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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)

NCT06855771

RecruitingPhase 2

Sponsor: Bristol-Myers Squibb

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: BMS-986504

Countries: United States, Australia, China, France, Germany, Italy, Japan, Poland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (70)

Anchorage, Alaska, United States
Boise, Idaho, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Shirley, New York, United States
Canton, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Campbelltown, New South Wales, Australia
Camperdown, New South Wales, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Beijing, Beijing Municipality, China
Xiamen, Fujian, China
Nanning, Guangxi, China
Nanchang, Jiangxi, China
Jinan, Shandong, China
Linyi, Shandong, China
Hangzhou, Zhejiang, China
Linhai, Zhejiang, China
Marseille, Bouches-du-Rhône, France
La Tronche, Isère, France
Saint-Herblain, Loire-Atlantique, France
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Bron, Rhône, France
Paris, France
+ 40 more on CT.gov