drugset / Trial / 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

NCT07459751

Phase 2/3 Recruiting 706 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-27
Primary completion
2030-01-15
Completion
2030-01-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule Intravenous
Subject HLX43 Other / unclassified Intravenous
Subject PIMURUTAMAB Monoclonal antibody Intravenous