CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 706 target
Drug / intervention
HLX43 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07459751
NCT07459751Phase 2RecruitingOn Track
CompareCT.gov

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)

Shanghai Henlius Biotech·interventional·Posted Mar 10, 2026·Updated Jun 1, 2026

In Brief

A Phase 2 clinical trial evaluating HLX43, HLX43+HLX07, and 1 other intervention for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer. Currently recruiting, targeting 706 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced or Metastatic Squamous Non-Small Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2027202820292030
First PostedMar 10, 2026
Enrollment StartMay 27, 2026
Primary CompletionJan 15, 2030
TodayJul 1, 2026
Enrollment to primary: 3.6 yearsPosted 4 months agoPrimary completion in 3.5 years

Arms & Interventions

HLX43experimental

HLX43 intravenously on Day 1 of each 3-week cycle

Drug: HLX43
HLX43 + HLX07experimental

HLX43 and HLX07 intravenously on Day 1 of each 3-week cycle;

Drug: HLX43+HLX07
docetaxelactive_comparator

Docetaxel intravenously on Day 1 of each 3-week cycle

Drug: Docetaxel

Interventions

HLX43drug

Anti-PD-L1 ADC

HLX43+HLX07drug

Anti-PD-L1 ADC + Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection

Docetaxeldrug

Active Comparator