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
- Adelaide, Campbelltown, Camperdown, and Woolloongabba, AustraliaSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small cell lung cancer whose tumour has a homozygous MTAP deletion and whose disease got worse after earlier treatment.
- Age
- 18 years or older (or the legal age of consent where the study takes place).
- Sex
- All sexes can join.
- Disease stage
- Advanced or metastatic non-small cell lung cancer that cannot be treated with treatment meant to remove all of the disease. At least 1 measurable lesion (RECIST v1.1). ECOG performance status 0-1.
- Earlier treatment
- The cancer must have grown on or after the most recent line of treatment. Earlier treatment with a PRMT5 or MAT2A inhibitor is not allowed. For the combination arms, earlier iza-bren or other antibody or ADC treatment aimed at EGFR and/or HER3, or with a topoisomerase 1 inhibitor payload, is not allowed (amivantamab is the exception).
- Biomarker or test result
- Homozygous MTAP deletion found in tumour tissue, confirmed centrally on archival or fresh samples. For the combination arms, EGFR status must be documented; EGFR mutant or wild type are both allowed.
Main reasons for not taking part
- Active brain metastases or carcinomatous meningitis
- Stomach or bowel disease that could change how the study drug is absorbed or stop you swallowing tablets
- Earlier treatment with a PRMT5 or MAT2A inhibitor
- Known severe allergy to the study treatment or its ingredients
- For the combination arms: earlier iza-bren or similar EGFR/HER3-targeting antibody or ADC treatment, except amivantamab
Read by machine on 9 November 2026.
Where in Australia
- Adelaide, South AustraliaHospital not named in the registryNo longer taking part
- GenesisCare - CampbelltownCampbelltown, AustraliaTaking people
- Chris O'Brien LifehouseCamperdown, AustraliaTaking people
- Princess Alexandra HospitalWoolloongabba, AustraliaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.