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Study on Toripalimab and Tifcemalimab for Patients with Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy

Fast replyInvestigationalNo placebo
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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). This is a form of cancer that affects the lungs and is typically treated with a combination of chemotherapy and radiation therapy. The study is investigating the use of two medications, Toripalimab and Tifcemalimab, as potential treatments for patients who have not experienced disease progression after receiving standard treatments.

The purpose of the study is to evaluate the effectiveness of these medications when used as a follow-up treatment, also known as consolidation therapy, to help prevent the cancer from returning or worsening. Participants in the study will receive either Toripalimab alone, a combination of Toripalimab and Tifcemalimab, or a placebo. The study is designed to compare the outcomes of these different treatment approaches.

During the study, participants will receive the medications through an intravenous (IV) infusion, which means the medicine is given directly into a vein. The study will monitor participants over a period of time to assess their overall survival and how long they remain free from cancer progression. The trial aims to provide valuable information on whether these treatments can improve outcomes for patients with LS-SCLC.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide informed consent, agreeing to participate and comply with study requirements.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of limited-stage small cell lung cancer and ensuring no disease progression after previous treatments.

  3. Step 3

    Treatment allocation

    The patient will be randomly assigned to one of the treatment groups. This could involve receiving either toripalimab alone, toripalimab combined with tifcemalimab, or a placebo. The treatment is administered intravenously.

  4. Step 4

    Treatment administration

    The patient will receive the assigned treatment intravenously. The frequency and duration of administration will be determined by the study protocol and communicated to the patient.

  5. Step 5

    Regular monitoring

    Throughout the study, the patient will undergo regular monitoring to assess health status and treatment effects. This includes physical exams, blood tests, and imaging studies.

  6. Step 6

    Follow-up assessments

    The patient will participate in follow-up assessments to evaluate the treatment's impact on overall survival and disease progression. These assessments will be conducted by a blinded independent review committee.

  7. Step 7

    Completion of study

    Upon completing the study, the patient will have a final assessment to gather data on the treatment's long-term effects. The patient will be informed about the study's findings and any further steps if necessary.

Who can join the trial?

11 criteria

  • Must be a male or female who is at least 18 years old.
  • If you are a woman who can have children or a man with a partner who can have children, you must use a reliable form of birth control, like a birth control pill or condom, during the study and for at least 4 months after the last dose of the study medication.
  • You must agree to participate in the study, sign a consent form, and follow all study procedures.
  • You must have a confirmed diagnosis of limited-stage small cell lung cancer (LS-SCLC) that can be treated with radiation. If you have Stage I or II disease, you must not be able to have surgery or choose not to have it.
  • You must have completed a specific type of treatment called chemoradiotherapy (CRT), which includes 4 cycles of chemotherapy with drugs like carboplatin or cisplatin and etoposide, and a certain amount of radiation. You must start the study treatment within 42 days after finishing this treatment.
  • You must have shown a complete response, partial response, or stable disease after the CRT and must not have any disease progression before joining the study.
  • Prophylactic cranial irradiation (PCI), a type of radiation to the brain to prevent cancer spread, is allowed if your doctor thinks it's necessary. It can be done before or during the study.
  • You need to provide about 5 slides of tumor tissue for analysis. If you can't provide these samples, you may still join the study after discussing with the study team.
  • You must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, which means you are fully active or have some symptoms but can still do light work.
  • You must have a life expectancy of at least 12 weeks.
  • Your organs must be functioning well, which includes having enough blood cells, normal liver and kidney function, and normal blood clotting ability.

Who cannot join the trial?

10 criteria

  • Patients who have not completed **chemoradiotherapy (CRT)**. This is a treatment that combines chemotherapy and radiation therapy.
  • Patients whose **disease has progressed** after receiving CRT. This means the cancer has gotten worse or spread.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
  • Patients who have a history of other cancers, unless they have been in remission for a certain period.
  • Patients who have certain infections or diseases that could affect their immune system.
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Investigated drugs

  • Toripalimab

    is a medication used in this clinical trial as a consolidation therapy for patients with limited-stage small cell lung cancer. It is being tested to see if it can help improve survival rates and delay the progression of the disease after patients have received chemoradiotherapy.

  • Tifcemalimab (JS004/TAB004)

    is another medication involved in the trial. It is being combined with toripalimab to evaluate if the combination can provide better outcomes for patients with limited-stage small cell lung cancer. The study aims to determine if this combination can enhance overall survival and progression-free survival compared to other treatments.

What is already known about the treatment

  • Toripalimab

    Toripalimab is administered intravenously and is currently being studied in clinical trials as a potential treatment for limited-stage small cell lung cancer (LS-SCLC) in patients who have not shown disease progression after chemoradiotherapy. It is an investigational drug that is not yet widely approved for use outside of clinical trials. The main therapeutic indication is as a consolidation therapy to improve survival outcomes. Toripalimab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Tifcemalimab

    Tifcemalimab is also administered intravenously and is being evaluated in combination with toripalimab in clinical trials for patients with limited-stage small cell lung cancer who have completed chemoradiotherapy. This medication is still under investigation and not yet approved for general medical use. Its primary therapeutic use is to enhance the immune response against cancer cells. Tifcemalimab functions by targeting specific immune pathways to boost the body's natural defenses against tumors. It is classified as an immunotherapy agent.

Investigated diseases

Limited-stage small cell lung cancer (LS-SCLC) – This is a type of lung cancer characterized by the presence of small, round cancer cells that grow rapidly. It is termed "limited-stage" when the cancer is confined to one side of the chest and can be treated with a single radiation field. The disease often begins in the bronchi, which are the main airways of the lungs, and can quickly spread to nearby lymph nodes. LS-SCLC is known for its aggressive nature and rapid progression, often leading to symptoms such as coughing, chest pain, and difficulty breathing. The disease is typically diagnosed through imaging tests and biopsies, which reveal the small, oval-shaped cancer cells. As the disease progresses, it may spread to other parts of the body, including the brain, liver, and bones.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507097-41-01Protocol codeJS004-008-III-SCLCEstimated enrolment754 patientsSponsorShanghai Junshi Biosciences Co. Ltd.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).