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Study of AMG 193 tablets for patients with advanced non-small cell lung cancer (NSCLC) who have previously received treatment and have MTAP gene deletion

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What is this trial about?

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

This study focuses on people with advanced Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic characteristic called MTAP deletion. This type of lung cancer has already been treated with at least one previous therapy but has continued to progress. The cancer is either spread to other parts of the body (metastatic) or cannot be removed through surgery (unresectable).

The study will test a new medication called AMG 193, which is given as tablets taken by mouth. This research aims to understand how well AMG 193 works and how safe it is for patients at two different dose levels. The study consists of two parts, and doctors will monitor how patients respond to the treatment using special imaging tests like computed tomography (CT) or Magnetic Resonance Imaging (MRI).

During the study, researchers will track various aspects of the treatment's effectiveness, including how many patients' tumors shrink or disappear, how long the treatment benefits last, and how long patients survive without their disease getting worse. They will also collect information about any side effects that occur and measure the amount of medication in patients' bodies. Additionally, patients will complete questionnaires about their symptoms and overall health throughout the study.

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

    Initial assessment

    Your medical history and condition will be reviewed to confirm you have advanced non-small cell lung cancer with MTAP deletion.

    A tissue sample from your previous biopsy will be required for analysis.

    If you have brain metastases, they must be either treated and stable for at least 14 days, or be untreated but smaller than 2 cm and not causing symptoms.

  2. Step 2

    Treatment initiation

    You will receive AMG 193 in tablet form to take by mouth.

    The treatment will be administered at one of two dose levels, which will be determined by your doctor.

    Your response to the treatment will be monitored through regular imaging scans (CT or MRI).

  3. Step 3

    Ongoing monitoring

    Regular assessments will track how your cancer responds to the treatment.

    Your doctor will monitor any side effects that may occur during treatment.

    You will be asked to complete questionnaires about your symptoms and overall health.

    Blood samples will be taken to measure the levels of AMG 193 in your body.

  4. Step 4

    Treatment duration

    The study will continue until December 2028.

    Your participation may end earlier if your disease progresses or if you experience unacceptable side effects.

    Your doctor will regularly assess if continuing the treatment is beneficial for you.

Who can join the trial?

8 criteria

  • You must have confirmed non-small cell lung cancer that has spread to other parts of the body (metastatic) or cannot be surgically removed (unresectable), with a specific genetic feature called MTAP deletion in the tumor tissue
  • You must have previously received at least 1 treatment for your advanced cancer and experienced disease progression or recurrence after that treatment
  • You must have a previously collected tumor tissue sample available for testing
  • Your doctor must determine that your life expectancy is greater than 3 months
  • If you have had cancer spread to the brain (brain metastases), you may participate if:
    • You have received treatment with radiation or surgery that was completed at least 14 days before starting the study, or
    • You have untreated brain metastases that are 2 centimeters or smaller, cause no symptoms, and do not require steroid treatment
    • Both men and women may participate
    • You must be an adult (18 years or older)

Who cannot join the trial?

13 criteria

  • Prior treatment with any MTAP/PRMT5 targeted therapy (substances that affect specific proteins in cancer cells)
  • Active brain metastases (cancer that has spread to the brain) or spinal cord compression that requires treatment
  • History of another type of cancer in the past 3 years, except for successfully treated skin cancer or early-stage cancer
  • Severe heart conditions including: - Heart attack within past 6 months - Unstable angina (chest pain) - Heart failure requiring treatment - Uncontrolled high blood pressure
  • Serious infections requiring intravenous antibiotics
  • Known infection with HIV, active hepatitis B, or active hepatitis C
  • Major surgery within 28 days before starting the study treatment
  • Pregnancy or breastfeeding
  • Any medical condition that could interfere with the study medication absorption
  • Mental health conditions that could affect ability to follow study requirements
  • Use of other experimental drugs within 28 days before starting this study
  • Known allergies to similar medications
  • Abnormal laboratory test results that suggest significant organ dysfunction
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Investigated drugs

AMG 193 is an investigational medication being studied in cancer treatment. It targets specific types of non-small cell lung cancer (NSCLC) that have a particular genetic characteristic - the deletion of an enzyme called methylthioadenosine phosphorylase (MTAP). This medication is being tested in patients who have previously received other treatments for their advanced lung cancer. The trial is evaluating how well the medication works and how safe it is when given to patients at different dose levels.

What is already known about the treatment

AMG 193 - An investigational medication currently being studied in Phase 2 clinical trials for the treatment of advanced Non-Small Cell Lung Cancer (NSCLC) in patients with methylthioadenosine phosphorylase (MTAP) deletion. This experimental drug is being evaluated at two different dose levels to assess its safety, effectiveness, and how the body processes the medication. The clinical trials are designed to test AMG 193 as a monotherapy (used alone) in patients who have previously received other treatments for their cancer. While the exact mechanism of action and administration form are not specified in the available data, the drug is being studied under rigorous clinical trial conditions with both investigator and independent review assessments.

Investigated diseases

Non-Small Cell Lung Cancer - A type of lung cancer that begins in the cells of the lungs and forms a mass of tissue known as a tumor. It develops when healthy cells in the lung tissue begin to grow uncontrollably and abnormally. The disease typically starts in the cells that line the airways of the lungs (bronchi). As the cancer grows, it can spread to nearby tissues and form new tumors. Non-small cell lung cancer accounts for the majority of all lung cancer cases and tends to grow and spread more slowly than small cell lung cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514459-14-00Protocol code20230153Estimated enrolment211 patientsSponsorAmgen Inc.

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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).