NCT07253142

A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Humanized Anti-PD-1 Monoclonal Antibody Injection) in Advanced Stage Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer.

Detailed description

This study is a randomized, open-label phase II clinical study to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 in combination with serplulimab in patients with advanced lung cancer who have received immunotherapy and platinum-contained chemotherapy, including actionable gene alteration (AGA) negative non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). In this study, eligible subjects will be randomized at 1:1 ratio, and the patients will be administered with HLX43 at one of the two dose levels plus serplulimab at a fixed dosage via intravenous infusion every 3 weeks (Q3W).

Conditions

• Non Small Cell Lung Cancer
• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HLX43 dose 1	HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
DRUG	HLX43 dose 2	HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

Timeline

• Start date: 2026-01-14
• Primary completion: 2027-06-18
• Completion: 2028-06-19
• First posted: 2025-11-28
• Last updated: 2025-12-02

Locations

1 site across 1 country: China