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A study of pembrolizumab, cetuximab, and MK-1084 for patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is for people with Nonsquamous Non-small Cell Lung Cancer, a type of lung cancer that does not involve certain specific cell shapes, which has spread or is at an advanced stage. The research focuses on patients who specifically have a KRAS G12C mutation, which is a change in the genetic code of the cancer cells. The purpose of the study is to evaluate the safety and effectiveness of different combinations of new treatments.

Participants may receive several different medications. These include cetuximab, which is given through an intravenous infusion, a method of delivering medicine directly into a vein, and MK-1084, which is taken as a pill. Other medications being studied include pembrolizumab, also given by intravenous infusion. Some people may receive a combination of these new drugs, while others may receive standard treatments like carboplatin or pemetrexed.

During the study, different groups of participants will be assigned to receive different combinations of these medicines to see which ones work best. The process involves regular monitoring to see how the body reacts to the treatments and how the cancer changes over time.

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

    Assignment to a treatment group

    Participation begins with a random assignment to one of the treatment paths. the specific treatment received depends on the assigned group in the study.

  2. Step 2

    Administration of investigational treatments

    One treatment option involves receiving cetuximab, which is an intravenous infusion (medicine delivered directly into a vein) at a dose of 1250 mg.

    Another option includes taking mk-1084 as an oral tablet (medicine taken by mouth).

  3. Step 3

    Administration of combination investigational treatments

    Another treatment option involves receiving keytruda (pembrolizumab) via intravenous infusion at a dose of 400 mg.

    This may be combined with the oral tablet mk-1084.

  4. Step 4

    Administration of comparator treatments

    A comparison treatment group involves receiving carboplatin through intravenous infusion at a dose of 750 mg.

    This is administered alongside pemetrexed, which is also given as an intravenous infusion at a dose of 1250 mg.

Who can join the trial?

8 criteria

  • You must have a confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC), which means the lung cancer is not the small cell type and has spread or grown significantly.
  • Your tumor must show a specific genetic change called a KRAS G12C mutation, which is found either in a piece of the tumor tissue or in circulating tumor DNA (ctDNA), which is small pieces of genetic material from the cancer found in the blood.
  • You must be able to provide a sample of the tumor, either from archival tissue (older samples already stored) or through a new biopsy (taking a small piece of the tumor using a needle or surgical cut) from an area that has not been treated with radiation.
  • Any adverse events (unwanted side effects) from previous cancer treatments must have improved to a mild level or back to your normal state.
  • If you have neuropathy (nerve damage that causes numbness or tingling) or endocrine-related side effects (problems with hormones), they must be mild or well-managed with hormone replacement therapy.
  • If you have human immunodeficiency virus (HIV), it must be well-controlled using antiretroviral therapy (ART), which is medication used to manage the virus.
  • If you have hepatitis B (HBV), the amount of virus in your blood must be undetectable, and if you test positive for the surface antigen (HBsAg), you must have been taking antiviral medicine for at least 4 weeks.
  • If you have hepatitis C (HCV), the amount of virus in your blood must be undetectable.

Who cannot join the trial?

20 criteria

  • You cannot participate if you have small cell lung cancer, which is a specific and aggressive type of lung cancer.
  • You cannot participate if you have a weakened immune system, known as immunodeficiency, or if you are taking long-term steroid therapy (medicines that reduce inflammation) at a high dose.
  • You cannot participate if you are taking any other immunosuppressive therapy, which are medicines that lower your body's ability to fight infections, within 7 days before the study starts.
  • You cannot participate if you have another type of cancer that is currently growing or has needed treatment in the last 3 years.
  • You cannot participate if you have cancer that has spread to the central nervous system (the brain and spinal cord) or if you have carcinomatous meningitis, which is when cancer cells spread to the protective layers covering the brain and spinal cord.
  • You cannot participate if you have an autoimmune disease, which is a condition where the body's immune system attacks its own healthy cells, that required systemic medicine in the last 2 years.
  • You cannot participate if you have or have had pneumonitis or interstitial lung disease, which are conditions involving inflammation or scarring of the lung tissue, that required steroids.
  • You cannot participate if you have a history of receiving a stem cell transplant or a solid organ transplant (such as a kidney or liver transplant).
  • You cannot participate if you have not fully recovered from a major surgery or if you are currently having problems related to a recent surgery.
  • You cannot participate if you have HIV infection along with a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease, which are rare types of cancer or swelling of lymph nodes.
  • You cannot participate if you have inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, that requires medicine to calm the immune system.
  • You cannot participate if you have serious heart or blood vessel problems, such as congestive heart failure (when the heart cannot pump enough blood), unstable angina (chest pain), myocardial infarction (a heart attack), or an irregular heartbeat called arrhythmia.
  • You cannot participate if your heart rhythm shows a specific electrical delay called a prolonged QT interval.
  • You cannot participate if you have had heart or blood vessel issues within the 6 months before the study begins.
  • You cannot participate if you have already received other systemic anticancer treatments for advanced or spreading non-small cell lung cancer (NSCLC).
  • You cannot participate if you stopped previous immunotherapy (treatment that helps the immune system fight cancer) due to severe immune-related adverse events, which are side effects where the immune system attacks healthy organs.
  • You cannot participate if you stopped immunotherapy due to myocarditis (inflammation of the heart muscle) or recurring lung inflammation.
  • You cannot participate if you have previously used a medicine that specifically targets the KRAS gene.
  • You cannot participate if you have received anticancer treatment very recently and have not yet recovered from adverse events, which are side effects or medical problems caused by the treatment.
  • You cannot participate if you have had high-dose radiation therapy to the lungs within the 6 months before the study starts.
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Investigated drugs

  • Cetuximab

    is an investigational medicine given through an IV infusion that works by targeting specific proteins on the surface of cancer cells to help stop them from growing.

  • MK-1084

    is an investigational medicine taken as a pill that is being studied for its ability to target specific genetic mutations in cancer cells.

  • Pembrolizumab

    is an investigational immunotherapy given through an IV infusion that helps the body's own immune system recognize and attack cancer cells.

  • Carboplatin

    is a medication given through an IV infusion that is used as a comparison treatment to help slow or stop the growth of cancer cells.

  • Pemetrexed

    is a medication given through an IV infusion that is used as a comparison treatment to interfere with the way cancer cells grow and divide.

What is already known about the treatment

  • Cetuximab

    This medication is an antineoplastic agent administered through an intravenous infusion. It is a well-established treatment used primarily for certain types of cancer, such as colorectal and head and neck cancers. The drug works by attaching to specific proteins on the surface of cancer cells to block the signals that tell them to grow and divide.

  • MK-1084

    This investigational substance is taken orally in the form of a tablet. It is currently being studied in clinical trials to determine its effectiveness in treating specific types of advanced lung cancer. The drug is designed to target and inhibit specific mutated proteins within cancer cells to stop their growth.

  • Pembrolizumab

    This is a known immunotherapy medication that is administered via intravenous infusion. It is widely used in medical practice to treat various types of cancer by helping the body's own immune system recognize and attack cancer cells. It works by blocking a specific protein that cancer cells use to hide from the immune system.

  • Carboplatin

    This is a chemotherapy medication that is given through an intravenous infusion. It is a standard treatment used for many different types of cancer to slow or stop the growth of tumor cells. The drug works by damaging the DNA inside cancer cells, which prevents them from multiplying and eventually causes them to die.

  • Pemetrexed

    This medication is a chemotherapy drug administered through an intravenous infusion. It is commonly used in the treatment of certain lung cancers and other cancers to interfere with cell growth. The drug works by blocking specific enzymes that cancer cells need to produce the building blocks for their DNA and RNA.

Investigated diseases

Non-small cell lung cancer - This is a type of lung cancer that does not start in the cells that produce mucus. It is characterized by the uncontrolled growth of abnormal cells in the lung tissue. In certain cases, the cancer is driven by a specific genetic mutation known as KRAS G12C. As the disease progresses, the cancer cells may spread from the original site in the lung to other parts of the body. This spread is referred to as metastatic disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521939-36-00Protocol codeMK-3475-01JEstimated enrolment131 patientsSponsorMerck Sharp & Dohme LLC

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).