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Study Comparing Adagrasib and Docetaxel for Patients with Advanced 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 Advanced Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called the KRAS G12C mutation. The study is comparing two treatments for this condition. One treatment is an investigational drug called Adagrasib, also known by its code name MRTX849, which is taken as a film-coated tablet. The other treatment is a medication called Docetaxel, which is given as an infusion into a vein.

The purpose of the study is to evaluate how effective Adagrasib is compared to Docetaxel in patients who have already received treatment for their lung cancer. Participants in the study will be randomly assigned to receive either Adagrasib or Docetaxel. The study will monitor the participants over time to see how their cancer responds to the treatment and to check for any side effects. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, researchers will collect information on how long patients live without their cancer getting worse, as well as overall survival rates and how patients feel during the treatment. The study will also look at the safety of the treatments by tracking any adverse events or side effects. This information will help determine the best treatment option for patients with this type of lung cancer.

The research process

The trial runs in 7 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, a diagnosis of advanced non-small cell lung cancer with a specific mutation (KRAS G12C) is confirmed.

    Eligibility is determined based on previous treatment history and readiness to receive docetaxel.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the investigational agent MRTX849 or docetaxel.

    This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    If assigned to MRTX849, the medication is taken orally in the form of film-coated tablets.

    If assigned to docetaxel, the medication is administered intravenously as a solution for infusion.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the progression of the disease and the response to treatment.

    Assessments include measuring progression-free survival, overall survival, and response rates.

  5. Step 5

    Safety evaluations

    Safety is evaluated by monitoring adverse events, laboratory abnormalities, and any discontinuation of treatment due to adverse effects.

    Patient-reported outcomes are collected using specific questionnaires to assess symptoms and quality of life.

  6. Step 6

    Crossover option

    Participants initially receiving docetaxel may have the option to switch to MRTX849 if disease progression is observed.

    Eligibility for crossover is based on specific criteria, including performance status and disease progression.

  7. Step 7

    Completion of study

    The study is estimated to conclude by the end of 2024.

    Final assessments will be conducted to evaluate the overall outcomes and effectiveness of the treatments.

Who can join the trial?

6 criteria

  • Must have a confirmed diagnosis of **Non-Small Cell Lung Cancer (NSCLC)** with a specific change in the KRAS gene called **G12C mutation**. This means that tests have shown the presence of this type of lung cancer and the specific genetic change.
  • Must be eligible to receive treatment with a drug called **docetaxel**. This means the patient can safely take this medication as part of their treatment plan.
  • For those switching treatments, there must be evidence of disease progression according to specific criteria called **RECIST 1.1** after receiving docetaxel. This means the cancer has continued to grow or spread despite treatment.
  • For those switching treatments, the patient must have an **ECOG performance status** of 0 to 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations but still able to care for themselves.
  • Both male and female patients are eligible to participate.
  • Participants should not be part of a vulnerable population, meaning they should be able to give informed consent and participate fully in the study.

Who cannot join the trial?

4 criteria

  • Patients who have not been previously treated for their lung cancer.
  • Patients without the specific genetic change called KRAS G12C mutation in their cancer.
  • Patients with a type of lung cancer other than Non-Small Cell Lung Cancer.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • MRTX849

    is an investigational medication being studied for its effectiveness in treating non-small cell lung cancer (NSCLC) in patients who have a specific genetic mutation known as KRAS G12C. This medication is being tested to see if it can help control the cancer in patients who have already received other treatments.

  • Docetaxel

    is a chemotherapy drug that is commonly used to treat various types of cancer, including non-small cell lung cancer. It works by interfering with the growth and spread of cancer cells in the body. In this study, docetaxel is being used as a comparison to evaluate the effectiveness of the investigational medication MRTX849.

What is already known about the treatment

  • MRTX849

    This investigational medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer (NSCLC) with a specific genetic mutation known as KRAS G12C. It is not yet approved for general medical use, but it is being evaluated for its potential benefits in this specific type of cancer. MRTX849 works by selectively inhibiting the KRAS G12C protein, which is involved in the growth and survival of cancer cells. It belongs to a class of drugs known as targeted cancer therapies, which aim to interfere with specific molecules involved in tumor growth.

  • Docetaxel

    This medication is administered intravenously and is an established treatment option for various types of cancer, including non-small cell lung cancer. It is widely recognized in medical literature and is used to treat patients who have previously undergone other treatments. Docetaxel works by disrupting the normal function of microtubules in cells, which are essential for cell division, thereby inhibiting the growth of cancer cells. It is classified as a chemotherapy drug, specifically a taxane, which targets rapidly dividing cancer cells.

Investigated diseases

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its advanced stage, meaning it has spread beyond the lungs to other parts of the body. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors, which can interfere with normal lung function and spread to other organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507263-19-00Protocol code849-012Estimated enrolment647 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).