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NCT Number: NCT06855771

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)

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GenesisCare - Campbelltown, Campbelltown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
  • Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
  • At least 1 measurable lesion as per RECIST v1.1.
  • Documented radiographic disease progression on or after the most recent line of treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
  • Capability to swallow tablets intact (without chewing or crushing).

Exclusion criteria

  • Active brain metastases or carcinomatous meningitis.
  • History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • Prior treatment with a PRMT5 or MAT2A inhibitor.
  • Known severe hypersensitivity to study treatment and/or any of its excipients.
  • Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986504

Drug

Specified dose on specified days

Other names: MRTX1719, Navlimetostat

Primary outcomes

  1. Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to 3 years after the last participant's last dose of study treatment

    OR is defined as confirmed complete response (CR) or partial response (PR)

Secondary outcomes

  1. Number of participants who achieve disease control (DC) as assessed by RECIST v1.1

    Time frame: Up to 3 years after the last participant's last dose of study treatment

    DC is defined as Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)

  2. Number of participants who achieve clinical benefit (CB) as assessed by RECIST v1.1

    Time frame: Up to 3 years after the last participant's last dose of study treatment

    CB is defined as BOR of confirmed CR, confirmed PR, or SD for at least 6 months after start of treatment

  3. Duration of response (DOR) as assessed by RECIST v1.1

    Time frame: Up to 3 years after the last participant's last dose of study treatment

    DOR is defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first)

  4. Progression-free survival (PFS) as assessed by RECIST v1.1

    Time frame: Up to 3 years after the last participant's last dose of study treatment

    PFS is defined as the time between randomization and the date of disease progression or death from any cause (whichever occurs first)

  5. Time to objective response (TTOR) as assessed by RECIST v1.1

    Time frame: Up to 3 years after the last participant's last dose of study treatment

    TTOR is defined as the time between randomization to the date of the first documentation of objective tumor response (CR or PR)

  6. Number of participants with adverse events (AE)

    Time frame: Up to 28 days after the last dose of study treatment

  7. Number of participants with Serious AEs (SAEs)

    Time frame: Up to 28 days after the last dose of study treatment

  8. Number of participants with AEs leading to dose interruption, reduction, or discontinuation

    Time frame: Up to 28 days after the last dose of study treatment

  9. Number of deaths

    Time frame: Up to 28 days after the last dose of study treatment

  10. Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1

    Time frame: Up to 3 years after the last participant's last dose of study treatment

  11. Overall Survival (OS)

    Time frame: Up to 3 years after the last participant's last dose of study treatment

    OS is defined as the time between the randomization/the start of treatment to death due to any cause

  12. Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score

    Time frame: Up to 28 days after the last dose of study treatment

  13. Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core Function Global Health Status functional scale score

    Time frame: Up to 28 days after the last dose of study treatment

  14. Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score

    Time frame: Up to 28 days after the last dose of study treatment

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of Navlimetostat (BMS-986504) Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Mar 4, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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