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Study of visugromab and nivolumab with or without docetaxel as second-line treatment for patients with metastatic non-squamous non-small cell lung cancer

Fast replyRegistered drugNo 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 focuses on treating metastatic non-squamous non-small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The study tests a combination of medications: visugromab (also known as CTL-002), nivolumab, and docetaxel. These medications are given through intravenous infusion, which means they are administered directly into a vein.

The purpose of this study is to evaluate how well the combination of visugromab and nivolumab works with or without docetaxel compared to using docetaxel alone in patients who have already received one previous treatment for their cancer. Some patients will receive an inactive substance (placebo) instead of one of the study medications.

The treatment period may last up to 36 months. During the study, patients will receive regular medical examinations and various tests to monitor their health and how well the treatment is working. The medications being tested work in different ways to fight cancer: visugromab is an antibody that targets a specific protein, nivolumab helps the immune system fight cancer cells, and docetaxel is a chemotherapy drug that stops cancer cells from growing.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your doctor will confirm the diagnosis of stage IV non-squamous non-small cell lung cancer

    Medical tests will check your organ function, including blood tests for bone marrow function, kidney, liver, and thyroid function

    Your medical history will be reviewed to confirm you have received previous treatment that included immunotherapy

  2. Step 2

    Treatment group assignment

    You will be randomly assigned to one of the treatment groups

    The study uses a placebo-controlled design, which means you may receive either active medications or placebo

  3. Step 3

    Treatment administration

    You will receive medications through intravenous infusion

    The treatment may include combinations of: visugromab, nivolumab, and docetaxel

    Treatment will continue until specific end points are reached or your doctor determines it should be stopped

  4. Step 4

    Regular monitoring

    Your tumor response will be assessed using imaging scans

    Regular blood tests will monitor your health status

    Your doctor will track any side effects you may experience

    You will complete questionnaires about your symptoms and well-being

  5. Step 5

    Follow-up period

    After completing treatment, you will continue to be monitored for safety

    Follow-up visits will track your long-term health status

    The study is expected to continue until October 2029

Who can join the trial?

17 criteria

  • You must have confirmed stage IV non-squamous non-small cell lung cancer through tissue or cell examination
  • You must be at least 18 years old when signing the consent form
  • You must have previously received treatment for metastatic cancer that included immunotherapy (anti-PD(L)1 therapy) for at least 12 weeks
  • Your previous cancer treatment must have stopped working while you were still receiving immunotherapy
  • You must have measurable tumors that can be assessed by imaging scans
  • You must have a life expectancy of at least 3 months as determined by your doctor
  • Your physical ability status must be good enough to care for yourself (ECOG score of 0 or 1)
  • You must have adequate organ function, including:
    • Healthy blood cell counts
    • Good kidney function
    • Proper liver function
    • Normal thyroid function
    • Normal blood clotting ability
    • Any side effects from previous cancer treatments must have resolved to mild level or returned to normal, except for hair loss and tiredness
    • If you are a woman who can become pregnant, you must:
      • Have a negative pregnancy test within 7 days before starting treatment
      • Use effective birth control during the study and for 150-180 days after the last dose
      • If you are a man with female partners who can become pregnant, you must use effective birth control during the study and for 150-180 days after the last dose
      • You must be able to understand the study purpose and agree to participate by signing an informed consent form

Who cannot join the trial?

14 criteria

  • Known history of hypersensitivity (severe allergic reactions) to any of the study drugs or their components
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • History of other cancers within the last 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions, including:
    • Heart attack within the last 6 months
    • Unstable heart disease
    • Uncontrolled high blood pressure
    • Active or chronic infections, including:
      • Hepatitis B
      • Hepatitis C
      • HIV
      • Significant liver disease or abnormal liver function tests
      • Severe kidney problems requiring dialysis
      • Current participation in other clinical trials or treatment with other investigational drugs within 4 weeks before starting this study
      • Pregnant or breastfeeding women
      • Unable to understand or comply with study procedures and requirements
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Investigated drugs

  • Visugromab

    is an experimental medication being studied for treating non-small cell lung cancer. It works by targeting specific proteins that may help fight cancer cells.

  • Nivolumab

    is a type of immunotherapy medication that helps the body's immune system recognize and fight cancer cells. It works by blocking certain proteins that prevent the immune system from attacking cancer cells.

  • Docetaxel

    is a chemotherapy medication used to treat various types of cancer, including lung cancer. It works by interfering with the growth and spread of cancer cells in the body.

What is already known about the treatment

  • Visugromab

    An investigational medication being studied in clinical trials for metastatic non-squamous non-small cell lung cancer treatment. It is administered in combination with nivolumab and docetaxel, representing a novel therapeutic approach in second-line cancer treatment. The drug is currently undergoing Phase 2 clinical trials to evaluate its efficacy and safety.

  • Nivolumab

    An immunotherapy medication administered intravenously that works by blocking the PD-1 protein on immune cells, helping the body's immune system to better fight cancer cells. It belongs to the class of checkpoint inhibitors and is approved for treating various types of cancer, including non-small cell lung cancer, with a well-documented safety profile in clinical practice.

  • Docetaxel

    A chemotherapy medication given through intravenous infusion that belongs to the taxane family of drugs. It works by disrupting cell division and preventing cancer cells from growing and spreading, commonly used as a standard second-line treatment for non-small cell lung cancer. The drug has been well-established in cancer treatment protocols for many years with proven efficacy in various types of cancer.

Investigated diseases

Non-small cell lung cancer (NSCLC) - A type of lung cancer that begins in the larger lung cells and grows more slowly than small cell lung cancer. When the cancer spreads beyond the lungs to other parts of the body, it is called metastatic non-squamous NSCLC. The disease typically develops in the cells that line the air passages in the lungs, with non-squamous types including adenocarcinoma and large cell carcinoma. As the disease progresses, cancer cells can break away from the primary tumor and spread through the bloodstream or lymphatic system to other organs. The condition affects the lungs' ability to function normally and can impact breathing and oxygen exchange.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516794-70-00Protocol codeCTL-002-004Estimated enrolment131 patientsSponsorCatalYm GmbH

sourced from the EU Clinical Trials Register and site verification

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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).