This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 in combination with Serplulimab and chemotherapy in the treatment of patients with Non-small cell lung cancer.~The study is composed of the Part 1 (dose escalation) and Part 2 (dose expansion). In Part 1, a 3 + 3 dose escalation design will be used. Patients will receive HLX26 (800mg or 1600mg) combined with fixed dose (300mg) Serplulimab and chemotherapy intravenously every 3 weeks. Observation period of DLT lasts for 3 weeks after the first administration of HLX26. Safety review committee (SRC) will responsible for the safety of combination treatment. After confirmation of the safety, the efficacy of HLX26 (800mg or 1600mg) combined with Serplulimab and chemotherapy will be evaluated in Part 2. Eligible subjects will be enrolled in the HLX26 800mg group and HLX26 1600mg group in sequence. The chemotherapy will be decided by investigator per patients' pathological type. nsqNSCLC patients will receive pemetrexed and carboplatin as chemotherapy and sqNSCLC patients will receive nab-paclitaxel and carboplatin. About 60 patients will be enrolled in total.
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients