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A Study of MK-1084 and Drug Combination Versus Pembrolizumab and Chemotherapy for Adults with Advanced Lung Cancer with KRAS G12C Mutation

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What is this trial about?

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

This study involves people with a specific type of lung cancer called nonsquamous non-small cell lung cancer that has a particular genetic change known as KRAS G12C mutation. The cancer is either advanced, meaning it has grown significantly, or metastatic, meaning it has spread to other parts of the body. Participants in this study have not yet received treatment for their advanced or metastatic lung cancer. The study will test different combinations of medications to see which works better. One treatment combination includes MK-1084, which is given as a tablet or film-coated tablet by mouth, together with MK-3475A, which contains pembrolizumab and is given as an injection under the skin. The other treatment combination includes MK-3475A together with chemotherapy medications called pemetrexed and either carboplatin or cisplatin, which are given through a vein.

The purpose of this study is to compare how well MK-1084 combined with MK-3475A works compared to MK-3475A combined with chemotherapy in treating this type of lung cancer, particularly in people whose tumors show a certain marker called PD-L1. The study will look at how long participants live without their cancer getting worse, how long they live overall, whether their tumors shrink or disappear, and how long any response to treatment lasts. The study will also monitor what side effects occur and whether participants need to stop treatment because of these side effects.

During the study, participants will receive one of the two treatment combinations. They will have regular check-ups where doctors will examine them, take blood samples, and perform scans to see how the cancer is responding to treatment. Participants will also be asked to complete questionnaires about their quality of life, including questions about breathing difficulties, coughing, and chest pain. The doctors will track any health problems that occur during treatment and measure changes in symptoms and overall well-being throughout the study.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon entering the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that the assignment is done by chance, similar to flipping a coin.

    The first group will receive MK-1084 (a tablet taken by mouth) in combination with pembrolizumab (a medication given as an injection under the skin).

    The second group will receive pembrolizumab (injection under the skin) in combination with chemotherapy medications, which include pemetrexed and either carboplatin or cisplatin (both given through a vein).

  2. Step 2

    Treatment administration

    If you are assigned to the first group, you will take MK-1084 tablets by mouth. You will also receive pembrolizumab as an injection under the skin at scheduled intervals.

    If you are assigned to the second group, you will receive pembrolizumab as an injection under the skin. Additionally, you will receive chemotherapy through an infusion into a vein. The chemotherapy consists of pemetrexed combined with either carboplatin or cisplatin.

    The specific dosage, frequency, and duration of each medication will be determined according to the study protocol and your individual medical situation.

  3. Step 3

    Regular monitoring visits

    Throughout the study, you will attend regular visits at the study site for monitoring and assessments.

    During these visits, the study team will check your overall health, monitor for any side effects, and assess how the treatment is working.

    These visits may include physical examinations, blood tests, imaging scans, and other procedures as required by the study protocol.

  4. Step 4

    Quality of life assessments

    At certain points during the study, you will be asked to complete questionnaires about your quality of life and symptoms.

    These questionnaires will ask about your overall health status, daily functioning, and specific symptoms such as shortness of breath (dyspnea), cough, and chest pain.

    The information collected will help evaluate how the treatment affects your daily life and well-being.

  5. Step 5

    Disease progression monitoring

    The study team will regularly assess whether your cancer is responding to treatment, staying stable, or progressing.

    This assessment is done using imaging scans and follows standardized criteria called RECIST 1.1, which measures changes in tumor size.

    The primary goal is to measure progression-free survival, which is the length of time during and after treatment that you live without the cancer getting worse.

  6. Step 6

    Safety monitoring

    Throughout the study, any side effects or adverse events you experience will be carefully recorded and monitored.

    You should report any new symptoms or changes in your health to the study team promptly.

    If serious side effects occur, the study team may adjust your treatment or, if necessary, discontinue your participation in the study.

  7. Step 7

    Continuation of treatment

    You will continue receiving the assigned treatment as long as it is beneficial and you do not experience unacceptable side effects.

    The treatment may continue until your cancer progresses, side effects become too severe, or you decide to withdraw from the study.

    The study team will regularly evaluate whether continuing treatment is appropriate for you.

  8. Step 8

    Long-term follow-up

    After completing the treatment phase, you will enter a follow-up period where the study team will continue to monitor your health status.

    During this period, information about your overall survival and long-term outcomes will be collected.

    The study is expected to continue until approximately August 2032, though your individual participation duration may vary.

Who can join the trial?

6 criteria

  • You must have nonsquamous non-small cell lung cancer, which is a type of lung cancer that does not include certain flat cells. Your cancer must be at an advanced stage, meaning Stage IIIB, Stage IIIC, or Stage IV (M1a, M1b, or M1c). This means the cancer has spread and cannot be removed by surgery or treated with combined chemotherapy and radiation to cure it.
  • Your tumor must have a specific change in a gene called KRAS G12C mutation, which is a particular alteration in the cancer cells.
  • Your cancer must have spread to other parts of the body (metastatic) or be at an advanced stage.
  • If you have HIV, which is a virus that affects the immune system, your infection must be well controlled with antiretroviral therapy, which are medicines that keep the virus under control.
  • You can be male or female.
  • You must be an adult, meaning 18 years of age or older.

Who cannot join the trial?

10 criteria

  • The patient has a type of lung cancer called squamous NSCLC (squamous non-small cell lung cancer). This study is only for patients with nonsquamous NSCLC, which is a different type of lung cancer.
  • The patient does not have a specific genetic change in their tumor called KRAS G12C mutation. This is a particular alteration in the genes of the cancer cells that must be present to join this study.
  • The patient's cancer is not advanced or metastatic. Advanced means the cancer has grown significantly, and metastatic means it has spread to other parts of the body.
  • The patient's tumor does not show PD-L1 positive status with a TPS of 1% or higher. PD-L1 is a protein found on some cancer cells, and TPS (Tumor Proportion Score) measures how much of this protein is present. A score of at least 1% is required for this study.
  • The patient has previously received treatment for their advanced or metastatic lung cancer. This study is looking for patients who have not yet been treated for their advanced disease.
  • The patient has certain other serious medical conditions or diseases that could interfere with the study treatment or their safety.
  • The patient is pregnant or breastfeeding.
  • The patient has an active infection that requires treatment.
  • The patient has received certain types of cancer treatments recently that could affect the study results.
  • The patient has a condition affecting their immune system or is taking medications that suppress the immune system.
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Investigated drugs

  • MK-1084

    is an investigational medication being tested in this clinical trial. It is given in combination with other treatments to see if it can help fight cancer in patients with a specific type of lung cancer that has a particular genetic change called KRAS G12C mutation.

  • Pembrolizumab

    is a cancer treatment that works by helping your immune system recognize and fight cancer cells. In this study, it is given as an injection under the skin along with another substance called berahyaluronidase alfa, and together they are referred to as MK-3475A.

  • Berahyaluronidase alfa

    is a substance that helps pembrolizumab be absorbed better when given as an injection under the skin. It is combined with pembrolizumab in a product called MK-3475A.

  • Pemetrexed

    is a chemotherapy medication that stops cancer cells from growing and dividing. It is used in combination with a platinum-based chemotherapy drug to treat lung cancer.

  • Carboplatin

    is a platinum-based chemotherapy medication that damages the DNA of cancer cells, which helps stop them from growing and spreading. It is used together with pemetrexed as one of the treatment options in this study.

  • Cisplatin

    is another platinum-based chemotherapy medication similar to carboplatin. It also works by damaging cancer cell DNA to prevent the cancer from growing. It can be used instead of carboplatin in combination with pemetrexed as a treatment option in this study.

What is already known about the treatment

  • MK-1084

    MK-1084 is an investigational medication currently being studied in clinical trials for the treatment of advanced or metastatic lung cancer that has a specific genetic mutation called KRAS G12C. This medication is given in combination with other cancer treatments as part of a first-line therapy approach, meaning it is used when patients are first diagnosed and have not yet received treatment for their advanced disease. MK-1084 works by targeting and blocking the abnormal KRAS G12C protein, which is a mutated form of a protein that normally helps control cell growth but in cancer cells causes uncontrolled growth and tumor formation. It belongs to a class of drugs known as targeted therapies, specifically KRAS G12C inhibitors, which are designed to attack cancer cells with this particular genetic change while minimizing damage to healthy cells.

  • MK-3475A

    MK-3475A is an investigational combination medication that contains pembrolizumab, an immunotherapy drug, along with berahyaluronidase alfa, which helps the body absorb the medicine when given as an injection under the skin. This medication is currently being evaluated in clinical trials for treating advanced lung cancer with specific genetic characteristics, particularly in combination with other cancer therapies. The pembrolizumab component works by blocking a protein called PD-1 on immune cells, which allows the body's immune system to recognize and attack cancer cells more effectively, while the berahyaluronidase alfa breaks down a substance in tissues that would otherwise slow absorption. It is classified as an immunotherapy or immune checkpoint inhibitor, representing a modern approach to cancer treatment that harnesses the patient's own immune system to fight the disease.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and is the most common form of lung cancer. The disease occurs when cells in the lung tissue grow abnormally and uncontrollably, forming tumors. In advanced stages, the cancer spreads beyond the lungs to other parts of the body, which is called metastatic disease. The nonsquamous type refers to cancer cells that do not have a flat, scale-like appearance under the microscope. Some cases involve specific genetic mutations, such as KRAS G12C, which affects how cancer cells grow and respond to certain factors. The disease progresses as cancer cells continue to multiply and spread through the bloodstream or lymphatic system to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514500-14-00Protocol codeMK-1084-007Estimated enrolment749 patientsSponsorMerck Sharp & Dohme LLC

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