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Efficacy of Cobolimab, Dostarlimab, and Docetaxel in Advanced Non-Small Cell Lung Cancer Post Anti-PD(L)1 Therapy and Chemotherapy

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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 treatments for Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study involves three different treatment combinations. The first combination includes cobolimab, dostarlimab, and docetaxel. The second combination includes dostarlimab and docetaxel. The third treatment is docetaxel alone. Dostarlimab is also known by its code names WBP-285 and TSR-042, and cobolimab is referred to as GSK4069889A.

The purpose of the study is to compare the effectiveness of these treatment combinations in patients with advanced NSCLC who have previously been treated with other therapies. Participants will be randomly assigned to one of the three treatment groups. The treatments will be given as an infusion, which means they are administered directly into the bloodstream through a vein. The study will monitor the participants over a period to assess how well the treatments work and to observe any side effects.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to track the progress of the treatment. The study aims to provide valuable information on the potential benefits and risks of these treatment combinations for people with advanced Non-Small Cell Lung Cancer.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study assignment

    You will be assigned to one of three different treatment groups through a process called randomization, which means the group is chosen by chance.

    The group assigned depends on whether you receive cobolimab, dostarlimab, or docetaxel, or a combination of these medicines.

  2. Step 2

    Treatment groups

    In the first group, you will receive cobolimab (300 mg) and dostarlimab (500 mg) along with docetaxel (75 mg/m2). These are administered through intravenous infusion, which means the medicine is delivered directly into a vein.

    In the second group, you will receive dostarlimab (500 mg) and docetaxel (75 mg/m2) via intravenous infusion.

    In the third group, you will receive docetaxel (75 mg/m2) alone via intravenous infusion.

  3. Step 3

    Monitoring and safety

    The effectiveness and safety of the treatments are monitored throughout the study.

    The study tracks overall survival, which is the length of time from the date of randomization until death from any cause.

    Medical professionals will observe for any adverse events, which are side effects or unexpected medical occurrences, both during treatment and up to 90 days after the last dose is given.

Who can join the trial?

7 criteria

  • You must be at least 18 years old (or 19 years old if you are in Korea) and be able to understand the study steps and sign a written agreement to participate.
  • You must have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC), which means the cancer has spread or is at an advanced stage, and it must be specifically the squamous or nonsquamous type of cell.
  • You must have received no more than two previous treatments for your advanced cancer. These treatments must only consist of one type of platinum-based chemotherapy (a type of cancer medicine containing platinum, such as cisplatin or carboplatin) and one type of anti-PD-1 or anti-PD-L1 antibody (an immunotherapy drug that helps the immune system fight cancer).
  • You cannot have previously used targeted therapies, such as angiogenesis inhibitors (medicines that stop the growth of new blood vessels that feed tumors).
  • Your cancer must be measurable, meaning a doctor can clearly see and track at least one tumor lesion (an area of abnormal tissue or a tumor) using medical imaging like scans.
  • There must be evidence from medical imaging, such as a scan, that your cancer has progressed (grown or spread) after you received your previous platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 antibody therapy.
  • You must agree to provide a tumor tissue specimen (a sample of the cancer cells) that was collected after your cancer was diagnosed as being advanced or spread. If old samples are not available, you will need to have a biopsy (a procedure to remove a small piece of tissue for testing) before joining the study.

Who cannot join the trial?

14 criteria

  • You cannot participate if you previously took an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug (treatments that help the immune system fight cancer) and had to stop using them permanently because of an adverse event (a side effect or medical problem caused by the treatment).
  • You cannot participate if you had major surgery within 3 weeks before the first dose of the study treatment, or if you have not fully recovered from complications (unintended medical problems) or side effects from a previous surgery. Note that having a port catheter (a small tube placed under the skin to give medicine) surgically implanted does not prevent you from joining.
  • You cannot participate if you have brain metastases (cancer that has spread to the brain) or leptomeningeal metastases (cancer that has spread to the protective membranes covering the brain and spinal cord) that are new or growing. However, if your brain cancer is stable and you have been neurologically stable (your brain functions normally without sudden changes) for 4 weeks and are off corticosteroids (steroid medicines used to reduce swelling), you may be eligible.
  • You cannot participate if you test positive for Hepatitis B surface antigen (a sign of Hepatitis B infection) or if you test positive for Hepatitis C antibodies unless a follow-up RNA test (a test that looks for the actual virus in the blood) confirms you do not have an active infection.
  • You cannot participate if you have an active infection that requires systemic therapy (medicine that travels through the whole body, such as antibiotics) within 1 week of the first study dose.
  • You cannot participate if you have HIV (a virus that attacks the body's immune system).
  • You cannot participate if you have another type of cancer, except for certain skin, bladder, or cervical cancers that were treated and show no signs of returning, or if a previous cancer was cured and has been gone for at least 5 years.
  • You cannot participate if you have previously been treated with anti-TIM-3, anti-CTLA-4, or docetaxel (a type of chemotherapy medicine).
  • You cannot participate if your cancer has specific driver mutations, which are genetic changes like EGFR, ALK, or ROS-1 that cause the cancer to grow. If your tumor has not been tested for these, you cannot join.
  • You cannot participate if your cancer showed disease progression (meaning the cancer grew or got worse) within 8 weeks after starting previous anti-PD-1 or anti-PD-L1 treatments.
  • You cannot participate if you received more than 30 Gy (a measurement of the amount of radiation) of radiation therapy to the lungs within the last 6 months.
  • You cannot participate if you had palliative radiotherapy (radiation intended to relieve pain or symptoms rather than cure the cancer) within 7 days of the first study dose.
  • You cannot participate if you have certain hepatic characteristics (signs of liver issues), such as high levels of ALT, AST, alkaline phosphatase, or bilirubin (substances measured in blood tests to check liver health), or if you have active liver or bile duct disease.
  • You cannot participate if your corrected QT interval (QTc) is too long. The QTc is a measurement of the time it takes for your heart muscle to recharge between beats, adjusted for your heart rate.
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Investigated drugs

  • Dostarlimab

    is a type of immunotherapy that helps the body's own immune system recognize and attack cancer cells.

  • Cobolimab

    is an experimental therapy being tested to see if it can work alongside other treatments to improve the body's immune response against cancer.

  • Docetaxel

    is a type of chemotherapy drug used to stop the growth of cancer cells.

What is already known about the treatment

  • Dostarlimab

    This medication is an immunotherapy drug administered as a liquid through an intravenous infusion into a vein. It is currently approved for certain types of cancer and works by attaching to specific proteins on immune cells to help the body's own defense system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor used primarily to treat specific advanced cancers.

  • Cobolimab

    This substance is an investigational immunotherapy drug that is given to patients via an intravenous infusion. While it is still being studied in clinical trials, it is designed to work by blocking certain pathways in the immune system to help the body fight cancer more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors.

  • Docetaxel

    This is a chemotherapy medication that is administered to patients through an intravenous infusion. It is a well-established treatment used for many different types of cancer to stop cancer cells from dividing and growing. It is classified as a taxane, which works by disrupting the internal structure that allows cells to multiply.

Investigated diseases

Non-small cell lung cancer - This is a type of cancer that begins in the cells of the lung. It is the most common form of lung cancer and involves cells that are not small or round. The disease typically starts in the lining of the airways and can spread to nearby lymph nodes or other parts of the body. As it progresses, the abnormal cells grow and multiply uncontrollably within the lung tissue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-507475-21-00Protocol code213410Estimated enrolment760 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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