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Study of BMS-986504 for patients with advanced or metastatic non-small cell lung cancer with homozygous MTAP deletion who have previously received treatment

Verified siteInvestigationalNo placebo
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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 patients with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) who have already received previous treatments. The study specifically targets patients whose cancer has a particular genetic feature called homozygous MTAP deletion, which means certain genes in the cancer cells are missing. The treatment being tested is BMS-986504 (also known as MRTX1719), which is given as a film-coated tablet that patients take by mouth.

The main purpose of this research is to evaluate how well different doses of BMS-986504 work in treating this specific type of lung cancer. The medication will be given to patients whose cancer has continued to grow or spread despite previous treatments. This is an open-label study, which means both doctors and patients will know which treatment is being given.

During the study, patients will take the medication and have their cancer monitored regularly to see how it responds to the treatment. Doctors will track if the tumors shrink, stay the same size, or grow. They will also monitor how patients feel and any side effects they may experience. The study will look at various aspects of the treatment's effectiveness, including how long the cancer stays controlled and how long patients survive after starting the treatment.

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 evaluation

    Your eligibility for the study will be confirmed based on a documented diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC)

    A test will confirm the presence of homozygous MTAP deletion in your tumor tissue

    Your current health status will be evaluated using the ECOG performance scale, which must be 0-1

    At least one measurable tumor lesion must be identified through imaging

  2. Step 2

    Treatment administration

    You will receive MRTX1719 in the form of film-coated tablets

    The medication will be taken by mouth

    Your ability to swallow tablets will be confirmed before starting treatment

  3. Step 3

    Monitoring and assessments

    Regular imaging scans will track changes in your tumor using standardized criteria (RECIST v1.1)

    Your cancer-related symptoms will be evaluated using specific questionnaires

    Your quality of life will be assessed throughout the study

    Any side effects will be monitored and documented

  4. Step 4

    Study duration

    The study is planned to run from July 2025 to December 2031

    Your participation duration will depend on how your condition responds to the treatment

    Regular assessments will continue throughout your participation in the study

Who can join the trial?

9 criteria

  • Must have confirmed non-small cell lung cancer (a type of lung cancer) with a specific genetic change called homozygous MTAP deletion found in tumor tissue
  • Must have advanced or spreading cancer that cannot be cured with current treatments and has gotten worse after previous therapies
  • Must have at least one tumor that can be measured using special imaging techniques
  • Must show evidence that the disease has gotten worse on recent scans after the latest treatment
  • Must have good physical ability to perform daily activities (ECOG score of 0-1, meaning able to do light work and most daily activities)
  • Must be at least 18 years old when signing the consent form
  • Must be able to swallow medications
  • Both men and women may participate
  • Must be able to provide informed consent to participate in the study

Who cannot join the trial?

13 criteria

  • History of hypersensitivity (severe allergic reactions) to the study medications or similar compounds
  • Active brain metastases (cancer that has spread to the brain) that are not treated or stable
  • Significant heart problems including:
    • Heart attack within the last 6 months
    • Unstable heart disease
    • Irregular heart rhythm requiring medication
    • Severe liver problems or abnormal liver function tests
    • Severe kidney problems or abnormal kidney function tests
    • Active infections requiring systemic treatment (medications that affect the whole body)
    • Other active cancers within the past 2 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
    • Participation in other clinical trials within 30 days before starting this study
    • Any condition that, in the investigator's opinion, would interfere with the study procedures or results
    • Pregnant or breastfeeding women
    • Unable or unwilling to follow contraception requirements during the study period
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Investigated drugs

  • MRTX1719

    is an experimental oral medication taken as a film‑coated tablet. In this study it is being evaluated as a new treatment option for people with advanced non‑small cell lung cancer. The drug is designed to target specific cancer‑related processes, and researchers are watching how safe it is and whether it can shrink tumors in participants who have already tried other therapies.

  • Navlimetostat (BMS986504)

    is the main investigational therapy being tested in this trial. It is given by mouth as a single drug (monotherapy) to patients whose lung cancer has a particular genetic change called a homozygous MTAP deletion. The study aims to see if Navlimetostat can safely control the disease and produce measurable tumor responses after patients have progressed on prior treatments.

What is already known about the treatment

BMS-986504 - An investigational drug being studied in clinical trials for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC), specifically in patients with homozygous MTAP deletion who have progressed after previous treatments. This medication is currently in Phase 2 clinical trials, being administered as monotherapy, though the specific form of administration is not disclosed in the available data. The drug represents a targeted therapeutic approach for a specific genetic alteration (MTAP deletion) in lung cancer patients, making it part of the emerging field of precision medicine in oncology. While the exact molecular mechanism of action is not publicly available, the primary goal of the treatment is to evaluate objective response rates at different dose levels in patients with this specific genetic profile.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the large cells of the lung, including both squamous and non-squamous cells. It typically develops slowly and spreads to other parts of the body through the blood or lymph system. The disease often begins in the cells that line the bronchi and parts of the lung such as the bronchioles or alveoli. As the disease advances or becomes metastatic, cancer cells spread beyond the lungs to nearby lymph nodes or other organs. This form of lung cancer is distinguished from small cell lung cancer by the size and appearance of the cancer cells when viewed under a microscope.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519814-29-00Protocol codeCA240-0009Estimated enrolment130 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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