Primary Objective: Phase 2 To compare the ORR in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25mg + PCT vs. PCT (Arms A vs. C) Secondary Objectives: To compare the PFS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25 mg + PCT vs. PCT (Arms A vs. C) To compare the ORR in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C) To compare the PFS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C) To compare the OS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25 mg + PCT vs. PCT (Arms A vs. C) To compare the OS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C) To assess the safety of STK-012 therapy in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT vs. PCT To assess the immunogenicity of STK-012 in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT To assess the PK of STK-012 in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT
STK-012-101: A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications