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)

NCT06855771 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: CA240-00092024-519814-29U1111-1315-9473
• Study Type: interventional
• Target: 130
• Locations: 12 countries
• Sites: 70

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (14)

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

  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

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

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

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

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

  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

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

Study Arms (2)

Arm A: BMS-986504 Dose 1

EXPERIMENTAL

Drug: BMS-986504

Arm B: BMS-986504 Dose 2

EXPERIMENTAL

Drug: BMS-986504

Interventions

BMS-986504 DRUG

Specified dose on specified days

Also known as: MRTX1719, Navlimetostat

Arm A: BMS-986504 Dose 1; Arm B: BMS-986504 Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (70)

Alaska Oncology and Hematology

Anchorage, Alaska, 99508, United States

RECRUITING

Local Institution - 0099

Boise, Idaho, 83712, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Local Institution - 0079

Shirley, New York, 11967, United States

NOT YET RECRUITING

Gabrail Cancer Center

Canton, Ohio, 44718, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Fred Hutchison Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

GenesisCare - Campbelltown

Campbelltown, New South Wales, 2560, Australia

RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Local Institution - 0097

Adelaide, South Australia, 5000, Australia

COMPLETED

Beijing Chest Hospital,Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

The First Affiliated hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530201, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

LinYi Cancer Hospital

Linyi, Shandong, 276001, China

RECRUITING

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, 317000, China

RECRUITING

Local Institution - 0045

Marseille, Bouches-du-Rhône, 13385, France

NOT YET RECRUITING

Chu Grenoble Alpes

La Tronche, Isère, 38700, France

RECRUITING

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

Saint-Herblain, Loire-Atlantique, 44800, France

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

RECRUITING

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, Rhône, 69677, France

RECRUITING

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, 75014, France

RECRUITING

Institut Curie

Paris, 75248, France

RECRUITING

Hôpital Tenon

Paris, 75970, France

RECRUITING

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region, 75014, France

RECRUITING

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bavaria, 81377, Germany

RECRUITING

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, 50937, Germany

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

RECRUITING

AOU della Campania Luigi Vanvitelli

Naples, Campania, 80131, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania, 80131, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano, 20162, Italy

RECRUITING

Istituto Oncologico Veneto IRCCS

Padova, Veneto, 35128, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Sendai Kousei Hospital

Sendai, Miyagi, 9810914, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Mazowiecki Szpital Onkologiczny

Wieliszew, Masovian Voivodeship, 05-135, Poland

RECRUITING

Szpital Specjalistyczny w Prabutach Spolka z o.o.

Prabuty, 82-550, Poland

RECRUITING

Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

Bucharest, Bucharest, 022338, Romania

RECRUITING

SC Radiotherapy Center Cluj SRL

Florești, Cluj, 407280, Romania

RECRUITING

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, 200542, Romania

RECRUITING

Centrul de Diagnostic si Tratament Provita

Bucharest, 020335, Romania

RECRUITING

Institutul Oncologic Cluj

Cluj-Napoca, 400015, Romania

RECRUITING

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, 700106, Romania

RECRUITING

Institutul Regional de Oncologie

Iași, 700483, Romania

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Institut Català d'Oncologia - L'Hospitalet

Hospitalet, Barcelona [Barcelona], 08907, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, 28046, Spain

RECRUITING

H.R.U Málaga - Hospital General

Málaga, 29011, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01], 171 64, Sweden

RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

RECRUITING

Queen Elizabeth Hospital Birmingham

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

Sarah Cannon Research Institute UK

London, London, City of, w1g 6ad, United Kingdom

RECRUITING

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): December 30, 2031
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

AU (4); US (12); DE (5); ES (8); GB (3); CN (8); PL (2); RO (7); FR (9); IT (7); SE (2); JP (3)