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A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC

StatusRecruiting
PhasePhase 2
Started2026-01-20
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2026 (before its estimated July 10, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-06-02
Study Status, Study Description, Arms and Interventions v3
Study description+5 characters
[...] xed dosage via intravenous infusion every 3 weeks (Q3W) for 3 or 4 cycle.
2026-01-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-12-07
Study Identification, Study Status, Arms and Interventions v1
InterventionsHLX43 DOSE 1 (Drug), HLX43 DOSE 2 (Drug)→HLX43 DOSE 1 (Drug), HLX43 DOSE 2 (Drug), Serplulimab (Drug)
Study title-18 characters
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Combination With+ Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC
2025-11-26
Original filing
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)
Trial Details
NCT Number NCT07269782
Lead Sponsor Shanghai Henlius Biotech
Conditions Non Small Cell Lung Cancer
Enrollment 60 participants
Start Date 2026-01-20
Primary Completion 2026-07-10 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-04