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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2026-03-10

No results posted yet for this study

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

DRUG

HLX43

Anti-PD-L1 ADC

DRUG

HLX43+HLX07

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

DRUG

Docetaxel

Active Comparator

Sponsors & Collaborators

Principal Investigators

  • Jie Wang · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-09
Primary Completion
2030-01-15
Completion
2030-01-15
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07459751 on ClinicalTrials.gov