RecruitingPhase 2NCT07269782

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

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC


Sponsor

Shanghai Henlius Biotech

Enrollment

60 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — HLX43 (an anti-HER3 antibody) and serplulimab (an immunotherapy drug targeting PD-1) — as a pre-surgery (neoadjuvant) treatment for people with stage II–IIIB non-small cell lung cancer (NSCLC) that does not carry specific genetic mutations that would be better treated with targeted drugs. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed NSCLC at stage II to IIIB - Your tumor does not have actionable mutations (like EGFR or ALK changes) - You have not yet received any cancer treatment for this lung cancer - You and your surgeon agree that surgery aiming for complete removal of the cancer is possible - You have at least one measurable tumor on imaging - Your heart and major organ functions are within acceptable ranges **You may NOT be eligible if...** - Your cancer contains small cell lung cancer components - You have previously received chemotherapy, radiation, or immunotherapy for any lung cancer - You have significant heart disease, including recent heart attack or uncontrolled heart failure - You have active autoimmune disease, active infections, or HIV - You have active hepatitis B or C (controlled hepatitis B with very low viral load may be acceptable) - You have had a previous organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX43 DOSE 1

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.

DRUGHLX43 DOSE 2

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.

DRUGSerplulimab

Serplulimab Injection, Recombinant humanized anti PD 1 monoclonal antibody


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, China

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NCT07269782


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