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

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07269782
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HLX43 DOSE 1 — DRUG
    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
  • HLX43 DOSE 2 — DRUG
    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
  • Serplulimab — DRUG
    Serplulimab Injection, Recombinant humanized anti PD 1 monoclonal antibody

Study Details

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)

Key Dates

Start date
Jan 20, 2026
Status verified
Jun 2026
Primary completion
Jul 10, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX43 DOSE 1 + Serplulimab
    Patients will receive the treatment once every 3 weeks (Q3W), for 3 or 4 cycles.
  • Experimental: HLX43 DOSE 2 + Serplulimab
    Patients will receive the treatment once every 3 weeks (Q3W), for 3 or 4 cycles.

Primary Outcome Measure

MPR [ Time Frame: At time of surgery ]

Central Contacts

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