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Study of Adagrasib Dosing in Patients with Previously Treated Non-Small Cell 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 clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called the KRAS G12C mutation. The trial is testing a medication called Adagrasib, which is taken as a film-coated tablet. Adagrasib is also known by its code name, MRTX849. The purpose of the study is to evaluate how effective two different dosing regimens of Adagrasib are for patients who have already received certain treatments for their cancer.

Participants in the study will receive one of two dosing regimens of Adagrasib. One group will take 600 mg of Adagrasib twice a day without regard to food, while the other group will take 400 mg twice a day with food. The study will monitor how well the cancer responds to these treatments and will also look at the overall survival of the participants, which means the length of time they live after starting the treatment. Additionally, the study will assess how long the treatment keeps the cancer from getting worse and how long any positive response to the treatment lasts.

The trial will also focus on the safety of Adagrasib by observing any side effects that occur during the study. Participants will report any symptoms they experience while taking the medication. The study will continue until 2027, allowing researchers to gather comprehensive data on the effectiveness and safety of Adagrasib for treating NSCLC with the KRAS G12C mutation.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. This means you will either receive one of two different dosing regimens of the medication adagrasib.

    The study is designed to evaluate the effectiveness of these dosing regimens in treating non-small cell lung cancer with a specific mutation called KRAS G12C.

  2. Step 2

    Medication administration

    If you are in the first group, you will take adagrasib as a 600 mg dose twice a day, without regard to food.

    If you are in the second group, you will take adagrasib as a 400 mg dose twice a day, with food.

    The medication is provided in the form of a film-coated tablet, which you will take orally.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess how your body is responding to the treatment.

    You will be asked to report any symptoms or side effects you experience during the study period.

  4. Step 4

    End of treatment

    The study will continue until the estimated end date in May 2027, or until you and your doctor decide it is best to stop the treatment.

    After the last dose of adagrasib, you will have a follow-up period of 28 days to monitor any lasting effects of the treatment.

Who can join the trial?

4 criteria

  • Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
  • Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
  • Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
  • Have recovered from their prior treatment and blood tests are within a safe range.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with non-small cell lung cancer cannot participate.
  • Patients without the KRAS G12C mutation in their cancer cells are excluded. This is a specific change in the cancer's genetic material.
  • Patients who have not received prior treatment with a platinum-based regimen are excluded. This refers to a type of chemotherapy that includes drugs containing the metal platinum.
  • Patients who have not received immune checkpoint inhibitor therapy are excluded. This is a treatment that helps the immune system recognize and attack cancer cells.
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Investigated drugs

Adagrasib is a medication being studied for its potential to treat non-small cell lung cancer, specifically in patients who have a mutation known as KRAS G12C. This medication works by targeting and blocking the activity of the KRAS G12C protein, which is involved in the growth and spread of cancer cells. By inhibiting this protein, adagrasib aims to slow down or stop the progression of the cancer. The study is exploring how effective adagrasib is when taken in different ways, either with or without food, to find the best approach for patients who have already received other cancer treatments, such as chemotherapy and immune therapy.

What is already known about the treatment

Adagrasib – Adagrasib is a medication taken orally, meaning it is swallowed in pill form. It 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 who have already undergone certain treatments. The main purpose of adagrasib is to block the activity of a specific protein that helps cancer cells grow, which is known as the KRAS G12C protein. This medication belongs to a class of drugs called targeted therapies, which are designed to attack cancer cells more precisely than traditional chemotherapy.

Investigated diseases

Non-small cell lung cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and may spread to other parts of the body, a process known as metastasis. NSCLC often grows and spreads more slowly than small cell lung cancer, another major type of lung cancer. The progression of NSCLC can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The disease is often diagnosed at an advanced stage due to the subtlety of early symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503523-25-00Protocol code849-021Estimated enrolment389 patientsSponsorMirati Therapeutics Inc.

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).