Tests navlimetostat alone or with izalontamab brengitecan in lung cancer
Tests navlimetostat alone or combined in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Goteborg and Solna, SwedenSee the 2 sites
- Phase
- Phase 2
Where in Sweden
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborg, SwedenTaking people
- Karolinska University HospitalSolna, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06855771EU 2024-519814-29-00
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of Navlimetostat (BMS-986504) Monotherapy and 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
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.
Inclusion: 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; Participants must have documented evidence of EGFR status; Participants with EGFR mutant or wild type NSCLC are allowed.
Exclusion: Prior treatment with a PRMT5 or MAT2A inhibitor; 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; Known severe hypersensitivity to study treatment and/or any of its excipients; For combination arms; 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; Active brain metastases or carcinomatous meningitis; Other protocol-defined inclusion/exclusion criteria apply.