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NCT06855771PHASE2Recruiting

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)

Bristol-Myers Squibb

Start Date

9/9/2025

Completion Date

12/30/2031

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BMS-986504

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Conditions

Carcinoma, Non-Small-Cell Lung

Locations

Alaska Oncology and Hematology

Anchorage, Alaska 99508

United States

Local Institution - 0099

Boise, Idaho 83712

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Local Institution - 0079

Shirley, New York 11967

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Fred Hutchison Cancer Center

Seattle, Washington 98109

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

GenesisCare - Campbelltown

Campbelltown, New South Wales 2560

Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales 2050

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Local Institution - 0097

Adelaide, South Australia 5000

Australia

Beijing Chest Hospital,Capital Medical University

Beijing, Beijing Municipality 101149

China

The First Affiliated hospital of Xiamen University

Xiamen, Fujian 361003

China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi 530201

China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

LinYi Cancer Hospital

Linyi, Shandong 276001

China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang 310016

China

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang 317000

China

Local Institution - 0045

Marseille, Bouches-du-Rhône 13385

France

Chu Grenoble Alpes

La Tronche, Isère 38700

France

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

Saint-Herblain, Loire-Atlantique 44800

France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

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

France

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, Rhône 69677

France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, 75014

France

Institut Curie

Paris, 75248

France

Hôpital Tenon

Paris, 75970

France

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region 75014

France

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bavaria 81377

Germany

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Hesse 60590

Germany

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt 06120

Germany

Universitaetsklinikum Koeln

Cologne, 50937

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97080

Germany

AOU della Campania Luigi Vanvitelli

Naples, Campania 80131

Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania 80131

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy 20900

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano 20162

Italy

Istituto Oncologico Veneto IRCCS

Padova, Veneto 35128

Italy

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

Bologna, 40138

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Sendai Kousei Hospital

Sendai, Miyagi 9810914

Japan

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

Mazowiecki Szpital Onkologiczny

Wieliszew, Masovian Voivodeship 05-135

Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o.

Prabuty, 82-550

Poland

Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

Bucharest, Bucharest 022338

Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj 407280

Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj 200542

Romania

Centrul de Diagnostic si Tratament Provita

Bucharest, 020335

Romania

Institutul Oncologic Cluj

Cluj-Napoca, 400015

Romania

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

Iași, 700106

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Institut Català d'Oncologia - L'Hospitalet

Hospitalet, Barcelona [Barcelona] 08907

Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de 28041

Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de 28046

Spain

H.R.U Málaga - Hospital General

Málaga, 29011

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01] 171 64

Sweden

Sahlgrenska Universitetssjukhuset

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

Sweden

Queen Elizabeth Hospital Birmingham

Birmingham, England B15 2TH

United Kingdom

Sarah Cannon Research Institute UK

London, London, City of w1g 6ad

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom