Actively Recruiting
A Phase 2 Study Evaluating Safety and Efficacy of Navlimetostat (BMS-986504) Monotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer With Homozygous MTAP Deletion After Prior Therapies
Led by Bristol-Myers Squibb · Updated on 2026-05-26
130
Participants Needed
70
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety and effectiveness of Navlimetostat (BMS-986504) taken alone in adults with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) who have a specific genetic change called homozygous MTAP deletion and whose cancer has progressed after previous treatments. The study is a Phase 2, randomized, open-label trial sponsored by Bristol-Myers Squibb. Participants will receive one of two doses of Navlimetostat as oral tablets, taken on specified days. The study compares these two dosing regimens to evaluate their impact on cancer response and progression. The trial includes a treatment period followed by monitoring for outcomes including response rates, disease control, survival, and safety over several years after treatment. During the study, participants will undergo regular assessments such as scans to measure tumor size using RECIST v1.1 criteria, symptom and quality-of-life questionnaires, and monitoring for side effects and adverse events. The main measure is the number of participants achieving an objective tumor response. Follow-up will continue for up to three years after the last dose, with additional evaluations of disease control, survival, and health-related quality of life.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of NSCLC with homozygous MTAP deletion confirmed from tumor tissue
- Advanced or metastatic NSCLC not suitable for curative treatment after progression on prior therapies
- At least one measurable tumor lesion according to RECIST v1.1
- Documented disease progression on or after the most recent treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least 18 years old or legal age of consent at the study location
- Ability to swallow tablets whole without chewing or crushing
You will not qualify if you...
- Active brain metastases or carcinomatous meningitis
- History of gastrointestinal disease or conditions likely to affect absorption of the study medication or inability to swallow oral drugs
- Prior treatment with PRMT5 or MAT2A inhibitors
- Known severe allergy to the study drug or its ingredients
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years or until disease progression or discontinuation
Participants receive specified doses of the study drug BMS-986504 according to their assigned treatment arm.
Repeated visits for dosing and assessments as per protocol
Duration - Up to 28 days after the last dose of study treatment
Participants are monitored for safety, disease status, and quality of life after treatment ends.
Several visits for safety and health assessments
Trial Site Locations
Total: 70 locations
1
Alaska Oncology and Hematology
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Local Institution - 0099
Boise, Idaho, United States, 83712
Not Yet Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
5
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Local Institution - 0079
Shirley, New York, United States, 11967
Not Yet Recruiting
8
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
9
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
10
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
11
Fred Hutchison Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
12
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
13
GenesisCare - Campbelltown
Campbelltown, New South Wales, Australia, 2560
Actively Recruiting
14
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
15
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
16
GenesisCare - St Andrew's
Adelaide, South Australia, Australia, 5000
Actively Recruiting
17
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
18
The First Affiliated hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
19
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China, 530201
Actively Recruiting
20
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
21
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
22
LinYi Cancer Hospital
Linyi, Shandong, China, 276001
Actively Recruiting
23
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
24
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China, 317000
Actively Recruiting
25
Local Institution - 0045
Marseille, Bouches-du-Rhône, France, 13385
Not Yet Recruiting
26
Chu Grenoble Alpes
La Tronche, Isère, France, 38700
Actively Recruiting
27
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-Atlantique, France, 44800
Actively Recruiting
28
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
Actively Recruiting
29
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, Rhône, France, 69677
Actively Recruiting
30
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, France, 75014
Actively Recruiting
31
Institut Curie
Paris, France, 75248
Actively Recruiting
32
Hôpital Tenon
Paris, France, 75970
Actively Recruiting
33
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, France, 75014
Actively Recruiting
34
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, Germany, 81377
Actively Recruiting
35
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
36
Krankenhaus Martha-Maria Halle-Dölau
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
37
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
38
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97080
Actively Recruiting
39
AOU della Campania Luigi Vanvitelli
Naples, Campania, Italy, 80131
Actively Recruiting
40
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, Italy, 80131
Actively Recruiting
41
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy, 20900
Actively Recruiting
42
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy, 20162
Actively Recruiting
43
Istituto Oncologico Veneto IRCCS
Padova, Veneto, Italy, 35128
Actively Recruiting
44
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
45
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
46
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
47
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 9810914
Actively Recruiting
48
Kansai Medical University Hospital
Hirakata, Osaka, Japan, 573-1191
Actively Recruiting
49
Mazowiecki Szpital Onkologiczny
Wieliszew, Masovian Voivodeship, Poland, 05-135
Actively Recruiting
50
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, Poland, 82-550
Actively Recruiting
51
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, Bucharest, Romania, 022338
Actively Recruiting
52
SC Radiotherapy Center Cluj SRL
Florești, Cluj, Romania, 407280
Actively Recruiting
53
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania, 200542
Actively Recruiting
54
Centrul de Diagnostic si Tratament Provita
Bucharest, Romania, 020335
Actively Recruiting
55
Institutul Oncologic Cluj
Cluj-Napoca, Romania, 400015
Actively Recruiting
56
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, Romania, 700106
Actively Recruiting
57
Institutul Regional de Oncologie
Iași, Romania, 700483
Actively Recruiting
58
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
59
Institut Català d'Oncologia - L'Hospitalet
Hospitalet, Barcelona [Barcelona], Spain, 08907
Actively Recruiting
60
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
61
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain, 28041
Actively Recruiting
62
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain, 28046
Actively Recruiting
63
H.R.U Málaga - Hospital General
Málaga, Spain, 29011
Actively Recruiting
64
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
65
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
66
Karolinska Universitetssjukhuset Solna
Solna, Stockholms Län [se-01], Sweden, 171 64
Actively Recruiting
67
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
Actively Recruiting
68
Queen Elizabeth Hospital Birmingham
Birmingham, England, United Kingdom, B15 2TH
Actively Recruiting
69
Sarah Cannon Research Institute UK
London, London, City of, United Kingdom, w1g 6ad
Actively Recruiting
70
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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