RecruitingCarcinoma, Non-Small-Cell Lung
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)
Eligible age
18+ yrs
Accepts
All genders
Locations
9 states
Healthy volunteers
No
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About this study
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.
Sponsor: Bristol-Myers Squibb
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).
- ✓ For combination arms
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.
- ✕ 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/exclusion criteria apply.
Where it's recruiting
Alaska
Anchorage
Massachusetts
Boston
Michigan
Detroit
Missouri
St Louis
New York
New York
Ohio
Canton
Oregon
Portland
Washington
Seattle
Wisconsin
Milwaukee
Source: ClinicalTrials.gov · NCT06855771 · last updated 2026-09-18