NCT06907615

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)

Detailed description

This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with advanced non-small cell lung cancer (NSCLC). In this study, eligible subjects will be randomized at 1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HLX43 DOSE 1 (2.0 mg/kg)	Dose 1; 2.0 mg/kg; 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 (2.5 mg/kg)	Dose 2; 2.5 mg/kg; 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: 2025-06-09
• Primary completion: 2028-04-20
• Completion: 2028-06-04
• First posted: 2025-04-02
• Last updated: 2025-08-17

Locations

2 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study