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)
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.
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Checked against the public recordLast updated Sep 18, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: BMS-986504; Drug: Izalontamab Brengitecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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).
- For combination arms 1. Participants must have documented evidence of EGFR status. 2. Participants with EGFR mutant or wild type NSCLC are allowed.
- 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.
- For combination arms a. Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab.
- Other protocol-defined inclusion/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local Institution - 0088Anchorage, Alaska
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Karmanos Cancer InstituteDetroit, Michigan
- Washington University School of MedicineSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Gabrail Cancer CenterCanton, Ohio
- Providence Portland Medical CenterPortland, Oregon
- Oregon Health and Science UniversityPortland, Oregon
- Fred Hutchison Cancer CenterSeattle, Washington
- Medical College of WisconsinMilwaukee, Wisconsin
- GenesisCare - CampbelltownCampbelltown, New South Wales
- Chris O'Brien LifehouseCamperdown, New South Wales
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 18, 2026. Always confirm current availability with the study team.