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RecruitingPHASE2INTERVENTIONAL

A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

This research study, called MountainTAP-9, is looking into a new treatment called Navlimetostat (BMS-986504) for people with advanced or metastatic non-small cell lung cancer. This specific type of lung cancer must have a genetic change called a 'homozygous MTAP deletion' and have worsened after standard treatments. The main goals are to find out if the new medicine is safe, what side effects it might cause, and how well it works to control the cancer. This is a Phase 2 study, meaning it's still in the earlier stages of testing in a smaller group of patients.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Bristol-Myers Squibb
Enrolment target
130
Start
09 Sep 2025
Estimated completion
30 Dec 2031

What is this study about?

This study is exploring a new treatment for a specific group of people living with lung cancer. It focuses on non-small cell lung cancer (NSCLC) that has spread to other parts of the body (advanced or metastatic) and has a particular genetic change called a 'homozygous MTAP deletion'. This type of cancer has already been treated with other medicines, but these treatments are no longer working.

The new medicine being tested is called Navlimetostat (BMS-986504). Researchers want to understand if this medicine can help control the cancer, how safe it is, and what side effects people might experience. They'll be giving the medicine on its own, without other cancer treatments at the same time.

Studies like this are crucial because they help us find new ways to treat cancers that have become resistant to current therapies. By focusing on a specific genetic change, scientists hope to develop targeted treatments that are more effective for certain patients.

Key takeaways

  • New medicine called Navlimetostat for advanced lung cancer.
  • Specifically for non-small cell lung cancer with a 'homozygous MTAP deletion'.
  • For patients whose cancer has progressed after other treatments.
  • Aims to check safety and how well the medicine works.
  • This is a Phase 2 clinical trial, an earlier stage of testing.

Who may be eligible?

To join this study, you must have advanced non-small cell lung cancer that has spread and has a specific genetic change called a 'homozygous MTAP deletion' in your tumour. Your cancer also needs to have worsened after you've had other treatments. You must be at least 18 years old and generally well enough to take part, with a good level of physical activity.

There are also some reasons why you might not be able to join. For example, if you have active brain tumours, certain tummy or bowel conditions that might affect how you absorb medicines, or if you've already had a similar type of experimental drug (PRMT5 or MAT2A inhibitor). Your study doctor will check if you fit all the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have advanced Non-Small Cell Lung Cancer that has spread?
  2. Has your cancer been tested and shown to have a 'homozygous MTAP deletion'?
  3. Has your cancer gotten worse after previous treatments?
  4. Are you generally well enough for daily activities? (Performance status 0-1)
  5. Are you able to swallow tablets whole?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be taking an investigational medication, Navlimetostat, which is given as tablets you swallow. You would have regular visits to the hospital or clinic for assessments. These will include blood tests, scans (like CT scans) to check your cancer, and check-ups with the study team to monitor your health and any side effects. You'll need to be able to swallow tablets whole. The total duration of your participation would depend on how you respond to the treatment and the study plan, but you will be monitored regularly throughout.

Potential risks and benefits

You might not directly benefit from taking part in this study, but your involvement could help researchers learn more about this specific type of lung cancer and potentially lead to new treatments for future patients. All medicines carry risks, and Navlimetostat may cause side effects, some of which could be serious or unexpected. The study team will explain these in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (70)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alaska Oncology and Hematology
    Verified postcode
    Anchorage, United States· Recruiting
  • Local Institution - 0099
    Verified postcode
    Boise, United States· Not yet recruiting
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • Karmanos Cancer Institute
    Verified postcode
    Detroit, United States· Recruiting
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • Local Institution - 0079
    Verified postcode
    Shirley, United States· Not yet recruiting
  • Gabrail Cancer Center
    Verified postcode
    Canton, United States· Recruiting
  • Providence Portland Medical Center
    Verified postcode
    Portland, United States· Recruiting
  • Oregon Health and Science University
    Verified postcode
    Portland, United States· Recruiting
  • Fred Hutchison Cancer Center
    Verified postcode
    Seattle, United States· Recruiting
  • Medical College of Wisconsin
    Verified postcode
    Milwaukee, United States· Recruiting

Common questions

What is 'homozygous MTAP deletion'?

It's a specific genetic change in your lung cancer cells that researchers are targeting with this new medicine.

Will I still receive my usual cancer treatment?

No, if you join this study, you will receive only the experimental medicine, Navlimetostat, as your cancer treatment.

What is a 'Phase 2' study?

It means the medicine has shown some promise in earlier tests and is now being given to a larger group of patients to confirm its safety and effectiveness.

How can I find out if I have an 'MTAP deletion'?

Your doctors would need to test a sample of your tumour tissue to see if this genetic change is present.

What are the common side effects of Navlimetostat?

The study aims to find this out, but like all medicines, it may cause side effects. The study team will review these with you.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Navlimetostat (BMS-986504) in Participants With P…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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