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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

StatusRecruiting
PhasePhase 2/3
Started2026-05-27
View on ClinicalTrials.gov ↗

Amendment history

2026-05-28
Study Status, Contacts/Locations v2
Trial status changed: Enrolling by Invitation → Recruiting
Trial status changed: Not Yet Recruiting → Enrolling by Invitation
Study sitesdetails revised at 1 of 1 site
2026-05-27
Not Yet Recruiting→Enrolling by Invitation Study Status, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2026-04-09→confirmed 2026-05-27
Enrollment target671→706
Study sitescontacts updated at 1 of 1 site
2026-03-05
Original filing
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.
Trial Details
NCT Number NCT07459751
Lead Sponsor Shanghai Henlius Biotech
Conditions Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Enrollment 706 participants
Start Date 2026-05-27
Primary Completion 2030-01-15 (estimated)
Study Completion 2030-01-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-01