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A study of MK-1084 and a drug combination for patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutations.

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 study focuses on individuals with advanced or metastatic Non-small Cell Lung Cancer, which is a type of lung cancer that has spread to other parts of the body. The research specifically targets patients whose cancer cells contain a KRAS G12C mutation, a specific genetic change that helps the cancer grow. The purpose of the study is to evaluate the safety and how well different combinations of experimental medicines work for this specific condition.

Several different medications are being studied, which may be given alone or in combination with other treatments. These include MK-1084, an oral tablet, as well as patritumab deruxtecan and sacituzumab tirumotecan, which are administered through intravenous infusion, a method where medicine is delivered directly into a vein. Other possible treatments include cetuximab. Some participants may also receive corticosteroids, which are medicines used to reduce inflammation.

During the study, participants will receive different combinations of these medications to see how they affect the cancer. The research will monitor how the body reacts to the treatments and whether the cancer shrinks or stops growing. The course of the study involves regular medical monitoring to track the effects of the drugs and any side effects that may occur.

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

    Participation in the study

    The study begins upon joining the trial to evaluate the safety and effectiveness of different medication combinations for non-small cell lung cancer, a type of lung cancer that does not start in the mucus-producing cells.

    The treatment involves receiving different investigational agents, which are medications currently being studied to see if they are safe and effective.

  2. Step 2

    Administration of oral medication

    One part of the treatment involves taking mk-1084, which is provided as a film-coated tablet to be taken by mouth.

    This oral medication is administered as part of a combination therapy.

  3. Step 3

    Administration of intravenous infusions

    Other treatments are delivered through an intravenous infusion, which means the medicine is put directly into a vein through a needle or tube.

    The possible medications received via infusion include patritumab deruxtecan (provided as a powder for solution), sacituzumab tirumotecan (provided as a solution for injection), or cetuximab.

  4. Step 4

    Additional treatments

    During the trial, corticosteroids for local oral treatment may be used. these are medicines taken by mouth to treat specific areas inside the mouth.

Who can join the trial?

8 criteria

  • You must have a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer, which means the cancer is an advanced type that has spread to other parts of the body.
  • Your cancer must be confirmed through histology (looking at cells under a microscope) or cytology (looking at individual cells).
  • Your tumor tissue or circulating tumor DNA, which is tiny pieces of genetic material from the cancer found in the blood, must show a specific genetic change called a KRAS G12C mutation.
  • Your cancer must have continued to grow or get worse even after you received one or two previous treatments involving PD-1 or PD-L1 inhibitors (drugs that help the immune system fight cancer) and platinum-based chemotherapy (a type of powerful medicine used to kill cancer cells).
  • You must be able to provide an old sample of your tumor tissue, called an archival sample, from a part of the tumor that has not been treated with radiation.
  • You must be able to provide a new tissue sample through a biopsy, which is a procedure to remove a small piece of tissue for testing, from a part of the tumor that has not been treated with radiation.
  • If you have HIV, your infection must be well-controlled using antiretroviral therapy, which is the daily medication used to manage the virus.
  • The study is open to both males and females within the required age range.

Who cannot join the trial?

15 criteria

  • You have been diagnosed with small cell lung cancer, which is a different type of lung cancer, or a mix of cancer types that includes small cell elements.
  • You have received a live vaccine, which is a type of vaccine that uses a weakened version of a germ, within 30 days before your first dose of the study treatment.
  • You have an immunodeficiency, which means your body's immune system is not working correctly, or you are taking systemic steroids or other immunosuppressive therapy (medicines that lower your body's ability to fight infection) within 7 days before the first dose.
  • You have another type of malignancy (cancer) that is currently growing or has needed treatment in the last 3 years.
  • You have a history of or currently have pneumonitis (inflammation of lung tissue) or interstitial lung disease (a group of disorders that cause scarring of lung tissue) that required the use of steroids.
  • You have an active infection that requires systemic therapy (medicine that travels through your whole body, such as pills or injections).
  • You have not fully recovered from a major surgery or are experiencing ongoing problems from a recent surgery.
  • You have severe lung problems caused by other sudden illnesses.
  • You have metastases (cancer that has spread) in the central nervous system (the brain and spinal cord) or carcinomatous meningitis (cancer that has spread to the protective layers covering the brain and spinal cord).
  • You have inflammatory bowel disease (a condition causing inflammation in your digestive tract) that is active and requires medicine to lower your immune system, or you have a history of this condition.
  • There is evidence of leptomeningeal disease, which is cancer that has spread to the fluid and membranes surrounding the brain and spinal cord.
  • You have an uncontrolled or serious cardiovascular disorder (heart disease) or cerebrovascular disease (conditions affecting blood flow to the brain, such as a stroke) before being assigned to the study.
  • You have certain eye conditions, such as significant corneal disease (problems with the clear front part of the eye), a history of severe dry eye syndrome, Meibomian gland disease (problems with oil glands in the eyelids), or blepharitis (inflammation of the eyelids).
  • You are living with HIV and have a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease (specific types of rare cancers or immune system disorders).
  • You have previously been treated with a medicine that targets the KRAS gene.
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Investigated drugs

  • Patritumab deruxtecan

    is an investigational medicine given through an intravenous infusion to target specific proteins on cancer cells.

  • MK-1084

    is an investigational medicine taken by mouth in tablet form.

  • Sacituzumab tirumotecan

    is an investigational medicine given through an intravenous infusion to target specific proteins on cancer cells.

  • Cetuximab

    is a medicine given through an intravenous infusion used to target certain growth signals in cancer cells.

What is already known about the treatment

  • Patritumab deruxtecan

    This medication is an investigational antibody-drug conjugate administered as a powder that is mixed into a solution and given through an intravenous infusion. It is currently being studied in clinical trials for its ability to treat specific types of advanced lung cancer. The drug works by attaching to a specific protein on the surface of cancer cells and then releasing a powerful medicine directly into those cells to destroy them. This treatment is classified as a targeted chemotherapy agent.

  • MK-1084

    This is an investigational oral medication taken in the form of a film-coated tablet. It is currently undergoing research to determine its effectiveness in treating patients with specific genetic mutations in non-small cell lung cancer. The drug is designed to work at a molecular level by blocking certain signals that allow cancer cells to grow and divide. It is pharmacologically classified as a targeted oral therapy.

  • Sacituzumab tirumotecan

    This investigational drug is administered as a solution through an intravenous infusion. It is presently being studied in clinical research for the treatment of advanced cancers. The medication functions as an antibody-drug conjugate, which means it seeks out specific markers on cancer cells to deliver a potent dose of medicine directly to the tumor. This substance belongs to the pharmacological class of targeted antibody-drug conjugates.

  • Cetuximab

    This medication is a known cancer treatment that is administered via intravenous infusion. It is commonly used in medical practice to treat certain types of tumors by targeting specific growth signals. The drug works by binding to receptors on the surface of cancer cells, which prevents them from receiving the signals they need to multiply. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Non-small cell lung cancer - This is a type of cancer that begins in the cells of the lungs. It is characterized by the uncontrolled growth of abnormal cells in the lung tissue. The disease can start in the lining of the airways or in the lung tissue itself. As it progresses, the cancer cells may spread from their original location to other parts of the lungs or to different organs in the body. It accounts for the majority of lung cancer cases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512248-47-00Protocol codeMK-3475-01FEstimated enrolment190 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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