RecruitingPhase 2NCT06855771

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

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

Sponsor

Bristol-Myers Squibb

Enrollment

182 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests BMS-986504, a new oral targeted therapy, for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic deletion called homozygous MTAP deletion, whose disease has progressed after prior treatments. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with non-small cell lung cancer confirmed by biopsy - Your tumor has a specific genetic change called homozygous MTAP deletion - Your cancer has spread and is not curable, and it has progressed after prior treatment - You have at least one measurable tumor on imaging - You are in good health (ECOG score 0–1) - You can swallow tablets whole **You may NOT be eligible if:** - You have active cancer in the brain or cancer that has spread to the lining of the brain - You have stomach or gut problems that prevent you from absorbing oral medications - You have previously received a PRMT5 or MAT2A inhibitor - You have a known severe allergy to the study drug or its ingredients Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986504

Specified dose on specified days

DRUGIzalontamab Brengitecan

Specified dose on specified days

Locations(67)

Local Institution - 0088

Anchorage, Alaska, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Gabrail Cancer Center

Canton, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Fred Hutchison Cancer Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

GenesisCare - Campbelltown

Campbelltown, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Local Institution - 0097

Adelaide, South Australia, Australia

Beijing Chest Hospital,Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated hospital of Xiamen University

Xiamen, Fujian, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

LinYi Cancer Hospital

Linyi, Shandong, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

Chu Grenoble Alpes

La Tronche, Isère, France

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

Saint-Herblain, Loire-Atlantique, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

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

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, Rhône, France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, France

Institut Curie

Paris, France

Hôpital Tenon

Paris, France

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region, France

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bavaria, Germany

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Hesse, Germany

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

AOU della Campania Luigi Vanvitelli

Naples, Campania, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano, Italy

Istituto Oncologico Veneto IRCCS

Padova, Veneto, Italy

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

Bologna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Mazowiecki Szpital Onkologiczny

Wieliszew, Masovian Voivodeship, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o.

Prabuty, Poland

Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

Bucharest, Bucharest, Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Centrul de Diagnostic si Tratament Provita

Bucharest, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

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

Iași, Romania

Institutul Regional de Oncologie

Iași, Romania

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Institut Català d'Oncologia - L'Hospitalet

Hospitalet, Barcelona [Barcelona], Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, Spain

H.R.U Málaga - Hospital General

Málaga, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01], Sweden

Sahlgrenska Universitetssjukhuset

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

Queen Elizabeth Hospital Birmingham

Birmingham, England, United Kingdom

Sarah Cannon Research Institute UK

London, London, City of, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

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NCT06855771

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