Crossover from CT to TIS + CT was allowed upon independent review committee-confirmed disease progression.Genomic profiling and tumour mutational burden (TMB) analyses were performed on PD-L1-evaluable tumour tissue using next-generation DNA sequencing.Background: This study (AK104-IIT-018, NCT05816499) aimed to evaluate the safety and efficacy of cadonilimab (a PD-1/CTLA-4 bispecific antibody), anlotinib, and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced nonsmall cell lung cancer (NSCLC) without sensitizing EGFR/ALK/ROS1 mutations.
Baramidze et al. (Tue,) studied this question.