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)
Recruiting · NCT06855771 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 10 US states.
- Alaska Oncology and Hematology - Anchorage, Alaska, United States
- Local Institution - 0099 - Boise, Idaho, 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
- Local Institution - 0079 - Shirley, 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
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola - Bologna, Italy
- Centrul de Diagnostic si Tratament Provita - Bucharest, Romania
- Institutul Oncologic Cluj - Cluj-Napoca, Romania
- Universitaetsklinikum Koeln - Cologne, Germany
- S.C. Centrul de Oncologie Euroclinic S.R.L. - Iași, Romania
- Institutul Regional de Oncologie - Iași, Romania
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan, Italy
- H.R.U Málaga - Hospital General - Málaga, Spain
- Freeman Hospital - Newcastle upon Tyne, United Kingdom
- Hopitaux Universitaires Paris Centre-Hopital Cochin - Paris, France
- Institut Curie - Paris, France
- Hôpital Tenon - Paris, France
- Szpital Specjalistyczny w Prabutach Spolka z o.o. - Prabuty, Poland
- Hospital Universitario Virgen Del Rocio - Seville, Spain
- Hospital Universitari i Politecnic La Fe - Valencia, Spain
- Universitaetsklinikum Wuerzburg - Würzburg, Germany
- Hospital Universitari Vall d'Hebron - Barcelona, Barcelona [Barcelona], Spain
- Institut Català d'Oncologia - L'Hospitalet - Hospitalet, Barcelona [Barcelona], Spain
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen - München, Bavaria, Germany
- Beijing Chest Hospital,Capital Medical University - Beijing, Beijing Municipality, China
- Local Institution - 0045 - Marseille, Bouches-du-Rhône, France
- Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu" - Bucharest, Bucharest, Romania
- AOU della Campania Luigi Vanvitelli - Naples, Campania, Italy
- Istituto Nazionale Tumori IRCCS Fondazione Pascale - Naples, Campania, Italy
- National Cancer Center Hospital East - Kashiwa, Chiba, Japan
- SC Radiotherapy Center Cluj SRL - Florești, Cluj, Romania
- Centrul de Oncologie "Sfântul Nectarie" - Craiova, Dolj, Romania
- Queen Elizabeth Hospital Birmingham - Birmingham, England, United Kingdom
- The First Affiliated hospital of Xiamen University - Xiamen, Fujian, China
- Guangxi Medical University Affiliated Tumor Hospital - Nanning, Guangxi, China
- Universitätsklinikum Frankfurt Goethe-Universität - Frankfurt am Main, Hesse, Germany
- Chu Grenoble Alpes - La Tronche, Isère, France
- The First Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China
- Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes - Saint-Herblain, Loire-Atlantique, France
- Fondazione IRCCS San Gerardo dei Tintori - Monza, Lombardy, Italy
- Sarah Cannon Research Institute UK - London, London, City of, United Kingdom
- 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
- Mazowiecki Szpital Onkologiczny - Wieliszew, Masovian Voivodeship, Poland
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois - Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
- ASST Grande Ospedale Metropolitano Niguarda - Milan, Milano, Italy
- Sendai Kousei Hospital - Sendai, Miyagi, Japan
- GenesisCare - Campbelltown - Campbelltown, New South Wales, Australia
- Chris O'Brien Lifehouse - Camperdown, New South Wales, Australia
- Kansai Medical University Hospital - Hirakata, Osaka, Japan
- Princess Alexandra Hospital - Woolloongabba, Queensland, Australia
- Hospices Civils de Lyon - Hopital Louis Pradel - Bron, Rhône, France
Showing 60 of 70 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →