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

Last updated: January 30, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

BMS-986504

Clinical Study ID

NCT06855771
CA240-0009
2024-519814-29
U1111-1315-9473
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and efficacy of 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

Inclusion

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 Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: BMS-986504
Phase: 2
Study Start date:
September 09, 2025
Estimated Completion Date:
December 30, 2031

Connect with a study center

  • GenesisCare - Campbelltown

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • Local Institution - 0057

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • Local Institution - 0059

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • GenesisCare - Campbelltown

    Campbelltown 2172586, New South Wales 2155400 2560
    Australia

    Active - Recruiting

  • Chris O'Brien Lifehouse

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Active - Recruiting

  • Local Institution - 0059

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Local Institution - 0058

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Active - Recruiting

  • Local Institution - 0097

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • GenesisCare - St Andrew's

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Active - Recruiting

  • Local Institution - 0039

    Beijing, Beijing 101149
    China

    Site Not Available

  • Local Institution - 0039

    Beijing 1816670, Beijing Municipality 2038349 101149
    China

    Site Not Available

  • Local Institution - 0055

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Local Institution - 0055

    Xiamen 1790645, Fujian 1811017 361003
    China

    Site Not Available

  • Local Institution - 0050

    Nanning, Guangxi 530201
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning 1799869, Guangxi 1809867 530201
    China

    Active - Recruiting

  • Local Institution - 0050

    Nanning 1799869, Guangxi 1809867 530201
    China

    Site Not Available

  • Local Institution - 0043

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Local Institution - 0043

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Site Not Available

  • Local Institution - 0056

    Changchun, Jilin 130000
    China

    Site Not Available

  • Local Institution - 0056

    Changchun 2038180, Jilin 2036500 130000
    China

    Site Not Available

  • Local Institution - 0054

    Jinan, Shandong 250117
    China

    Site Not Available

  • Local Institution - 0044

    Linyi, Shandong 276001
    China

    Site Not Available

  • Local Institution - 0054

    Jinan 1805753, Shandong 1796328 250117
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328 250117
    China

    Active - Recruiting

  • Local Institution - 0044

    Linyi 1803318, Shandong 1796328 276001
    China

    Site Not Available

  • Local Institution - 0049

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Local Institution - 0053

    Linhai, Zhejiang 317000
    China

    Site Not Available

  • Local Institution - 0049

    Hangzhou 1808926, Zhejiang 1784764 310016
    China

    Site Not Available

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

    Hangzhou 1808926, Zhejiang 1784764 310016
    China

    Active - Recruiting

  • Local Institution - 0053

    Linhai 1803422, Zhejiang 1784764 317000
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Linhai 1803422, Zhejiang 1784764 317000
    China

    Active - Recruiting

  • Local Institution - 0045

    Marseille, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Local Institution - 0045

    Marseille 2995469, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Local Institution - 0015

    La Tronche, Isère 38700
    France

    Site Not Available

  • Chu Grenoble Alpes

    La Tronche 3006131, Isère 38700
    France

    Active - Recruiting

  • Local Institution - 0015

    La Tronche 3006131, Isère 38700
    France

    Site Not Available

  • Local Institution - 0012

    Saint-Herblain, Loire-Atlantique 44800
    France

    Site Not Available

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

    Saint-Herblain 2979590, Loire-Atlantique 44800
    France

    Active - Recruiting

  • Local Institution - 0012

    Saint-Herblain 2979590, Loire-Atlantique 44800
    France

    Site Not Available

  • Local Institution - 0095

    Vandoeuvre lès Nancy, Meurthe-et-Moselle 54511
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy 2970797, Meurthe-et-Moselle 54511
    France

    Active - Recruiting

  • Local Institution - 0095

    Vandœuvre-lès-Nancy 2970797, Meurthe-et-Moselle 54511
    France

    Site Not Available

  • Local Institution - 0041

    Bron, Rhône 69677
    France

    Site Not Available

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron 3029931, Rhône 69677
    France

    Active - Recruiting

  • Local Institution - 0041

    Bron 3029931, Rhône 69677
    France

    Site Not Available

  • Local Institution - 0096

    Paris, Île-de-France 75014
    France

    Site Not Available

  • Groupe hospitalier Paris saint Joseph

    Paris 2988507, Île-de-France Region 3012874 75014
    France

    Active - Recruiting

  • Local Institution - 0096

    Paris 2988507, Île-de-France Region 3012874 75014
    France

    Site Not Available

  • Local Institution - 0013

    Paris, 75014
    France

    Site Not Available

  • Local Institution - 0027

    Paris, 75970
    France

    Site Not Available

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris 2988507, 75014
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris 2988507, 75970
    France

    Active - Recruiting

  • Local Institution - 0013

    Paris 2988507, 75014
    France

    Site Not Available

  • Local Institution - 0027

    Paris 2988507, 75970
    France

    Site Not Available

  • Local Institution - 0107

    Paris 2988507, 75248
    France

    Site Not Available

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München 2867713, Bavaria 2951839 81377
    Germany

    Active - Recruiting

  • Local Institution - 0068

    München 2867713, Bavaria 2951839 81377
    Germany

    Site Not Available

  • Local Institution - 0068

    München, Bayern 81377
    Germany

    Site Not Available

  • Local Institution - 0070

    Frankfurt am Main 2925533, Hesse 2905330 60590
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt am Main 2925533, Hesse 2905330 60590
    Germany

    Active - Recruiting

  • Local Institution - 0070

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Local Institution - 0066

    Halle, Sachsen-Anhalt 06120
    Germany

    Site Not Available

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle 2911522, Saxony-Anhalt 2842565 06120
    Germany

    Active - Recruiting

  • Local Institution - 0066

    Halle 2911522, Saxony-Anhalt 2842565 06120
    Germany

    Site Not Available

  • Local Institution - 0067

    Cologne 2886242, 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Cologne 2886242, 50937
    Germany

    Active - Recruiting

  • Local Institution - 0067

    Köln, 50937
    Germany

    Site Not Available

  • Local Institution - 0065

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Local Institution - 0065

    Würzburg 2805615, 97080
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Würzburg 2805615, 97080
    Germany

    Active - Recruiting

  • Local Institution - 0020

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Local Institution - 0026

    Napoli, Campania 80131
    Italy

    Site Not Available

  • AOU della Campania Luigi Vanvitelli

    Napoli 9031661, Campania 3181042 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Napoli 9031661, Campania 3181042 80131
    Italy

    Active - Recruiting

  • Local Institution - 0020

    Napoli 9031661, Campania 3181042 80131
    Italy

    Site Not Available

  • Local Institution - 0026

    Napoli 9031661, Campania 3181042 80131
    Italy

    Site Not Available

  • Local Institution - 0025

    Monza, Lombardia 20900
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza 3172629, Lombardy 3174618 20900
    Italy

    Active - Recruiting

  • Local Institution - 0025

    Monza 3172629, Lombardy 3174618 20900
    Italy

    Site Not Available

  • Local Institution - 0022

    Milan, Milano 20162
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan 3173435, Milano 20162
    Italy

    Active - Recruiting

  • Local Institution - 0022

    Milan 3173435, Milano 20162
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padua 3171728, Veneto 3164604 35128
    Italy

    Active - Recruiting

  • Local Institution - 0024

    Bologna, 40138
    Italy

    Site Not Available

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

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • Local Institution - 0024

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • Local Institution - 0019

    Milan, 20133
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan 3173435, 20133
    Italy

    Active - Recruiting

  • Local Institution - 0019

    Milan 3173435, 20133
    Italy

    Site Not Available

  • Local Institution - 0023

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 0023

    Padua 3171728, 35128
    Italy

    Site Not Available

  • Local Institution - 0092

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Local Institution - 0092

    Kashiwa 1859924, Chiba 2113014 277-8577
    Japan

    Site Not Available

  • Local Institution - 0094

    Sendai, Miyagi 9810914
    Japan

    Site Not Available

  • Local Institution - 0094

    Sendai 2111149, Miyagi 2111888 9810914
    Japan

    Site Not Available

  • Local Institution - 0093

    Hirakata, Osaka 573-1191
    Japan

    Site Not Available

  • Local Institution - 0093

    Hirakata 1862540, Osaka 1853904 573-1191
    Japan

    Site Not Available

  • Local Institution - 0060

    Wieliszew 755886, Masovian Voivodeship 858787 05-135
    Poland

    Site Not Available

  • Mazowiecki Szpital Onkologiczny

    Wieliszew 755886, Masovian Voivodeship 858787 05-135
    Poland

    Active - Recruiting

  • Local Institution - 0060

    Wieliszew, Mazowieckie 05-135
    Poland

    Site Not Available

  • Local Institution - 0064

    Prabuty, Pomorskie 82-550
    Poland

    Site Not Available

  • Local Institution - 0064

    Prabuty 3088161, 82-550
    Poland

    Site Not Available

  • Local Institution - 0029

    Bucharest, București 022338
    Romania

    Site Not Available

  • Local Institution - 0040

    Bucharest, București 020335
    Romania

    Site Not Available

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

    Bucharest 683506, București 683504 022338
    Romania

    Active - Recruiting

  • Local Institution - 0029

    Bucharest 683506, București 683504 022338
    Romania

    Site Not Available

  • Local Institution - 0036

    Florești, Cluj 681291 407280
    Romania

    Site Not Available

  • SC Radiotherapy Center Cluj SRL

    Florești, Cluj 681291 407280
    Romania

    Active - Recruiting

  • Local Institution - 0031

    Craiova, Dolj 200542
    Romania

    Site Not Available

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova 680332, Dolj 679134 200542
    Romania

    Active - Recruiting

  • Local Institution - 0031

    Craiova 680332, Dolj 679134 200542
    Romania

    Site Not Available

  • Local Institution - 0040

    Bucharest 683506, 020335
    Romania

    Site Not Available

  • Local Institution - 0034

    Cluj, 400015
    Romania

    Site Not Available

  • Institutul Oncologic Cluj

    Cluj-Napoca 681290, 400015
    Romania

    Active - Recruiting

  • Local Institution - 0034

    Cluj-Napoca 681290, 400015
    Romania

    Site Not Available

  • Local Institution - 0030

    Iași, 700106
    Romania

    Site Not Available

  • Local Institution - 0032

    Iași, 700483
    Romania

    Site Not Available

  • Institutul Regional de Oncologie

    Iași 675810, 700483
    Romania

    Active - Recruiting

  • Local Institution - 0030

    Iași 675810, 700106
    Romania

    Site Not Available

  • Local Institution - 0032

    Iași 675810, 700483
    Romania

    Site Not Available

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

    Iași 675810, 700106
    Romania

    Active - Recruiting

  • Local Institution - 0074

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Local Institution - 0074

    Barcelona 3128760, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Institut Català d'Oncologia - L'Hospitalet

    Hospitalet, Barcelona [Barcelona] 08907
    Spain

    Active - Recruiting

  • Local Institution - 0073

    Hospitalet, Barcelona [Barcelona] 08907
    Spain

    Site Not Available

  • Local Institution - 0071

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Local Institution - 0076

    Madrid, Madrid, Comunidad De 28046
    Spain

    Site Not Available

  • Local Institution - 0077

    Madrid, Madrid, Comunidad De 28034
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, Madrid, Comunidad de 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, Madrid, Comunidad de 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid 3117735, Madrid, Comunidad de 28034
    Spain

    Active - Recruiting

  • Local Institution - 0071

    Madrid 3117735, Madrid, Comunidad de 28041
    Spain

    Site Not Available

  • Local Institution - 0076

    Madrid 3117735, Madrid, Comunidad de 28046
    Spain

    Site Not Available

  • Local Institution - 0077

    Madrid 3117735, Madrid, Comunidad de 28034
    Spain

    Site Not Available

  • Local Institution - 0075

    Málaga, 29011
    Spain

    Site Not Available

  • H.R.U Málaga - Hospital General

    Málaga 2514256, 29011
    Spain

    Active - Recruiting

  • Local Institution - 0075

    Málaga 2514256, 29011
    Spain

    Site Not Available

  • Local Institution - 0089

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Seville 2510911, 41013
    Spain

    Active - Recruiting

  • Local Institution - 0089

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Local Institution - 0072

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Local Institution - 0072

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0002

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

    Site Not Available

  • Karolinska Universitetssjukhuset Solna

    Solna 2675397, Stockholms Län [se-01] 171 64
    Sweden

    Active - Recruiting

  • Local Institution - 0002

    Solna 2675397, Stockholms Län [se-01] 171 64
    Sweden

    Site Not Available

  • Local Institution - 0003

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

    Site Not Available

  • Local Institution - 0003

    Gothenburg 2711537, Västra Götalands Län [se-14] 413 45
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Gothenburg 2711537, Västra Götalands Län [se-14] 413 45
    Sweden

    Active - Recruiting

  • Local Institution - 0069

    Birmingham, England B15 2TH
    United Kingdom

    Site Not Available

  • Local Institution - 0069

    Birmingham 2655603, England 6269131 B15 2TH
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital Birmingham

    Birmingham 2655603, England 6269131 B15 2TH
    United Kingdom

    Active - Recruiting

  • Local Institution - 0008

    London, London, City Of w1g 6ad
    United Kingdom

    Site Not Available

  • Sarah Cannon Research Institute UK

    London 2643743, London, City of w1g 6ad
    United Kingdom

    Active - Recruiting

  • Local Institution - 0004

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Local Institution - 0004

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Site Not Available

  • Alaska Oncology and Hematology

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Local Institution - 0088

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Alaska Oncology and Hematology

    Anchorage 5879400, Alaska 5879092 99508
    United States

    Active - Recruiting

  • Local Institution - 0099

    Boise, Idaho 83712
    United States

    Site Not Available

  • Local Institution - 0099

    Boise 5586437, Idaho 5596512 83712
    United States

    Site Not Available

  • Local Institution - 0090

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Local Institution - 0090

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Local Institution - 0100

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Local Institution - 0100

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Local Institution - 0104

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Local Institution - 0104

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Local Institution - 0018

    New York, New York 10065
    United States

    Site Not Available

  • Local Institution - 0079

    Shirley, New York 11967
    United States

    Site Not Available

  • Local Institution - 0018

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Local Institution - 0079

    Shirley 5138022, New York 5128638 11967
    United States

    Site Not Available

  • Local Institution - 0091

    Canton, Ohio 44718
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton 5149222, Ohio 5165418 44718
    United States

    Active - Recruiting

  • Local Institution - 0091

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • Local Institution - 0098

    Portland, Oregon 97225
    United States

    Site Not Available

  • Local Institution - 0103

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0098

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • Local Institution - 0103

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland 5746545, Oregon 5744337 97213
    United States

    Active - Recruiting

  • Local Institution - 0102

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0078

    Seattle, Washington 98109
    United States

    Site Not Available

  • Fred Hutchison Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

  • Local Institution - 0078

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

  • Local Institution - 0084

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Local Institution - 0084

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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