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A study to evaluate the safety and effectiveness of HLX43 in patients with advanced non-small cell lung cancer

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What is this study about?

This study focuses on Advanced Non-Small Cell Lung Cancer, which is a common type of lung cancer that has spread or grown significantly. The research aims to evaluate the efficacy and safety of a new treatment called HLX43. This medication is an antibody-drug conjugate, a type of drug designed to deliver a potent medicine directly to cancer cells using a specialized targeting system. The treatment will be given through intravenous administration, meaning it is delivered into a vein using a liquid solution.

The purpose of the study is to determine how well this new drug works and to monitor its safety in people with this condition. During the study, participants will receive the medication, and their health will be closely monitored. This includes checking for any side effects and observing how the cancer responds to the treatment over time.

Who Can Join the Study?

  • You must be 18 years of age or older at the time you sign the consent form.
  • You must have advanced non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread or is more advanced, and it must not be suitable for complete removal by surgery or standard radiation and chemotherapy.
  • You must have a measurable lesion, which means a tumor that can be clearly seen and measured on medical imaging like a scan, located in an area not previously treated with radiation (unless it is the only option).
  • You must agree to provide tumor tissue from a previous surgery or biopsy, or undergo a new biopsy (a procedure to take a small sample of tissue) to test for PD-L1 expression (a protein on cancer cells used to help determine treatment).
  • If you are a person of childbearing age, you must agree to use highly effective contraception (methods to prevent pregnancy) during the study and for at least 8 months after the last dose, and you must have a negative pregnancy test within 7 days before joining.
  • You must fully understand the study, its processes, and possible adverse reactions (unwanted or harmful side effects), and you must sign the informed consent form (a document that explains the study details before you agree to join).
  • You must have failed at least one previous standard treatment, which must include platinum-based chemotherapy (a common type of cancer medicine using platinum) and anti-PD-(L)1 antibody (a type of immunotherapy that helps the immune system fight cancer).
  • Depending on your specific cancer type, you must either have no actionable genomic alterations (specific genetic changes in cancer cells that can be targeted by drugs) or have confirmed actionable genomic alterations that were previously treated with targeted therapy (medicines designed to attack specific parts of cancer cells).
  • There must be a specific amount of time passed since your last treatments: at least 3 weeks since major surgery, radiation, or chemotherapy; at least 2 weeks since hormone or small molecular targeted therapy; and at least 1 week since traditional Chinese medicine or minor surgery.
  • Any adverse events (side effects) from previous treatments must have recovered to Grade 1 or less, meaning they are very mild or non-existent.
  • You must have an ECOG Performance Status of 0 or 1, which is a scale used to measure how well a person can perform daily activities while having a disease.
  • You must have a life expectancy of more than 3 months.
  • Your organ functions (how well your organs like the liver or kidneys work) must be healthy according to laboratory tests, and you must not have received blood transfusions or certain blood-boosting medications in the 14 days before the first dose.

Who Cannot Join the Study?

  • You cannot participate if your tumor is confirmed to be a different type, such as small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma, which are specific ways lung cancer cells can look and behave under a microscope.
  • You cannot participate if you have an active systemic infection (an infection spreading through your whole body) that required intravenous antibiotics (medicine given directly into a vein) in the last 2 weeks.
  • You cannot participate if you have used certain liver enzymes inhibitors or inducers (medicines that change how your body processes other drugs) within the last 2 weeks.
  • You cannot participate if you have used systemic corticosteroids (strong medicines that reduce inflammation and suppress the immune system) or other immunosuppressants (drugs that lower your body’s ability to fight infection) in the last 2 weeks, unless they were applied locally like creams or inhaled.
  • You cannot participate if you have a known active or suspected autoimmune disease (a condition where the immune system mistakenly attacks the body’s own healthy cells), though some controlled conditions like certain thyroid issues or type 1 diabetes are allowed.
  • You cannot participate if you have received a live or live attenuated vaccine (vaccines that use a weakened version of a germ) in the last 4 weeks.
  • You cannot participate if you have a known allergy or anaphylaxis (a severe, life-threatening allergic reaction) to monoclonal antibodies (lab-made proteins that target specific parts of the immune system) or any part of the study drug.
  • You cannot participate if you have active tuberculosis (a serious bacterial infection that usually affects the lungs).
  • You cannot participate if you have a history of immunodeficiency (a weakened immune system), such as HIV, other immune disorders, or a history of organ transplantation.
  • You cannot participate if you have an active HBV (Hepatitis B) or HCV (Hepatitis C) infection, unless the virus levels are very low and meet specific testing requirements.
  • You cannot participate if you are pregnant or lactating (breastfeeding).
  • You cannot participate if you have previously used medicines that target topoisomerase I, which includes certain types of chemotherapy (cancer-fighting drugs) or ADCs (drugs that combine chemotherapy with antibodies to target cancer cells).
  • You cannot participate if the doctor decides you are not suitable due to other health or laboratory abnormalities (unusual results from blood or urine tests).
  • You cannot participate if you had radical radiation therapy (intensive radiation treatment to destroy cancer) within the 3 months before your first dose.
  • You cannot participate if you had a second malignancy (a new, different type of cancer) within the last 2 years, unless it was an early-stage cancer that was fully treated.
  • You cannot participate if you had to stop immunotherapy (treatment that helps your immune system fight cancer) due to side effects, or if you had pneumonitis (inflammation of lung tissue) or myocarditis (inflammation of the heart muscle) during previous immunotherapy.
  • You cannot participate if you have uncontrollable fluid buildup in the chest (pleural effusion), around the heart (pericardial effusion), or in the abdomen (ascites) that requires constant draining.
  • You cannot participate if you have spinal cord compression (pressure on the spinal cord) or metastases (cancer that has spread) to the central nervous system (the brain and spinal cord).
  • You cannot participate if you have significant pulmonary impairment (lung problems) from conditions like asthma, COPD (chronic obstructive pulmonary disease), interstitial pneumonia (scarring of the lung tissue), or pneumonectomy (surgical removal of a lung).
  • You cannot participate if you have poorly controlled heart or brain-related issues, such as heart failure, unstable angina (chest pain), myocardial infarction (heart attack), cerebrovascular accident (stroke), arrhythmia (irregular heartbeat), or high hypertension (high blood pressure).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Comite Entreprise Paul Papin Angers France
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Onco Clinic Consult S.A. Craiova Romania
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Lucus Augusti Lugo Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Medicover S.R.L. Bucharest Romania
Mruk-Med I Sp. z o.o. Rzeszow Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
AORN San Giuseppe Moscati Avellino Avellino Italy
Spitalul Clinic Coltea Bucharest Romania
Igoedejv Rodqvuuus Pvj Lv Strvxy Duc Toxtol Dxyn Ahpktgo Ikzt Swxopm Meldola Italy
Aodjbuy Obliadgemhe Uumdxbveyrjqw Sztvnf Siena Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
03.04.2026
Italy Italy
Recruiting
03.04.2026
Poland Poland
Recruiting
03.04.2026
Romania Romania
Recruiting
03.04.2026
Spain Spain
Recruiting
03.04.2026

Trial locations

Investigated drugs:

HLX43 is an experimental drug being tested to see if it can help treat advanced non-small cell lung cancer. It belongs to a class of drugs known as antibody-drug conjugates, which are designed to deliver a powerful medicine directly to cancer cells to help fight the disease.

Non-small cell lung cancer – This type of lung cancer begins in the cells that line the airways of the lungs. It is characterized by the uncontrolled growth of abnormal cells that can form tumors. As the disease progresses, these cells may spread from the original site to other parts of the body. The condition often involves different types of cells, such as adenocarcinoma or squamous cell carcinoma. The progression can vary depending on how the cells behave and where they spread.

Trial ID:
2025-523803-31-00
Protocol code:
HLX43-NSCLC201
NCT ID:
NCT06907615
Trial Phase:
Therapeutic exploratory (Phase II)

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