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

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…

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

NOT_YET_RECRUITING

phase

PHASE2, PHASE3

study type

INTERVENTIONAL

enrollment

1438

sponsor

Shanghai Henlius Biotech

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

start date

2026-11-30

start date type

ESTIMATED

primary completion date

2030-12-30

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters