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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)

StatusRecruiting

PhasePhase 2

SponsorBristol-Myers Squibb

Started2025-09-09

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary endpoints added 1 → 9 primary endpoints

See other at-risk trials from Bristol-Myers Squibb

Amendment history

2026-09-19

Primary endpoint(s) modified1 to 9 entries

WasNumber of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

NowNumber of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Number of participants with AEs leading to death, Number of participants with AEs leading to study treatment discontinuation, Number of participants with Serious AEs (SAEs), Number of participants with adverse events (AE), Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria, Number of participants with laboratory abnormalities, Number of participants with treatment related AEs, Number of participants with treatment related SAEs

Enrollment increased: 130 → 182 participants

Trial arms changed: 2 → 4

Trial sites reduced: 70 → 67 locations

Interventions modified

2026-06-09

Study Status, Contacts/Locations v35

Study sites70 entries, revised

~~GenesisCare~~Local Institution - ~~St Andrew's~~0097

2026-05-21

Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v34

Study sites71→70

Study title+16 characters

A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non [...]

2026-04-29

Study Status, Contacts/Locations v33

Study sites71 entries, revised

~~Local~~Beijing ~~Institution~~Chest -Hospital,Capital ~~0039~~Medical University

2026-04-21

Study Status, Contacts/Locations v32

Study sites71 entries, revised

~~Local~~LinYi ~~Institution~~Cancer ~~- 0044~~Hospital ~~Local~~Institut ~~Institution - 0107~~Curie

Show 31 earlier versions

2026-03-23

Study Status, Contacts/Locations v31

Study sites71 entries, revised

~~Local~~National ~~Institution~~Cancer -Center ~~0092~~Hospital East ~~Local~~Sendai ~~Institution~~Kousei -Hospital Kansai ~~0094 Local~~Medical ~~Institution~~University ~~- 0093~~Hospital

2026-03-10

Study Status, Contacts/Locations v30

Study sites71 entries, revised

~~Local~~Centrul ~~Institution~~de -Diagnostic ~~0040~~si Tratament Provita

2026-02-20

Study Status, Contacts/Locations v29

Study sites71 entries, revised

~~Local~~Szpital ~~Institution~~Specjalistyczny -w ~~0064~~Prabutach Spolka z o.o.

2026-02-10

Study Status, Contacts/Locations v28

Study sites71 entries, revised

~~Local~~The ~~Institution~~First -Affiliated ~~0055~~hospital of Xiamen University ~~Local~~The ~~Institution~~First -Affiliated ~~0043~~Hospital of Nanchang University

2026-01-30

Study Status, Contacts/Locations, IPDSharing v27

Study sites71 entries, revised

~~Local~~AOU ~~Institution~~della -Campania ~~0026~~Luigi Vanvitelli

2026-01-22

Study Status, Contacts/Locations v26

Study sites71 entries, revised

~~Local~~Institut ~~Institution~~Català d'Oncologia - ~~0073~~L'Hospitalet

2026-01-20

Study Status, Contacts/Locations v25

Study sites71 entries, revised

~~Local~~Oregon ~~Institution~~Health -and ~~0103~~Science University ~~Local~~Sir ~~Institution~~Run -Run ~~0049~~Shaw Hospital of Zhejiang University School of Medicine ~~Local~~Taizhou ~~Institution~~Hospital -of ~~0053~~Zhejiang Province

2026-01-08

Study Status, Contacts/Locations v24

Study sites71 entries, revised

~~Local~~Queen ~~Institution~~Elizabeth -Hospital ~~0069~~Birmingham

2026-01-02

Study Status, Contacts/Locations v23

Study sites71 entries, revised

~~Local~~Washington ~~Institution~~University School of Medicine Guangxi Medical University Affiliated Tumor Hospital Shandong Cancer Hospital Istituto Oncologico Veneto IRCCS IRCCS Azienda Ospedaliero-Universitaria ~~0104~~di Bologna, Policlinico di Sant'Orsola ~~Local~~Institutul ~~Institution~~Oncologic -Bucuresti ~~0050~~"Prof. Dr. Alexandru Trestioreanu" ~~Local~~SC ~~Institution~~Radiotherapy -Center ~~0054~~Cluj SRL ~~Local~~S.C. ~~Institution~~Centrul -de ~~0024~~Oncologie Euroclinic S.R.L. ~~Local~~Institutul ~~Institution~~Regional -de ~~0023 Local Institution - 0029 Local Institution - 0036 Local Institution - 0030 Local Institution - 0032~~ [...]

2025-12-04

Study Status, Contacts/Locations v22

Study sites71 entries, revised

~~Local~~Institutul ~~Institution~~Oncologic ~~- 0034~~Cluj

2025-12-02

Study Status, Contacts/Locations v21

Study sites71 entries, revised

~~Local~~Fred ~~Institution~~Hutchison -Cancer ~~0078~~Center ~~Local~~Centrul ~~Institution~~de -Oncologie ~~0031~~"Sfântul Nectarie"

2025-11-24

Study Status, Contacts/Locations v20

Study sites71 entries, revised

~~Local~~ASST ~~Institution~~Grande -Ospedale ~~0022~~Metropolitano Niguarda

2025-11-18

Study Status, Contacts/Locations v19

Study sites71 entries, revised

~~Local~~Dana-Farber ~~Institution~~Cancer -Institute Fondazione ~~0090 Local~~IRCCS ~~Institution~~Istituto -Nazionale ~~0019~~dei Tumori

2025-11-12

Study Status, Contacts/Locations v18

Study sites71 entries, revised

~~Local~~Providence ~~Institution~~Portland -Medical ~~0098~~Center ~~Local~~Hospital ~~Institution~~Universitario -La ~~0076~~Paz

2025-10-31

Study Status, Contacts/Locations v17

Study sites70→71

2025-10-09

Study Status, Contacts/Locations v16

Study sites70 entries, revised

~~Local~~Gabrail ~~Institution~~Cancer Center Hospices Civils de Lyon - ~~0091~~Hopital Louis Pradel ~~Local~~Hospital ~~Institution~~Universitari -i ~~0041 Local~~Politecnic ~~Institution~~La ~~- 0072~~Fe

2025-10-07

Study Status, Contacts/Locations v15

Study sites70 entries, revised

~~Local~~Chris ~~Institution~~O'Brien ~~- 0059~~Lifehouse

2025-10-03

Study Status, Eligibility, Contacts/Locations v14

Eligibility criteria-2 characters

Inclusion Criteria: Histologically confirmed diagnosis of NSCLC and homozygous [...] ets intact (without chewing or crushing). Exclusion Criteria: Active brain metastases or carcinomatous meningitis. Histor [...]

Study sites70 entries, revised

~~Local~~Freeman ~~Institution - 0004~~Hospital

2025-10-01

Study Status, Contacts/Locations v13

Start dateestimated 2025-09-15→confirmed 2025-09-09

Study sites70 entries, revised

~~Local~~Memorial ~~Institution~~Sloan Kettering Cancer Center Chu Grenoble Alpes Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes Centre Hospitalier Régional Universitaire de Nancy - ~~0018~~Hôpitaux de Brabois ~~Local~~Hopitaux ~~Institution~~Universitaires Paris Centre-Hopital Cochin Hôpital Tenon Groupe hospitalier Paris saint Joseph Krankenhaus Martha-Maria Halle-Dölau Universitaetsklinikum Koeln Universitaetsklinikum Wuerzburg Istituto Nazionale Tumori IRCCS Fondazione Pascale Mazowiecki Szpital Onkologiczny Hospital Universitario Ra [...] - ~~0015~~Hospital General ~~Local~~Hospital ~~Institution~~Universitario -Virge [...] [...]

2025-08-26

Study Identification, Study Status, Contacts/Locations v12

Start date2025-08-06→2025-09-15

Study sites71→70

Study title+16 characters

[...] small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

2025-07-07

Study Status, Outcome Measures, Contacts/Locations v11

Start date2025-05-30→2025-08-06

Study sites70→71

Secondary endpointsdetails revised at 1 of 14 entries

2025-05-12

Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v10

Trial statusNot Yet Recruiting→Recruiting

Study sitesdetails revised at 70 of 70 sites

2025-04-22

Study Status, Contacts/Locations v9

Study sites65→70

2025-04-08

Study Status, Contacts/Locations, References v8

Study sites30→65

2025-04-01

Study Status, Contacts/Locations, References v7

Study sites26→30

2025-03-27

Study Status, Contacts/Locations v6

Study sites25→26

2025-03-24

Study Status, Contacts/Locations v5

Study sites22→25

2025-03-20

Study Status, Contacts/Locations v4

Study sites10→22

2025-03-14

Study Status, Contacts/Locations v3

Study sites9→10

2025-03-12

Study Status, Contacts/Locations v2

Study sites8→9

2025-03-10

Study Status, Contacts/Locations, References v1

Study sites3→8

2025-02-27

Original filing

Bristol-Myers Squibb

311 trials monitored

See 15 trials at risk

4,033 trials monitored

See 210 trials at risk

Non-Small Cell Lung Cancer (NSCLC)

2,914 trials monitored

See 156 trials at risk

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.

Trial Details

NCT Number	NCT06855771
Lead Sponsor	Bristol-Myers Squibb
Conditions	Carcinoma, Non-Small-Cell Lung
Enrollment	182 participants
Start Date	2025-09-09
Primary Completion	2028-12-29 (estimated)
Study Completion	2031-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-09-18