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Study of MK-1084 and Pembrolizumab for First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation and High PD-L1 Levels

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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 a type of lung cancer known as non-small cell lung cancer (NSCLC). The study is specifically looking at cases where the cancer has a mutation called KRAS G12C and where a protein called PD-L1 is present in more than 50% of the cancer cells. The trial will test a new treatment combination to see how effective it is as a first treatment option for patients with this type of cancer.

The treatment being studied involves a combination of two medications: MK-1084 and pembrolizumab. Pembrolizumab is also known by the brand name KEYTRUDA and is given as an infusion, which means it is delivered directly into the bloodstream through a vein. MK-1084 is taken as a tablet. Some participants in the study will receive pembrolizumab with MK-1084, while others will receive pembrolizumab with a placebo, which looks like the real medication but does not contain any active ingredients. The purpose of the study is to compare the effectiveness of these two treatment combinations.

Participants in the study will receive their assigned treatment and will be monitored over a period of time to see how their cancer responds. The study will look at how long participants live without their cancer getting worse, known as progression-free survival, and overall survival, which is the length of time participants live after starting the treatment. The study will also track any side effects experienced by participants and how the treatment affects their quality of life. This information will help researchers understand the potential benefits and risks of the new treatment combination for people with this specific type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of non-small cell lung cancer (NSCLC) and ensuring the presence of specific genetic markers such as the KRAS G12C mutation and PD-L1 expression in more than 50% of tumor cells.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to one of two groups. One group receives MK-1084 in combination with pembrolizumab, while the other group receives a placebo with pembrolizumab.

  3. Step 3

    Medication administration

    For those receiving MK-1084, the medication is administered orally in tablet form. Pembrolizumab is given as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes measuring progression-free survival (PFS) and overall survival (OS).

    Participants are also evaluated for changes in quality of life and physical functioning using standardized questionnaires.

  5. Step 5

    Completion of treatment

    The treatment continues until the study's end date or until specific criteria for discontinuation are met, such as adverse events or disease progression.

Who can join the trial?

9 criteria

  • Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC). This means the type of lung cancer has been identified through specific tests.
  • Must be newly diagnosed with Stage IV cancer, which is an advanced stage where cancer has spread to other parts of the body.
  • Must provide tumor tissue showing that more than 50% of the tumor cells have PD-L1 expression. PD-L1 is a protein that can affect how the immune system responds to cancer.
  • Must provide tumor tissue showing the presence of a specific mutation called KRAS G12C. This is a change in the cancer cells that can affect how they grow.
  • If there were side effects from previous cancer treatments, they must have improved to a mild level or returned to the state before treatment.
  • If infected with HIV, the virus must be well controlled with medication. HIV is a virus that affects the immune system.
  • If positive for Hepatitis B, must have been on antiviral therapy for at least 4 weeks and have no detectable virus in the blood. Hepatitis B is a liver infection caused by a virus.
  • If there is a history of Hepatitis C infection, the virus must not be detectable in the blood. Hepatitis C is another type of liver infection caused by a virus.
  • Both men and women can participate in the study.

Who cannot join the trial?

4 criteria

  • Patients with other types of cancer besides non-small cell lung cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.
  • Patients who have any medical condition or situation that the study doctors think would make it unsafe for them to participate cannot join the study.
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Investigated drugs

  • MK-1084

    is an investigational medication being studied for its potential to treat certain types of cancer. In this trial, it is being tested in combination with another medication to see if it can help improve outcomes for patients with a specific type of lung cancer that has a particular genetic mutation.

  • Pembrolizumab

    is a medication used to help the immune system fight cancer. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this trial, it is being used in combination with MK-1084 to see if the combination is more effective than using pembrolizumab alone.

What is already known about the treatment

  • MK-1084

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer, specifically in patients with a KRAS G12C mutation. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication is for metastatic non-small cell lung cancer with a high expression of PD-L1. MK-1084 works by targeting the KRAS G12C mutation, which is a specific alteration in cancer cells, potentially inhibiting their growth. It is classified as a targeted therapy, focusing on specific molecular changes in cancer cells.

  • Pembrolizumab

    This medication is administered intravenously and is an established treatment in medicine, particularly for various types of cancer, including non-small cell lung cancer. It is used as a first-line treatment for patients with metastatic non-small cell lung cancer with high PD-L1 expression. Pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, enhancing the body's immune response against cancer.

Investigated diseases

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically starts in the tissues of the lungs and can spread to other parts of the body. It progresses through stages, beginning with localized tumors and potentially advancing to more widespread involvement of the lungs and other organs. Symptoms may include a persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary greatly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507776-42-00Protocol codeMK-1084-004Estimated enrolment683 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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