What is HLX43 studying for advanced lung cancer?

HLX43 is being studied in combination with Serplulimab to evaluate the right dose, safety, and effectiveness in patients with advanced lung cancer who have had prior immunotherapy and chemotherapy. Researchers aim to understand how these treatments work together to manage the disease. The study is sponsored by Shanghai Henlius Biotech.

Who may be eligible for this advanced lung cancer clinical trial?

Adults aged 18 to 75 with advanced non-small cell lung cancer without actionable gene alterations or small cell lung cancer may be eligible. Participants must have received prior platinum-based chemotherapy combined with anti-PD-1 or anti-PD-L1 therapy, have good performance status, and be willing to provide tumor tissue samples. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced lung cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID07253142

Phase II Study of HLX43 Combined With Serplulimab to Treat Advanced Lung Cancer after Prior Immunotherapy and Chemotherapy

Led by Shanghai Henlius Biotech · Updated on 2026-07-21

120

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the appropriate dose and the safety, tolerability, and effectiveness of HLX43 combined with Serplulimab in patients with advanced lung cancer. This phase II randomized, open-label study focuses on patients with advanced non-small cell lung cancer NSCLC without actionable gene alterations and small cell lung cancer SCLC who have previously received immunotherapy and platinum-based chemotherapy. The aim is to better understand how these treatments work together in this patient group. Participants are randomly assigned to receive one of two doses of HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, along with a fixed dose of Serplulimab, an anti-PD-1 antibody. Both medications are given by intravenous infusion every three weeks. Those who tolerate the treatment well and have controlled disease will continue receiving the combination every three weeks until disease progression, new anti-cancer therapy is started, intolerable side effects occur, death, or withdrawal of consent. During the study, participants will have regular assessments including tumor measurements according to RECIST 1.1 criteria, laboratory tests, and safety monitoring for adverse events. The main outcome measured is the overall response rate within 24 weeks, with additional measurements including progression-free survival up to 12 months and overall survival up to approximately 18 months. Follow-up for safety will continue up to 90 days after the last dose. The total duration of participation varies based on treatment response and tolerability.

CONDITIONS

Brief Title

A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Voluntarily agree to participate and complete study requirements
Age between 18 and 75 years
Confirmed locally advanced or metastatic NSCLC without actionable gene alteration or confirmed SCLC with disease progression or recurrence
Have received platinum-based chemotherapy combined with anti-PD-1/L1 antibodies as prior first-line or sequential treatment with no more than second- or third-line treatment
At least one measurable lesion within 4 weeks prior to randomization per RECIST 1.1 criteria
Agree to provide archived tumor tissue or undergo biopsy for PD-L1 testing
Meet specified treatment intervals from prior therapies before first study drug administration
ECOG performance status score of 0-1 within one week prior to randomization
Expected survival time more than 3 months
Laboratory tests confirming adequate organ function prior to first administration
Agree to use effective contraception during and for 6 months after the trial; negative pregnancy test for women of childbearing potential

You will not qualify if you...

Mixed SCLC, mixed NSCLC, or sarcomatoid carcinoma components confirmed by histology or cytology
Tumor invasion of major blood vessels or important organs, or risk of esophago-tracheal or esophagopleural fistula
Previous therapy targeting topoisomerase I including chemotherapy or ADC drugs
Radical radiotherapy within 3 months prior to first dose
History of second malignancy within 2 years except certain early-stage cancers
History of adverse events causing permanent discontinuation of immunotherapy or grade 2 or higher immune-related pneumonitis or myocarditis
Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
Active or symptomatic central nervous system metastases or meningitis carcinomatosa
Severe lung impairment or pulmonary diseases interfering with drug toxicity management
Poorly controlled cardiovascular or cerebrovascular diseases
Active systemic infections needing intravenous antibiotics within 2 weeks prior to randomization
Use of moderate or strong CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization
Systemic corticosteroids or immunosuppressive therapy within 2 weeks prior to randomization
Known active or suspected autoimmune diseases except controlled hypothyroidism or type 1 diabetes
Live or attenuated vaccines within 4 weeks prior to randomization
Known allergies to monoclonal antibodies or investigational drug components
Active pulmonary tuberculosis
History of immunodeficiency diseases including HIV or organ transplantation
Active HBV or HCV infection or co-infection
Pregnant or lactating women
History of psychiatric drug, substance abuse, or alcoholism
Investigator judgment deeming unsuitability for trial participation

Research Team

Yongqing Lin

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Phase II Study of HLX43 Combined With Serplulimab to Treat Advanced Lung Cancer after Prior Immunotherapy and Chemotherapy

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria