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Looking for participantsPhase2

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)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT06855771

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BMS-986504 (drug), Izalontamab Brengitecan (drug)
How long the study runs
Study runs about 75 months (dates as stated)
About the drug or intervention
BMS-986504 — drug: Specified dose on specified days · Izalontamab Brengitecan — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
182
Started
2025-09-09
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoma, non-small-cell lung
  • • Phase2 - 182 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with carcinoma, non-small-cell lung

Where?

  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • London - Sarah Cannon Research Institute UK
  • • Newcastle upon Tyne - Freeman Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Carcinoma, Non-Small-Cell Lung

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

EGFRmutant or wild type

Treatment history

Treatments you must have had:

  • ✓ documented evidence of EGFR status
  • ✓ a PRMT5
  • ✓ iza-bren

What the study is looking for

  • ✓Inclusion Criteria
  • ✓confirmed by a biopsy diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to...
  • ✓Advanced or that has spread NSCLC not amenable to curative therapies after progression on prior therapies at the time of...
  • ✓At least 1 measurable lesion as per (standard scan measurements).
  • ✓Documented radiographic disease progression on or after the most recent line of treatment.
See the full 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). * For combination arms 1. Participants must have documented evidence of EGFR status. 2. Participants with EGFR mutant or wild type NSCLC are allowed. 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. * 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 Is This Study? (3 UK sites)

Queen Elizabeth Hospital Birmingham

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Gary Middleton, Site 0069+44 121 3718783

Sarah Cannon Research Institute UK

London w1g 6ad, United Kingdom

Recruiting
Site contact (verified)
Elisa Fontana, Site 0008+44 (0) 203 219 5234

Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)
Alastair Greystoke, Site 0004+44 (0)191 213 8450

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09