A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Registry record from ClinicalTrials.gov (NCT07865910). This is a study registration, not published results. Lead sponsor: Shanghai Henlius Biotech. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 1438 participants (ESTIMATED). Conditions: NSCLC (Advanced Non-small Cell Lung Cancer). Interventions: DRUG: Investigational drug: HLX37 dose1, IV, Q3W; DRUG: PEMBROLIZUMAB (alone or when added to a regimen above); DRUG: Carboplatin (Investigator discretion); DRUG: Paclitaxel or Nab-Paclitaxel; DRUG: Pemetrexed (1); DRUG: Investigational drug: HLX37 dose2, IV, Q3W. Primary outcome measures: PFS assessed by BICR (Phase2&3) , From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months; ORR assessed by BICR (phse2) , From date of the first dose of study drug until the date of death from any cause, assessed up to 24months; OS (phase3) , From date of the first dose of study drug until the date of death from any cause, assessed up to 50 months. Brief summary: This is a Randomized, Double-Blind, Multicenter, Phase II/III Study to Evaluate HLX37 (Recombinant Human Anti-PD-L1 and Anti-VEGF Bispecific Antibody) in Combination with Chemotherapy Versus Pembrolizumab in Combination with Chemotherapy for First-Line Therapy of Advanced Non-Small Cell Lung Cancer.The first phase of this study is a Phase II trial, with Substudy A enrolling approximately 90 participants and Substudy B enrolling approximately 90 participants. Based on your disease pathology type, the investigator will determine which substudy you are enrolled in. Eligible participants will be randomly assigned to one of three treatment groups in a 1:1:1 ratio (similar to flipping a coin or drawing names from a hat), giving each participant an equal 1/3 chance of being assigned to any given group. Within each substudy, approximately one-third of participants will receive HLX37 at dose1combined with chemotherapy, one-third will receive HLX37 at dose2 combined with chemotherapy, and one-third will receive pembrolizumab at 200 mg combined with chemotherapy. All three treatment groups will have a treatment schedule of every three weeks (Q3W). The second phase of this study is a Phase III trial, with Substudy A enrolling approximately 820 participants and Substudy B enrolling approximately 618 participants. Again, based on your disease pathology type, the investigator will determine your enrollment into either substudy. Eligible participants will be randomly assigned to one of two treatment groups in a 1:1 ratio (similar to flipping a coin or drawing names from a hat), giving each participant an equal 1/2 chance of being assigned to either group. In each substudy, approximately half of the participants will receive HLX37 at dose selected combined with chemotherapy, and the other half will receive pembrolizumab at 200 mg combined with chemotherapy. Both treatment groups will follow a Q3W treatment schedule. Primary objective is to evaluate the efficacy of different doses of HLX37 in combination with chemotherapy vs. pembrolizumab in combination with chemotherapy as first-line therapy in participants with advanced non-small cell lung cancer (NSCLC). Secondary objectives includes: * To evaluate the safety of HLX37 in combination with chemotherapy vs. pembrolizumab in combination with chemotherapy as first-line therapy in participants with advanced NSCLC * To evaluate the pharmacokinetic (PK) profile of HLX37 * To evaluate the immunogenicity of HLX37 * To evaluate the relationship between PD-L1 expression in tumor tissues and efficacy