Fact CheckerSign in

NCT06855771RecruitingPhase 2

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)

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

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
182 (estimated)
First submitted
27 Feb 2025
Start date
9 Sept 2025
Primary completion date
29 Dec 2028
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT06855771
EU CT number
2024-519814-29-00
EudraCT number
2024-519814-29

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 182
  • From 9 Sept 2025 to the primary completion date, 29 Dec 2028
  • 66 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with a PRMT5 or MAT2A inhibitor.

Other illness

  • 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.

Lab values

  • 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.

Other

  • Active brain metastases or carcinomatous meningitis.
  • Other protocol-defined inclusion/exclusion criteria apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (66)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
AdelaideAustraliaCompleted
GenesisCare - Campbelltown
Coordinator of this site? Confirm its status
CampbelltownAustraliaRecruiting
Chris O'Brien Lifehouse
Coordinator of this site? Confirm its status
CamperdownAustraliaRecruiting
Princess Alexandra Hospital
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaRecruiting
Beijing chest hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Shandong Cancer Hospital
Coordinator of this site? Confirm its status
JinanChinaRecruiting
Taizhou Hospital of Zhejiang Province
Coordinator of this site? Confirm its status
LinhaiChinaRecruiting
LinYi Cancer Hospital
Coordinator of this site? Confirm its status
LinyiChinaRecruiting
The First Affiliated Hospital of NanChang University
Coordinator of this site? Confirm its status
NanchangChinaRecruiting
Guangxi Medical University Affiliated Tumor Hospital
Coordinator of this site? Confirm its status
NanningChinaRecruiting
The First Affiliated hospital of Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaRecruiting
University Hospital Cologne AöR
Coordinator of this site? Confirm its status
CologneGermanyRecruiting
Goethe University Frankfurt
Coordinator of this site? Confirm its status
Frankfurt Am MainGermanyRecruiting
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Coordinator of this site? Confirm its status
Halle (saale)GermanyRecruiting
Klinikum der Universitaet Muenchen AöR
Coordinator of this site? Confirm its status
MunichGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
Coordinator of this site? Confirm its status
WuerzburgGermanyRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Institut Catala D'oncologia
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
BronFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
Coordinator of this site? Confirm its status
Grenoble Cedex 9FranceRecruiting
Institut Curie
Coordinator of this site? Confirm its status
ParisFranceRecruiting
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
Saint-HerblainFranceRecruiting
CHRU De Nancy
Coordinator of this site? Confirm its status
Vandoeuvre Les NancyFranceRecruiting
Queen Elizabeth Hospital Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited KingdomRecruiting
Sarah Cannon Research Institute UK
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Freeman Hospital
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Istituto Oncologico Veneto
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
Kansai Medical University Hospital
Coordinator of this site? Confirm its status
HirakataJapanRecruiting
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
KashiwaJapanRecruiting
Sendai Kousei Hospital
Coordinator of this site? Confirm its status
SendaiJapanRecruiting
Szpital Specjalistyczny w Prabutach Sp. z o.o.
Coordinator of this site? Confirm its status
PrabutyPolandRecruiting
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Coordinator of this site? Confirm its status
WieliszewPolandRecruiting
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Centrul De Diagnostic Si Tratament Provita S.A.
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaRecruiting
Centrul De Oncologie SF Nectarie S.R.L.
Coordinator of this site? Confirm its status
CraiovaRomaniaRecruiting
Radiotherapy Center Cluj S.R.L.
Coordinator of this site? Confirm its status
FlorestiRomaniaRecruiting
Centrul De Oncologie-Euroclinic S.R.L.
Coordinator of this site? Confirm its status
IasiRomaniaRecruiting
Institutul Regional de Oncologie Iasi
Coordinator of this site? Confirm its status
IașiRomaniaRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Coordinator of this site? Confirm its status
GoteborgSwedenRecruiting
Karolinska University Hospital
Coordinator of this site? Confirm its status
SolnaSwedenRecruiting
-
Coordinator of this site? Confirm its status
AnchorageUnited StatesCompleted
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Gabrail Cancer Center
Coordinator of this site? Confirm its status
CantonUnited StatesRecruiting
Karmanos Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Providence Portland Medical Center
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Oregon Health and Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Fred Hutchison Cancer Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.