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Carcinoma, Non-Small-Cell LungPhase 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 Phase 2 study testing BMS-986504 and Izalontamab Brengitecan in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 67 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
BMS-986504 and Izalontamab Brengitecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
67 sitesin 12 countries
Study dates
9 Sep 2025to 30 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • Capability to swallow tablets intact (without chewing or crushing).
  • For combination arms
  • Participants must have documented evidence of EGFR status.
  • Participants with EGFR mutant or wild type NSCLC are allowed.

Who cannot join

  • 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.
  • For combination arms
  • Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab.
  • Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

67 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

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

67 sites in 12 countries

United States10 sites, 9 recruiting

  • Local Institution - 0088

    Anchorage, Alaska, 99508

    Completed

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Pasi Janne, Site 0090, 617-632-6036

    Recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Nashat Gabrail, Site 0091, 330-417-8231

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Hirva Mamdani, Site 0100, 909-525-0093

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Jonathan Thompson, Site 0084, 414-805-4600

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Kathryn Arbour, Site 0018, 646-608-3792

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Rachel Sanborn, Site 0098, 503-215-5696

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Jeremy Cetnar, Site 0103, 503-494-3840

    Recruiting

  • Fred Hutchison Cancer Center

    Seattle, Washington, 98109

    Lei Deng, Site 0078, 206-606-4801

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Anjali Rohatgi, Site 0104, 314-747-1171

    Recruiting

Other trials in United States

China8 sites, 8 recruiting

  • Beijing Chest Hospital,Capital Medical University

    Beijing, Beijing Municipality, 101149

    Zhe Liu, Site 0039, 010-8909303

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Enguo Chen, Site 0049, 13588706779

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Ligang Xing, Site 0054, 86-15553181309

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang, 317000

    Dongqing LV, Site 0053, 13867622009

    Recruiting

  • LinYi Cancer Hospital

    Linyi, Shandong, 276001

    Jianhua Shi, Site 0044, +8615963998868

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Longhua Sun, Site 0043, 8613698091288

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530201

    Wenhua Zhao, Site 0050, 13878873120

    Recruiting

  • The First Affiliated hospital of Xiamen University

    Xiamen, Fujian, 361003

    Feng Ye, Site 0055, 8613860458889

    Recruiting

Other trials in China

France8 sites, 8 recruiting

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron, Rhône, 69677

    Michael Duruisseaux, Site 0041, 33427857700

    Recruiting

  • Chu Grenoble Alpes

    La Tronche, Isère, 38700

    Denis Moro-Sibilot, Site 0015, 33476765467

    Recruiting

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75014

    Marie Wislez, Site 0013, 33158413091

    Recruiting

  • Institut Curie

    Paris, 75248

    nicolas girard, Site 0107, +33624456290

    Recruiting

  • Hôpital Tenon

    Paris, 75970

    Jacques Cadranel, Site 0027, 33156016531

    Recruiting

  • Groupe hospitalier Paris saint Joseph

    Paris, Île-de-France Region, 75014

    Carole Helissey-Danis, Site 0096, 33330143985319

    Recruiting

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

    Saint-Herblain, Loire-Atlantique, 44800

    Elvire Pons-Tostivint, Site 0012, +33676133810

    Recruiting

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

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

    Bertrand Mennecier, Site 0095, 33383154653

    Recruiting

Other trials in France

Spain8 sites, 8 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

    Enriqueta Felip Font, Site 0074, 34932746077

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    Hospitalet, Barcelona [Barcelona], 08907

    Ernest Nadal Alforja, Site 0073, 34932607283

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

    Maria Eugenia Olmedo Garcia, Site 0077, 34913368263

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

    Luis Paz-Ares Rodriguez, Site 0071, +34913908546

    Recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046

    Javier de Castro Carpeno, Site 0076, 34917277516

    Recruiting

  • H.R.U Málaga - Hospital General

    Málaga, 29011

    Manuel Cobo-Dols, Site 0075, 00349422033350000

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Reyes Bernabe Caro, Site 0089, 34955015273

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Oscar Juan Vidal, Site 0072, 34961245877

    Recruiting

Other trials in Spain

Italy7 sites, 7 recruiting

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

    Bologna, 40138

    Francesco Gelsomino, Site 0024, +390512142203

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162

    Giulio Cerea, Site 0022, 390264442291

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Claudia Proto, Site 0019, 390223903829

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, 20900

    Diego Cortinovis, Site 0025, 390392333683

    Recruiting

  • AOU della Campania Luigi Vanvitelli

    Naples, Campania, 80131

    Carminia Maria Della Corte, Site 0026, 3929160541

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, Campania, 80131

    Alessandro Morabito, Site 0020, 390817770291

    Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

    Giulia Pasello, Site 0023, 39498215620

    Recruiting

Other trials in Italy

Romania7 sites, 7 recruiting

  • Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

    Bucharest, Bucharest, 022338

    Aurelia Alexandru, Site 0029, 40723289606

    Recruiting

  • Centrul de Diagnostic si Tratament Provita

    Bucharest, 020335

    Mircea Dediu, Site 0040, 0040744432443

    Recruiting

  • Institutul Oncologic Cluj

    Cluj-Napoca, 400015

    Tudor Ciuleanu, Site 0034, 40745646368

    Recruiting

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200542

    Michael Schenker, Site 0031, 40727774974

    Recruiting

  • SC Radiotherapy Center Cluj SRL

    Florești, Cluj, 407280

    Andrei Ungureanu, Site 0036, 40742206212

    Recruiting

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

    Iași, 700106

    Constantin Volovat, Site 0030, 40746110096

    Recruiting

  • Institutul Regional de Oncologie

    Iași, 700483

    Dana Clement, Site 0032, 40744692062

    Recruiting

Other trials in Romania

Germany5 sites, 5 recruiting

  • Universitaetsklinikum Koeln

    Cologne, 50937

    Juergen Wolf, Site 0067, +4922147889050

    Recruiting

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt am Main, Hesse, 60590

    Fabian Acker, Site 0070, 0000

    Recruiting

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, Saxony-Anhalt, 06120

    Miriam Moeller, Site 0066, 00493455591440

    Recruiting

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, Bavaria, 81377

    Diego Kauffmann-Guerrero, Site 0068, 4989440052590

    Recruiting

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

    Elisabeth Goebeler, Site 0065, 4993120140155

    Recruiting

Other trials in Germany

Australia4 sites, 3 recruiting

  • Local Institution - 0097

    Adelaide, South Australia, 5000

    Completed

  • GenesisCare - Campbelltown

    Campbelltown, New South Wales, 2560

    Jessica Smith, Site 0057, +61 2 4632 5500

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

    Steven Kao, Site 0059, +61 2 85140594

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Wen Xu, Site 0058, (+61) 731762111

    Recruiting

Other trials in Australia

Japan3 sites, 3 recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Takayasu Kurata, Site 0093, 81728042503

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Hibiki Udagawa, Site 0092, 81471331111

    Recruiting

  • Sendai Kousei Hospital

    Sendai, Miyagi, 9810914

    Shunichi Sugawara, Site 0094, 81227288000

    Recruiting

Other trials in Japan

United Kingdom3 sites, 3 recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, England, B15 2TH

    Gary Middleton, Site 0069, +44 121 3718783

    Recruiting

  • Sarah Cannon Research Institute UK

    London, London, City of, w1g 6ad

    Elisa Fontana, Site 0008, +44 (0) 203 219 5234

    Recruiting

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

    Alastair Greystoke, Site 0004, +44 (0)191 213 8450

    Recruiting

Other trials in United Kingdom

Poland2 sites, 2 recruiting

  • Szpital Specjalistyczny w Prabutach Spolka z o.o.

    Prabuty, 82-550

    Anna Lowczak, Site 0064, +48503022396

    Recruiting

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, Masovian Voivodeship, 05-135

    Renata Biernacka, Site 0060, 509120229

    Recruiting

Other trials in Poland

Sweden2 sites, 2 recruiting

  • Sahlgrenska Universitetssjukhuset

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

    Andreas Hallqvist, Site 0003, +46735-985411

    Recruiting

  • Karolinska Universitetssjukhuset Solna

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

    Luigi DePetris, Site 0002, 45 08-123 79517

    Recruiting

Other trials in Sweden

About this study

Official title: 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

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.

Being tested
BMS-986504, Izalontamab Brengitecan
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986504Drug

    Also called MRTX1719, Navlimetostat

    Specified dose on specified days

  • Izalontamab BrengitecanDrug

    Also called BMS-986507, BL-BO1D1, Iza-bren

    Specified dose on specified days

Study groups in NCT06855771
Study groupRoleWhat they receive
Arm A: BMS-986504 Dose 1ExperimentalNot described
Receives: Drug: BMS-986504
Arm B: BMS-986504 Dose 2ExperimentalNot described
Receives: Drug: BMS-986504
Arm C: BMS-986504 Dose 1 + Izalontamab BrengitecanExperimentalNot described
Receives: Drug: BMS-986504; Drug: Izalontamab Brengitecan
Arm D: BMS-986504 Dose 2 + Izalontamab BrengitecanExperimentalNot described
Receives: Drug: BMS-986504; Drug: Izalontamab Brengitecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

  2. Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria

    Arm C and Arm D

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

  3. Number of participants with adverse events (AE)

    Arm C and Arm D

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

  4. Number of participants with Serious AEs (SAEs)

    Arm C and Arm D

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

  5. Number of participants with treatment related AEs

    Arm C and Arm D

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

  6. Number of participants with treatment related SAEs

    Arm C and Arm D

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

  7. Number of participants with AEs leading to study treatment discontinuation

    Arm C and Arm D

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

  8. Number of participants with AEs leading to death

    Arm C and Arm D

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

  9. Number of participants with laboratory abnormalities

    Arm C and Arm D

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

Secondary outcomes (14)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  6. Number of participants with adverse events (AE)

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

  7. Number of participants with Serious AEs (SAEs)

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

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

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

  9. Number of deaths

    Measured: 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

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

  11. Overall Survival (OS)

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

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

  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

    Measured: 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 score

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start9 Sep 2025
  3. Primary completion29 Dec 2028 (estimated)
  4. Study completion30 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855771
Sponsor's protocol ID
CA240-0009
Other IDs
2024-519814-29, U1111-1315-9473
Status last verified
Sep 2026
First submitted
27 Feb 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986504 and Izalontamab Brengitecan in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 67 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, China, France, Spain, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06855771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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