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A study of MK-1084 and pembrolizumab for patients with resected KRAS G12C-mutant non-small cell lung cancer

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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 Non-small Cell Lung Cancer that has been completely removed through surgery. The cancer specifically includes a KRAS G12C mutation, which is a change in the genetic instructions within the cancer cells. The purpose of the study is to compare the effectiveness of different treatment combinations in preventing the cancer from returning.

Participants in the study may receive MK-1084, which is an oral film-coated tablet, in combination with pembrolizumab, an injectable medication. Some individuals might receive a placebo instead of the MK-1084. These treatments are being studied alongside previous or concurrent use of chemotherapy, which includes drugs such as carboplatin, pemetrexed, or cisplatin. These medications are typically given through an intravenous infusion, a method of delivering fluids directly into a vein.

The study is designed to observe how long patients remain free from the disease after their initial treatment. Participants will be monitored over time to track their health status and how they respond to the different medication combinations provided during the trial.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation

    Participation in the study begins following the surgical removal of the tumor.

    The treatment involves receiving either a test medication or a placebo (an inactive substance) in combination with pembrolizumab.

  2. Step 2

    Medication administration

    One group receives MK-1084, which is an oral film-coated tablet, while the other group receives a placebo for MK-1084.

    All participants receive pembrolizumab (also known as MK-3475A) as a subcutaneous injection, which means the solution for injection is administered just under the skin. the dose for pembrolizumab is 790 mg.

Who can join the trial?

11 criteria

  • You must have a diagnosis of non-small cell lung cancer (NSCLC), which is a common type of lung cancer that does not start in the specific cells that produce mucus.
  • The cancer cells must be nonsquamous, meaning they are not the specific type of cells known as squamous cells.
  • The cancer must be at Stage IIA-IIIB (N2), which describes how much the cancer has spread, specifically involving nearby lymph nodes (N2).
  • The tumor must have been completely resected, meaning the surgeon has successfully removed all visible parts of the tumor through surgery.
  • Your tumor must show a specific genetic change called a KRAS G12C mutation, which is a change in the DNA of the cancer cells.
  • The time between your last surgery or your last dose of platinum-based chemotherapy (a type of medicine used to kill cancer cells) and your first dose of the study treatment must be 12 weeks or less.
  • Medical scans, such as a computed tomography (CT) scan (a detailed X-ray picture) or an MRI (a scan using magnets and radio waves), must show no evidence of disease within 28 days before joining the study.
  • You must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and your overall health.
  • If you have HIV, it must be well-controlled with antiretroviral therapy (medicine used to manage the virus).
  • If you have Hepatitis B, you must be taking antiviral therapy (medicine to fight the virus) and have an undetectable viral load, meaning the amount of virus in your blood is so low it cannot be measured.
  • If you have a history of Hepatitis C, your viral load must be undetectable.

Who cannot join the trial?

10 criteria

  • You have a diagnosis of small cell lung cancer, a specific type of lung cancer, or tumors that contain certain cell types like neuroendocrine tumors, sarcomatoid carcinoma, or cancer located in the superior sulcus (the area at the very top of the lung near the collarbone).
  • You have not fully recovered from a major surgery or are still experiencing surgical complications (problems following a medical procedure).
  • You are living with HIV and have a history of Kaposi's sarcoma or Multicentric Castleman's Disease (rare types of cancer or immune system disorders).
  • You have active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis (conditions that cause swelling and irritation in the digestive tract), that requires immunosuppressive medication (drugs that lower the body's immune response).
  • You have had significant or uncontrolled cardiovascular disease (heart problems) or cerebrovascular disease (problems with blood flow to the brain, such as a stroke) within the last 6 months.
  • You are unable to swallow pills or have a gastrointestinal disorder (a problem with the stomach or intestines) that prevents your body from properly absorbing medicine, such as having had part of your stomach removed or having a bowel obstruction (a blockage in the intestines).
  • You have another type of malignancy (cancer) that is currently growing or has been treated within the last 3 years.
  • You have an active autoimmune disease (a condition where the immune system attacks healthy cells) that has required systemic treatment (medicine that travels through the entire body) in the last 2 years.
  • You have a history of pneumonitis or interstitial lung disease (inflammation or scarring of the lung tissue) that required the use of steroids (powerful anti-inflammatory medicines), or you currently have these conditions.
  • You have an active infection that requires systemic therapy (medicine, such as antibiotics, that works throughout the whole body).
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Investigated drugs

  • MK-1084

    is an experimental oral tablet being studied to see if it helps prevent the cancer from returning.

  • Pembrolizumab

    is an immunotherapy medication given by injection under the skin that helps the body's immune system recognize and fight cancer cells.

  • Carboplatin

    is a type of chemotherapy drug given through a vein to help kill cancer cells.

  • Pemetrexed

    is a chemotherapy medication administered through an intravenous infusion to treat cancer.

  • Cisplatin

    is a chemotherapy drug given through a vein to stop the growth of cancer cells.

What is already known about the treatment

  • MK-1084

    This medication is an experimental drug currently being studied in clinical trials and is taken orally as a film-coated tablet. It is classified as a targeted therapy designed to treat specific types of lung cancer. At the molecular level, it works by blocking a specific mutated protein called KRAS G12C that helps cancer cells grow and survive.

  • Pembrolizumab

    This is an approved immunotherapy medication administered as a solution via a subcutaneous injection under the skin. It is widely used to treat various types of cancer by helping the body's own immune system recognize and attack cancer cells. The drug works by blocking a specific protein on immune cells that prevents them from attacking the tumor.

  • Carboplatin

    This is a well-established chemotherapy drug that is administered through an intravenous infusion into a vein. It is used to treat many different types of cancer, including lung cancer. The medication works by damaging the DNA within cancer cells, which prevents them from dividing and growing.

  • Pemetrexed disodium

    This is a standard chemotherapy medication given as an intravenous infusion directly into the bloodstream. It is primarily used to treat certain types of lung cancer. At the molecular level, it works by interfering with the chemicals that cancer cells need to produce DNA and replicate themselves.

  • Cisplatin

    This is a widely used chemotherapy drug that is administered to patients through an intravenous infusion. It is a key treatment for various cancers, including non-small cell lung cancer. The drug works by binding to the DNA of cancer cells and causing damage that triggers cell death.

Investigated diseases

Non-small cell lung cancer - This is a type of cancer that starts in the cells of the lung, most commonly in the cells that line the air passages. It often develops from abnormal cell growth that forms tumors in one or both lungs. The disease can progress from localized stages to more advanced stages where it spreads to nearby lymph nodes or other parts of the body. In certain cases, specific genetic mutations like KRAS G12C drive the growth and spread of these cancer cells.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517337-41-00Protocol codeMK-1084-013Estimated enrolment358 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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