A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion

Phase 2

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: BMS-986504

• Registration Number: NCT06855771
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of BMS-986504 monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Study Start: 2025-05-30
• Primary Completion: 2028-12-29
• Study Completion: 2031-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm A: BMS-986504 Dose 1	BMS-986504	-
Arm B: BMS-986504 Dose 2	BMS-986504	-

Primary Outcome Measures

Name	Time	Method
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Up to 3 years after the last participant's last dose of study treatment	OR is defined as confirmed complete response (CR) or partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Number of participants who achieve disease control (DC) as assessed by RECIST v1.1	Up to 3 years after the last participant's last dose of study treatment	DC is defined as Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)
Number of participants who achieve clinical benefit (CB) as assessed by RECIST v1.1	Up to 3 years after the last participant's last dose of study treatment	CB is defined as BOR of confirmed CR, confirmed PR, or SD for at least 6 months after start of treatment
Duration of response (DOR) as assessed by RECIST v1.1	Up to 3 years after the last participant's last dose of study treatment	DOR is defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first)
Progression-free survival (PFS) as assessed by RECIST v1.1	Up to 3 years after the last participant's last dose of study treatment	PFS is defined as the time between randomization and the date of disease progression or death from any cause (whichever occurs first)
Time to objective response (TTOR) as assessed by RECIST v1.1	Up to 3 years after the last participant's last dose of study treatment	TTOR is defined as the time between randomization to the date of the first documentation of objective tumor response (CR or PR)
Number of participants with adverse events (AE)	Up to 28 days after the last dose of study treatment
Number of participants with Serious AEs (SAEs)	Up to 28 days after the last dose of study treatment
Number of participants with AEs leading to dose interruption, reduction, or discontinuation	Up to 28 days after the last dose of study treatment
Number of deaths	Up to 28 days after the last dose of study treatment
Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1	Up to 3 years after the last participant's last dose of study treatment	As assessed by Investigator
Overall Survival (OS)	Up to 3 years after the last participant's last dose of study treatment	OS is defined as the time between the randomization/the start of treatment to death due to any cause
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score	Up to 28 days after the last dose of study treatment
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core Function Global Health Status functional scale score	Up to 28 days after the last dose of study treatment
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score	Up to 28 days after the last dose of study treatment

Trial Locations

Locations (70)

Local Institution - 0088; 🇺🇸 Anchorage, Alaska, United States

Local Institution - 0099; 🇺🇸 Boise, Idaho, United States

Local Institution - 0090; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0100; 🇺🇸 Detroit, Michigan, United States

Local Institution - 0018; 🇺🇸 New York, New York, United States

Local Institution - 0079; 🇺🇸 Shirley, New York, United States

Local Institution - 0091; 🇺🇸 Canton, Ohio, United States

Local Institution - 0098; 🇺🇸 Portland, Oregon, United States

Local Institution - 0103; 🇺🇸 Portland, Oregon, United States

Local Institution - 0102; 🇺🇸 Houston, Texas, United States

Local Institution - 0078; 🇺🇸 Seattle, Washington, United States

Local Institution - 0084; 🇺🇸 Milwaukee, Wisconsin, United States

Local Institution - 0057; 🇦🇺 Campbelltown, New South Wales, Australia

Local Institution - 0059; 🇦🇺 Camperdown, New South Wales, Australia

Local Institution - 0058; 🇦🇺 Woolloongabba, Queensland, Australia

Local Institution - 0097; 🇦🇺 Adelaide, South Australia, Australia

Local Institution - 0039; 🇨🇳 Beijing, Beijing, China

Local Institution - 0055; 🇨🇳 Xiamen, Fujian, China

Local Institution - 0050; 🇨🇳 Nanning, Guangxi, China

Local Institution - 0043; 🇨🇳 Nanchang, Jiangxi, China

Local Institution - 0056; 🇨🇳 Changchun, Jilin, China

Local Institution - 0054; 🇨🇳 Jinan, Shandong, China

Local Institution - 0044; 🇨🇳 Linyi, Shandong, China

Local Institution - 0049; 🇨🇳 Hangzhou, Zhejiang, China

Local Institution - 0053; 🇨🇳 Linhai, Zhejiang, China

Local Institution - 0045; 🇫🇷 Marseille, Bouches-du-Rhône, France

Local Institution - 0015; 🇫🇷 La Tronche, Isère, France

Local Institution - 0012; 🇫🇷 Saint-Herblain, Loire-Atlantique, France

Local Institution - 0095; 🇫🇷 Vandoeuvre lès Nancy, Meurthe-et-Moselle, France

Local Institution - 0041; 🇫🇷 Bron, Rhône, France

Local Institution - 0013; 🇫🇷 Paris, France

Local Institution - 0027; 🇫🇷 Paris, France

Local Institution - 0096; 🇫🇷 Paris, Île-de-France, France

Local Institution - 0068; 🇩🇪 München, Bayern, Germany

Local Institution - 0070; 🇩🇪 Frankfurt, Hessen, Germany

Local Institution - 0066; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Local Institution - 0067; 🇩🇪 Köln, Germany

Local Institution - 0065; 🇩🇪 Wuerzburg, Germany

Local Institution - 0020; 🇮🇹 Napoli, Campania, Italy

Local Institution - 0026; 🇮🇹 Napoli, Campania, Italy

Local Institution - 0025; 🇮🇹 Monza, Lombardia, Italy

Local Institution - 0022; 🇮🇹 Milan, Milano, Italy

Local Institution - 0024; 🇮🇹 Bologna, Italy

Local Institution - 0019; 🇮🇹 Milan, Italy

Local Institution - 0023; 🇮🇹 Padova, Italy

Local Institution - 0092; 🇯🇵 Kashiwa, Chiba, Japan

Local Institution - 0094; 🇯🇵 Sendai, Miyagi, Japan

Local Institution - 0093; 🇯🇵 Hirakata, Osaka, Japan

Local Institution - 0060; 🇵🇱 Wieliszew, Mazowieckie, Poland

Local Institution - 0064; 🇵🇱 Prabuty, Pomorskie, Poland

Local Institution - 0040; 🇷🇴 Bucharest, București, Romania

Local Institution - 0029; 🇷🇴 Bucharest, București, Romania

Local Institution - 0036; 🇷🇴 Florești, Cluj, Romania

Local Institution - 0031; 🇷🇴 Craiova, Dolj, Romania

Local Institution - 0034; 🇷🇴 Cluj, Romania

Local Institution - 0030; 🇷🇴 Iași, Romania

Local Institution - 0032; 🇷🇴 Iași, Romania

Local Institution - 0074; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0073; 🇪🇸 Hospitalet, Barcelona [Barcelona], Spain

Local Institution - 0077; 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Local Institution - 0071; 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Local Institution - 0076; 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Local Institution - 0075; 🇪🇸 Málaga, Spain

Local Institution - 0089; 🇪🇸 Sevilla, Spain

Local Institution - 0072; 🇪🇸 València, Spain

Local Institution - 0002; 🇸🇪 Solna, Stockholms Län [se-01], Sweden

Local Institution - 0003; 🇸🇪 Gothenburg, Västra Götalands Län [se-14], Sweden

Local Institution - 0069; 🇬🇧 Birmingham, England, United Kingdom

Local Institution - 0008; 🇬🇧 London, London, City Of, United Kingdom

Local Institution - 0004; 🇬🇧 Newcastle upon Tyne, United Kingdom