# 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

Source: https://onco.cc/trials/nct07459751/  
OnCo record `nct07459751` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial testing HLX43 in non-small-cell lung cancer, now recruiting.

## Summary

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 is a phase 2/3 interventional study registered as NCT07459751, led by Shanghai Henlius Biotech, and recruiting on the registry. Official title: A Randomised, Open-Label, Multi-centre, 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). Planned enrolment is 706 participants (estimated). The study started in 2026-05-27 and primary completion is expected in 2030-01-15. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT07459751
- Phase: 2/3
- Setting: 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)
- Sponsor: Shanghai Henlius Biotech
- Enrolled: 706

## Sources

- ClinicalTrials.gov NCT07459751: https://clinicaltrials.gov/study/NCT07459751

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- drugs: [HLX43](https://onco.cc/drugs/hlx43/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)

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