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Study of MK-1084 plus durvalumab versus placebo plus durvalumab in patients with locally advanced KRAS G12C‑mutant non‑small cell lung cancer after chemoradiotherapy

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What is this trial about?

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

The study focuses on people with locally advanced, unresected stage II‑III non‑small cell lung cancer that carries a KRAS G12C mutation. Locally advanced means the cancer has spread within the chest but cannot be removed by surgery; unresected indicates surgery is not possible or chosen. The trial compares an oral tablet of MK-1084 taken together with an intravenous infusion of durvalumab against a placebo tablet plus the same infusion of durvalumab. The purpose is to see whether adding MK-1084 can keep the cancer from growing or spreading for a longer time.

Participants will receive the assigned tablet daily and the infusion every few weeks, with regular clinic visits for safety checks, blood tests and imaging scans such as CT scans to look for changes in tumor size. The study will continue until the disease gets worse, a participant stops treatment, or the trial ends. Researchers will record how long the cancer stays stable (progression‑free survival), overall survival, side effects, and quality‑of‑life questionnaires.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First treatment visit

    After enrollment you will attend the first clinic visit where a study coordinator will confirm eligibility and explain the schedule.

    You will receive an intravenous infusion of durvalumab at a dose of 1500 mg. the medicine is given through a vein over a period of time as directed by the medical team.

    At the same visit you will be given either the study drug mk-1084 in the form of a film‑coated tablet or a matching placebo tablet. the exact amount of the tablet is defined by the study protocol.

  2. Step 2

    Daily oral tablet administration

    Each day you will take the assigned tablet by mouth with water, following the same time each day.

    The tablet is designed to be swallowed whole and should not be crushed or chewed.

    If you are assigned the placebo, the tablet will contain no active medication but will look identical to the study drug.

  3. Step 3

    Regular infusion visits

    You will return to the clinic for additional durvalumab infusions according to the study schedule, typically every few weeks.

    Each infusion will again be 1500 mg given by intravenous route.

    The clinic staff will monitor you during the infusion for any immediate reactions.

  4. Step 4

    Clinical monitoring and assessments

    At each infusion visit you will have blood tests taken to check how your body is responding to the treatment.

    Imaging studies such as scans may be performed at predefined intervals to evaluate the status of the lung cancer.

    You will complete quality‑of‑life questionnaires that ask about symptoms and daily functioning.

  5. Step 5

    Reporting side effects

    You are asked to inform the study team of any new symptoms, discomfort, or changes in health as soon as they occur.

    Common side effects may include fatigue, nausea, or reactions at the infusion site, but you will be instructed on how to recognize and report them.

  6. Step 6

    Continuation or discontinuation of treatment

    You will continue taking the oral tablet daily and receiving the scheduled infusions until the study ends, the disease shows progression, or a serious adverse event requires stopping the medication.

    The decision to stop treatment will be made by the investigators based on safety and disease status.

Who can join the trial?

8 criteria

  • Must have a diagnosis made by looking at cells or tissue under a microscope that shows locally advanced, unresected Stage II (node‑positive) to Stage III non‑small cell lung cancer (NSCLC) that is mostly the nonsquamous type.
  • Must have finished a full course of platinum‑based concurrent chemoradiotherapy (CCRT) (a treatment that combines chemotherapy with radiation) before joining the study, and the cancer must not have gotten worse.
  • Must have provided a tumor sample for testing in a central laboratory to check for the KRAS G12C mutation, the PD‑L1 level, and other research markers.
  • The tumor sample must show that the KRAS G12C mutation is present and that a result for PD‑L1 can be measured.
  • If you have HIV infection, the virus must be well‑controlled with antiretroviral therapy (ART) (medicines that keep HIV at low levels).
  • If you test positive for hepatitis B surface antigen (HBsAg), you must have an undetectable amount of hepatitis B virus (HBV) in your blood and be taking hepatitis B antiviral medicine.
  • If you have a history of hepatitis C virus (HCV) infection, you must have an undetectable amount of HCV in your blood.
  • Must weigh at least 35 kilograms (about 77 pounds).

Who cannot join the trial?

12 criteria

  • Has a diagnosis of small cell lung cancer or tumors that contain small cell components (a fast‑growing type of lung cancer).
  • Has an active infection that requires systemic therapy (medicines that treat the whole body).
  • Has a history of a stem cell transplant or a solid organ transplant (such as kidney or liver transplant).
  • Has not fully recovered from major surgery or still has surgical complications.
  • Has a gastrointestinal disorder that affects absorption of medicine or cannot swallow oral medication (problems with the stomach or intestines).
  • Has active inflammatory bowel disease (like Crohn’s disease or ulcerative colitis) that needs immunosuppressive medication, or has a clear past history of this disease.
  • Has uncontrolled or serious cardiovascular disease (heart problems) or cerebrovascular disease (blood‑vessel problems in the brain).
  • Is HIV-infected and has a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease (specific conditions linked to weakened immunity).
  • Has received any prior treatment for NSCLC (non‑small cell lung cancer) other than the standard definitive CCRT (combined chemoradiation therapy).
  • Has another malignancy (cancer) that is progressing or needed active treatment within the past 3 years.
  • Has an active autoimmune disease that required systemic treatment (medicines affecting the whole body) in the past 2 years.
  • Has a past or current (non‑infectious) pneumonitis/interstitial lung disease that required or now requires steroids (anti‑inflammatory medicines).
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Investigated drugs

  • MK-1084

    is an experimental oral medication that comes as a film‑coated tablet. In this study participants take the tablet by mouth. The drug is being tested to see if it can help slow the growth of lung cancer that has a specific KRAS mutation. Researchers are looking at whether adding MK-1084 to standard treatment improves the time patients live without their disease getting worse.

  • Durvalumab

    is a medicine that is given through an IV infusion. It belongs to a class of treatments called immunotherapy, which help the body’s immune system recognize and attack cancer cells. In this trial, all participants receive durvalumab, and the study compares how well it works when combined with the experimental drug MK-1084 versus when it is given with a placebo.

What is already known about the treatment

  • MK-1084

    This medication is taken by mouth as a film‑coated tablet. It is still investigational and is being studied in clinical trials for lung cancer that carries a KRAS G12C mutation. The drug works by attaching to the KRAS G12C protein and keeping it in an inactive state, which can slow the growth of cancer cells. It belongs to the class of small‑molecule KRAS G12C inhibitors.

  • Durvalumab

    This medication is given by intravenous infusion, usually at a dose of 1500 mg. It is an approved cancer treatment that is used for non‑small cell lung cancer after chemoradiotherapy. Durvalumab is a monoclonal antibody that blocks the PD‑L1 protein, helping the immune system recognize and attack cancer cells. It is classified as an immune‑checkpoint inhibitor.

Investigated diseases

Non‑small cell lung cancer, KRAS G12C‑mutated, locally advanced, unresectable (stage II–III) - This disease is a type of lung cancer that begins in the cells lining the airways and carries a specific KRAS G12C genetic change. It grows larger within the lung and may invade nearby structures such as blood vessels and lymph nodes. Because it is classified as locally advanced, the tumor has spread beyond its original site but has not yet formed distant metastases. The cancer is considered unresectable when surgery cannot remove it due to its size, location, or the patient’s medical condition. Over time, the tumor can continue to enlarge and infiltrate surrounding tissues, potentially leading to further spread within the chest.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522038-29-00Protocol codeMK-1084-015Estimated enrolment346 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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