RecruitingInterventionalPhase 2

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

NCT ID: NCT06855771Sponsor: Bristol-Myers SquibbLast updated: 2026-06-10

Summary

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.

Arms & interventions

DrugBMS-986504
Specified dose on specified days

Outcome measures

Primary

Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
OR is defined as confirmed complete response (CR) or partial response (PR)
Time frame: Up to 3 years after the last participant's last dose of study treatment

Secondary

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
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
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
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
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
Number of participants with adverse events (AE)
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with Serious AEs (SAEs)
Time frame: Up to 28 days after the last dose of study treatment
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
Number of deaths
Time frame: Up to 28 days after the last dose of study treatment
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
Overall Survival (OS)
Time frame: Up to 3 years after the last participant's last dose of study treatment
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
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
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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (12)

Alaska Oncology and Hematology

Anchorage, Alaska, 99508

Recruiting

Steven Liu, Site 0088 · Contact

907-257-9851

Local Institution - 0099

Boise, Idaho, 83712

Not Yet Recruiting

Site 0099 · Contact

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Pasi Janne, Site 0090 · Contact

617-632-6036

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

Hirva Mamdani, Site 0100 · Contact

909-525-0093

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting

Anjali Rohatgi, Site 0104 · Contact

314-747-1171

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Kathryn Arbour, Site 0018 · Contact

646-608-3792

Local Institution - 0079

Shirley, New York, 11967

Not Yet Recruiting

Site 0079 · Contact

Gabrail Cancer Center

Canton, Ohio, 44718

Recruiting

Nashat Gabrail, Site 0091 · Contact

330-417-8231

Providence Portland Medical Center

Portland, Oregon, 97213

Recruiting

Rachel Sanborn, Site 0098 · Contact

503-215-5696

Oregon Health and Science University

Portland, Oregon, 97239

Recruiting

Jeremy Cetnar, Site 0103 · Contact

503-494-3840

Fred Hutchison Cancer Center

Seattle, Washington, 98109

Recruiting

Lei Deng, Site 0078 · Contact

206-606-4801

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting

Jonathan Thompson, Site 0084 · Contact

920-202-1555