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 now · Phase 2
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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.
Key facts
- Study ID
- NCT06855771
- Run by
- Bristol-Myers Squibb
- People needed
- 130
- Starts
- 2025-09-09
- Expected to finish
- 2031-12-30
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- Chu Grenoble Alpes — La Tronche, Isère, France (enrolling)
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois — Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France (enrolling)
- Alaska Oncology and Hematology — Anchorage, Alaska, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes — Saint-Herblain, Loire-Atlantique, France (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
- Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
- Oregon Health and Science University — Portland, Oregon, United States (enrolling)
- Fred Hutchison Cancer Center — Seattle, Washington, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- GenesisCare - Campbelltown — Campbelltown, New South Wales, Australia (enrolling)
- Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
- Gabrail Cancer Center — Canton, Ohio, United States (enrolling)
- Beijing Chest Hospital,Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated hospital of Xiamen University — Xiamen, Fujian, China (enrolling)
- Guangxi Medical University Affiliated Tumor Hospital — Nanning, Guangxi, China (enrolling)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
- Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
- LinYi Cancer Hospital — Linyi, Shandong, China (enrolling)
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
- Taizhou Hospital of Zhejiang Province — Linhai, Zhejiang, China (enrolling)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
- Hospices Civils de Lyon - Hopital Louis Pradel — Bron, Rhône, France (enrolling)
Full record on ClinicalTrials.gov
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