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Study Comparing Ivonescimab and Chemotherapy with Pembrolizumab and Chemotherapy for Patients with Metastatic Squamous Non-small Cell Lung Cancer

Verified siteRegistered 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 is focused on studying treatments for Metastatic Squamous Non-small Cell Lung Cancer, a type of lung cancer that has spread to other parts of the body. The study will compare two different treatment combinations. One group will receive a combination of ivonescimab (also known by the code name AK112 / SMT112) with chemotherapy drugs such as carboplatin and paclitaxel or nab-paclitaxel. The other group will receive pembrolizumab (also known as Keytruda) combined with the same chemotherapy drugs. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to compare the overall survival of patients receiving these different treatment combinations. Participants will be randomly assigned to one of the two groups. The study will involve regular visits to the clinic for treatment and monitoring. Treatments will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will last for a period of up to 24 months, during which participants will receive their assigned treatments and undergo regular health assessments to monitor their response to the treatment and any side effects.

Throughout the study, participants will be closely monitored for their health and well-being. The study aims to provide valuable information on the effectiveness and safety of these treatment combinations for patients with Metastatic Squamous Non-small Cell Lung Cancer. Participants will also be assessed for any immune response to the treatments, such as the development of antibodies against ivonescimab. The results of this study could help improve treatment options for this type of lung cancer in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit where you will receive detailed information about the trial. This includes understanding the purpose, procedures, and potential risks and benefits.

    You will be asked to sign a written informed consent form to confirm your voluntary participation.

  2. Step 2

    Screening tests

    You will undergo a series of screening tests to ensure you meet the eligibility criteria. These tests will assess your organ function, including blood tests for hematology, kidney, and liver function.

    A pregnancy test will be conducted for female patients of childbearing potential.

  3. Step 3

    Randomization

    If eligible, you will be randomly assigned to one of two treatment groups. This means you will either receive ivonescimab combined with chemotherapy or pembrolizumab combined with chemotherapy.

  4. Step 4

    Treatment administration

    You will receive your assigned treatment through an intravenous infusion. This involves receiving medication directly into your bloodstream through a vein.

    The medications used include paclitaxel, paclitaxel albumin-bound, carboplatin, ivonescimab, and pembrolizumab. The specific combination and dosage will depend on your assigned group.

  5. Step 5

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and imaging studies to assess the progress of your condition.

    The frequency and duration of these visits will be determined by the study protocol.

  6. Step 6

    End of treatment

    Once the treatment phase is complete, you will have a final visit to evaluate your overall health and the outcomes of the treatment.

    You may be asked to continue attending follow-up visits for a specified period to monitor long-term effects.

Who can join the trial?

14 criteria

  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of Metastatic Squamous Non-small Cell Lung Cancer (Stage IV).
  • Must have a Tumor Proportion Score (TPS) with PD-L1 expression or provide tissue for measurement of PD-L1 expression. PD-L1 is a protein that can affect the immune system's ability to fight cancer.
  • Must have at least one measurable tumor that is not in the brain.
  • Must not have received any prior systemic treatment for metastatic Non-small Cell Lung Cancer (NSCLC). Previous treatments are allowed if they were completed at least 12 months before the cancer spread.
  • Must have an ECOG performance status score of 0 or 1. This score measures how well you can perform daily activities.
  • Must have an expected life expectancy of at least 3 months.
  • Must have adequate organ function, including:
    • Blood: Sufficient levels of neutrophils, platelets, and hemoglobin.
    • Kidneys: Sufficient creatinine clearance or estimated glomerular filtration rate (eGFR).
    • Liver: Acceptable levels of bilirubin, AST, and ALT.
    • Blood clotting: Normal prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT).
    • Female patients of childbearing age must have a negative pregnancy test before starting the study and agree to use effective contraception during the study and for 120 days after the last dose.
    • Male patients must agree to use effective contraception during the study and for 120 days after the last dose, and until 6 months after the last dose of carboplatin.
    • Must voluntarily sign a written informed consent form.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that have spread to other parts of the body cannot participate.
  • Patients who have had another cancer in the past, unless it was a type that is not expected to come back, cannot participate.
  • Patients who have had a serious allergic reaction to any of the study drugs cannot participate.
  • Patients with uncontrolled or serious heart problems cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments for cancer within a specific time frame before the study starts cannot participate.
  • Patients with a history of certain lung diseases cannot participate.
  • Patients who have had a major surgery within a specific time frame before the study starts cannot participate.
  • Patients with a history of drug or alcohol abuse that could interfere with the study cannot participate.
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Investigated drugs

  • Ivonescimab

    is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat a type of lung cancer called metastatic squamous non-small cell lung cancer. In this trial, ivonescimab is combined with chemotherapy drugs to see if it can improve the survival of patients compared to another treatment option.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It is already used to treat various types of cancer, including lung cancer. In this trial, pembrolizumab is combined with chemotherapy to see how well it works compared to the new medication, ivonescimab, when both are used as first-line treatments for metastatic squamous non-small cell lung cancer.

  • Carboplatin

    is a chemotherapy drug used to treat different types of cancer, including lung cancer. It works by stopping cancer cells from growing and dividing. In this trial, carboplatin is used in combination with other medications to see if it can help improve the treatment of metastatic squamous non-small cell lung cancer.

  • Paclitaxel

    is another chemotherapy drug used to treat various cancers, including lung cancer. It works by interfering with the normal function of microtubules during cell division, which helps stop the growth of cancer cells. In this study, paclitaxel is combined with other treatments to evaluate its effectiveness in treating metastatic squamous non-small cell lung cancer.

  • Nab-paclitaxel

    is a form of the chemotherapy drug paclitaxel that is bound to a protein called albumin. This formulation can help deliver the drug more effectively to cancer cells. In this trial, nab-paclitaxel is used alongside other medications to see if it can improve outcomes for patients with metastatic squamous non-small cell lung cancer.

What is already known about the treatment

  • Ivonescimab

    Ivonescimab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic squamous non-small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells more effectively. Ivonescimab is classified as an immunotherapy drug, which means it helps the body's immune system fight cancer.

  • Pembrolizumab

    Pembrolizumab is also given as an intravenous infusion, allowing it to enter the bloodstream directly. It is an established medication in the treatment of various cancers, including metastatic squamous non-small cell lung cancer. Pembrolizumab works by blocking a protein called PD-1 on immune cells, which helps the immune system to detect and destroy cancer cells. It is classified as a checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses against cancer.

Investigated diseases

Metastatic Squamous Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the squamous cells, which are flat cells that line the inside of the airways in the lungs. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. The term "metastatic" indicates that the cancer has spread from the lungs to other parts of the body. As the disease progresses, it can invade nearby tissues and organs, leading to a variety of symptoms depending on the areas affected. The cancer cells can travel through the bloodstream or lymphatic system to form new tumors in other organs. This spread can complicate the disease and affect the overall function of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504989-37-00Protocol codeSMT112-3003Estimated enrolment400 patientsSponsorSummit Therapeutics Inc.

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