NCT07459751

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 671 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multi-center, global phase II/III clinical study to evaluate the efficacy and safety of HLX43 monotherapy or HLX43 in combination with HLX07 vs. docetaxel in the treatment of advanced squamous NSCLC after failure of first-line treatment.

Conditions

• Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HLX43	Anti-PD-L1 ADC
DRUG	HLX43+HLX07	Anti-PD-L1 ADC + Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection
DRUG	Docetaxel	Active Comparator

Timeline

• Start date: 2026-04-09
• Primary completion: 2030-01-15
• Completion: 2030-01-15
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study