Actively Recruiting
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC
Led by Shanghai Henlius Biotech · Updated on 2026-01-22
60
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily agree to participate by signing informed consent
- Aged 18 to 75 years, male or female
- Have confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Diagnosed with stage II to IIIB NSCLC without specific gene alterations (EGFR and ALK negative for non-squamous NSCLC)
- Eligible for complete surgical removal of tumor after neoadjuvant therapy
- Have at least one measurable tumor lesion within 4 weeks before randomization
- Agree to provide tumor tissue samples for PD-L1 testing or undergo biopsy
- At least 3 weeks from major surgery or device treatment, 1 week from minor surgery, and recovered from treatment side effects to mild level
- ECOG performance status score of 0-1 within one week before randomization
- Life expectancy greater than 3 months
- Adequate organ function confirmed by lab tests within one week before randomization
- Agree to use effective contraception during study and for 6 months after last dose; females of childbearing age must have negative pregnancy test within 7 days before enrollment
You will not qualify if you...
- Tumors containing small cell lung cancer or neuroendocrine carcinoma components
- Any prior systemic or local anti-cancer treatment for NSCLC
- History of other cancers within 2 years except certain early-stage treated cancers
- Previous severe immune-related side effects or pneumonitis/myocarditis grade 2 or higher
- Significant lung diseases or autoimmune/connective tissue diseases affecting lungs
- Uncontrolled heart or blood vessel conditions or recent heart attack or stroke
- Active infections requiring intravenous antibiotics within 2 weeks before randomization
- Previous treatment with immune checkpoint antibodies
- Use of certain enzyme inhibitors or corticosteroids recently
- Known active or suspected autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Received live vaccines within 4 weeks before randomization
- Allergies to study drug components
- Active tuberculosis
- History of immunodeficiency or organ transplantation
- Active hepatitis B or C infection or co-infection
- Pregnant or breastfeeding women
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
Research Team
C
Chang Chen, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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