NCT06855771 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)
| NCT ID | NCT06855771 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2028-12-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2025-09-09 with a primary completion date of 2028-12-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria * 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). Exclusion Criteria * 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06855771 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Non-Small-Cell Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06855771 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06855771 currently recruiting?
Yes, NCT06855771 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06855771 trial being conducted?
This trial is being conducted at Anchorage, United States, Boise, United States, Boston, United States, Detroit, United States and 11 additional locations.
Who is sponsoring the NCT06855771 clinical trial?
NCT06855771 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 130 participants.