The study is divided into two parts. The first part is a phase II, single-arm study, which is planned to enroll 60 subjects. The second part is a phase III randomized, double-blind, placebo-controlled study. The study plans to enroll 314 subjects, who will be randomized in a 1:1 ratio to an experimental group of PM8002 in combination with chemotherapy (pemetrexed and carboplatin) and a control group of chemotherapy (pemetrexed and carboplatin).
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II/III study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.