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Evaluation of HLX10 Combined with Chemotherapy and Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized, Double-Blind Study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Limited-Stage Small Cell Lung Cancer (LS-SCLC). The study is investigating the effects of a new treatment called HLX10, which is a recombinant humanized anti-PD-1 monoclonal antibody. This treatment will be tested in combination with chemotherapy drugs, specifically carboplatin or cisplatin and etoposide, along with radiotherapy. The purpose of the study is to evaluate how effective and safe HLX10 is when used with these other treatments in patients with LS-SCLC.

Participants in the study will receive either the HLX10 treatment or a placebo, alongside the standard chemotherapy and radiotherapy. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the HLX10 or the placebo. This helps ensure that the results are unbiased. The study will take place over a period of time, with regular monitoring to assess the treatment's impact on the cancer and any side effects experienced by the participants.

The main goal is to see if the combination of HLX10 with chemotherapy and radiotherapy can improve overall survival rates for patients with LS-SCLC. Secondary goals include measuring progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse, and the objective response rate, which is the proportion of patients whose cancer shrinks or disappears after treatment. The study will also monitor the quality of life of participants and any adverse events that occur during the trial.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the study treatment

    After joining the study, you begin treatment for limited-stage small cell lung cancer (a fast-growing type of lung cancer that has not spread widely).

    You are assigned in a random way to receive either serplulimab or hlx10 placebo. A placebo is a treatment that looks like the study medicine but does not contain the active drug.

    The study is double-blind, which means that you and the study team do not know which study treatment you receive.

    Serplulimab is given as an intravenous infusion, which means it is put directly into a vein. The dose is 300 mg each time. The exact frequency and duration of this medicine are not stated in the source data.

    hlx10 placebo is given in the same study setting as the active study medicine. The exact dose, frequency, and duration are not stated in the source data.

  2. Step 2

    Chemotherapy and radiotherapy period

    You receive the study treatment together with chemotherapy and concurrent radiotherapy.

    Chemotherapy means cancer medicine. The chemotherapy medicines used are carboplatin, cisplatin, and etoposide.

    These medicines are given as part of the treatment plan during the study. The exact dose, frequency, and duration of the chemotherapy are not stated in the source data.

    Radiotherapy means treatment with radiation aimed at the cancer area. It is given at the same time as the chemotherapy, as stated by the term concurrent radiotherapy.

    The exact dose, frequency, and duration of the radiotherapy are not stated in the source data.

  3. Step 3

    Study assessments during treatment

    During the study, you have checks to see how the cancer is responding and how safe the treatment is.

    These checks include overall survival (how long you live during the study) and progression-free survival (the length of time before the cancer gets worse).

    The cancer response is measured using RECIST v1.1, which is a standard way to measure tumor changes on scans.

    The study also checks for side effects, including serious side effects.

    You may have blood tests, urine tests, thyroid function tests (tests that check how the thyroid gland is working), and cardiac function tests (tests that check how the heart is working).

    You may also have a 12-lead electrocardiogram (12-lead ecg), which is a test that records the heart's electrical activity, along with vital signs and a physical examination.

    The study may also assess your quality of life.

    The study may measure the amount of hlx10 in your blood, and it may check for antibodies against hlx10, including neutralizing antibodies (antibodies that can block the medicine from working).

    The study may also look at whether pd-l1 expression in tumor tissue is related to how well the treatment works. pd-l1 is a marker found in some tumor cells.

  4. Step 4

    End of study follow-up

    The study continues until the planned end of the trial period.

    The estimated study period runs from 2023-07-31 to 2027-07-19.

Who can join the trial?

16 criteria

  • The patient must voluntarily agree to join the study, understand the study, sign the informed consent form (ICF), and be willing and able to follow all study procedures.
  • The patient must be a man or woman aged 18 years or older when signing the informed consent form.
  • The patient must have small cell lung cancer confirmed by tissue testing, which means the diagnosis was made by examining a sample under a microscope.
  • The patient must have limited-stage small cell lung cancer, meaning stage I to III according to the AJCC 8th edition cancer staging system, and the cancer must be able to be safely treated with curative radiation doses (radiation doses intended to try to remove or control the cancer).
  • The patient must have at least one measurable tumor lesion, which means one tumor area that can be measured by the study doctor using standard imaging rules.
  • The patient must provide tumor tissue for testing of PD-L1 expression, which is a protein found on some cancer cells. The test must allow the tumor to be classified as PD-L1 negative, PD-L1 positive, or not evaluable if the result cannot be assessed.
  • The patient must have an ECOG performance status of 0 or 1, meaning they are fully active or have only slight restriction in daily activities.
  • The patient must be expected to live at least 6 months.
  • The patient must have good organ and bone marrow function, meaning blood-forming ability and the function of the heart, liver, and kidneys must not have serious problems, and there must be no immunodeficiency (a weak immune system) within 7 days before randomization.
  • Any previous non-systemic anti-cancer treatment must have been finished at least 2 weeks before starting the study drug, and any side effects from that treatment must have improved to grade 1 or lower on the CTCAE 5.0 scale, except for hair loss, which may still be grade 2.
  • If the patient is female, she must meet one of these conditions: menopause (no menstrual periods for at least 1 year with no other confirmed cause), surgical sterilization (for example, removal of the ovaries and/or uterus), or be able to become pregnant but have a negative pregnancy test in blood or urine within 7 days before randomization.
  • If the patient is female and able to become pregnant, she must agree to use a highly effective contraceptive method with less than 1% yearly failure rate, or remain abstinent (avoid heterosexual intercourse) from signing the informed consent form until at least 6 months after the last dose of the study drug.
  • Examples of highly effective contraception include bilateral tubal ligation (blocking both fallopian tubes), male sterilization of a partner, correct use of hormonal contraceptives that stop ovulation, hormone-releasing intrauterine devices or copper intrauterine devices, and condoms.
  • If the patient is female and able to become pregnant, she must not be breastfeeding.
  • If the patient is male, he must agree to remain abstinent or use condoms if his partner is pregnant or could become pregnant, during study treatment and for at least 6 months after the last dose of the study drug, to avoid exposing the embryo to the drug.
  • Periodic abstinence methods, such as tracking the calendar, ovulation timing, basal body temperature, or the post-ovulation phase, and withdrawal (external ejaculation) are not allowed as contraception methods for male patients in this study.

Who cannot join the trial?

28 criteria

  • Patients whose small cell lung cancer is a mixed type confirmed by tissue or cell testing.
  • Patients with peripheral neuropathy of grade 2 or higher. Peripheral neuropathy means nerve damage that can cause numbness, pain, or weakness, usually in the hands or feet.
  • Patients with HIV infection or a positive HIV antibody test.
  • Patients with active pulmonary tuberculosis, which is an active infection in the lungs caused by tuberculosis germs.
  • Patients with current or past interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe lung function problems that could make it hard to detect or manage possible lung side effects from the study treatment.
  • Patients with hepatitis B or hepatitis C infection, including certain positive blood test combinations that show active infection. Patients with hepatitis B that is stable on antiviral treatment and has low virus levels may still be allowed.
  • Patients with known active autoimmune disease or suspected autoimmune disease. Autoimmune disease means the immune system attacks the body’s own tissues. Patients whose autoimmune disease is stable and does not need systemic immunosuppressant medicine may still be allowed.
  • Patients who received a live vaccine within 28 days before the first study treatment. A live vaccine contains weakened germs that can still multiply. Inactivated flu vaccines are allowed, but nasal live flu vaccine is not allowed.
  • Patients who need systemic corticosteroids in doses higher than 10 mg/day of prednisone, or other immunosuppressive drugs, within 14 days before the first dose or during the study. Topical or inhaled steroids, and low-dose prednisone for hormone replacement, may be allowed in some cases.
  • Patients with any active infection that needs treatment with medicines that fight infection within 14 days before the study treatment starts.
  • Patients who had major surgery within 28 days before the first study dose. Major surgery means an operation that needs at least 3 weeks of recovery before study treatment can begin.
  • Patients who are fit for surgery. If a patient is suitable for surgery but refuses it, they may still be included.
  • Patients who have already received other immune checkpoint medicines, such as drugs against PD-1, PD-L1, or CTLA4. These are medicines that affect the immune system.
  • Patients taking part in another interventional clinical study, or who finished treatment in another such study less than 28 days ago. Interventional means the study gives a treatment or procedure.
  • Patients with a known history of severe allergy to any monoclonal antibody. A monoclonal antibody is a lab-made protein used as a medicine.
  • Patients with known anaphylaxis to carboplatin, cisplatin, or etoposide. Anaphylaxis is a severe, sudden allergic reaction.
  • Pregnant or breastfeeding women.
  • Patients with a known history of psychotropic substance abuse or drug abuse. Psychotropic substances are medicines or drugs that affect mood, thinking, or behavior.
  • Patients who, in the investigator’s judgment, have other factors that could cause them to stop the study early.
  • Patients expected to need surgical resection during the study. Surgical resection means an operation to remove part of the tumor or tissue.
  • Patients whose main tumor or lymph nodes are too large for the planned radiotherapy. Radiotherapy means treatment with radiation.
  • Patients who have already received systemic anti-tumor treatment for small cell lung cancer, including radiotherapy, chemotherapy, or immunotherapy. Systemic treatment means treatment that affects the whole body.
  • Patients with another active cancer within the past 5 years or at the same time, except for certain cured localized cancers such as some skin, bladder, prostate, cervical, or breast cancers in situ. In situ means very early cancer that has not spread.
  • Patients who are preparing for, or have already received, an organ transplant or bone marrow transplant. Bone marrow is the soft tissue inside bones that makes blood cells.
  • Patients with pleural effusion, pericardial effusion, or ascites that need medical treatment. These are fluid build-ups around the lungs, around the heart, or in the abdomen.
  • Patients who had a myocardial infarction (heart attack) or poorly controlled arrhythmia within 6 months before the first dose. Arrhythmia means an abnormal heart rhythm. This also includes a QTc interval of 470 ms or higher on the heart tracing test. QTc is a measure of how the heart resets between beats.
  • Patients with NYHA class III or IV heart failure, or a left ventricular ejection fraction below 50%. Heart failure means the heart does not pump well enough. Left ventricular ejection fraction is the percentage of blood the main pumping chamber sends out with each beat.
  • Patients with uncontrolled or symptoms from high calcium in the blood, including ionized calcium above 1.5 mmol/L, calcium above 12 mg/dL, or corrected calcium above the upper normal limit.
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Investigated drugs

Serplulimab is the study medicine being tested in this trial. It is given through a vein as an infusion. In this study, it is used together with chemotherapy and radiation therapy to see whether it can help shrink the cancer and improve treatment results for people with limited-stage small cell lung cancer.

Chemotherapy with carboplatin or cisplatin plus etoposide is part of the treatment plan in this trial. These medicines are standard cancer drugs that work by killing cancer cells or stopping them from growing. They are given along with radiation therapy to treat the lung cancer.

Radiotherapy is also part of the trial treatment. This uses high-energy radiation aimed at the cancer area to damage and destroy cancer cells. It is given at the same time as the chemotherapy, and the study is checking how well the full treatment combination works.

What is already known about the treatment

HLX10 placebo - This is an inactive solution given by the same route as the study drug, usually by intravenous infusion, so that neither the patient nor the study team can easily tell who is receiving the real medicine. It has no active substance, no direct effect on the body, and is used in medical research to compare against the test treatment and help show whether the study drug truly works. Because it is a placebo, it is not used to treat any disease and does not belong to a pharmacological drug class. Serplulimab - Serplulimab is given by intravenous infusion as a concentrated solution for infusion, meaning it is delivered directly into a vein by a healthcare professional. It is a newer cancer medicine and a monoclonal antibody that is still being studied and used in some countries for certain cancers, especially where the immune system needs help fighting the tumor. Its main use is in cancer treatment, and it works by blocking the PD-1 protein on immune cells, which helps release the “brakes” on the immune response so the body can attack cancer cells more strongly. It is classified as an immune checkpoint inhibitor and an anti-PD-1 monoclonal antibody.

Investigated diseases

Limited-stage small cell lung cancer - A fast-growing type of lung cancer that starts in the small cells of the airways. It is called limited-stage when the cancer is still confined to one side of the chest and nearby lymph nodes. It often grows and spreads more quickly than non-small cell lung cancer. As it progresses, it can spread within the chest and later to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515047-31-00Protocol codeHLX10-020-SCLC302Estimated enrolment500 patientsSponsorShanghai Henlius Biotech Inc.

sourced from the EU Clinical Trials Register and site verification

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