NCT06855771RecruitingPhase 2
A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating 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
Bristol-Myers Squibb129 sites in 9 countries130 target enrollmentStarted: September 9, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 129
- Primary Endpoint
- Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Documented radiographic disease progression on or after the most recent line of treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •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.
Arms & Interventions
Arm B: BMS-986504 Dose 2
Experimental
Intervention: BMS-986504 (Drug)
Arm A: BMS-986504 Dose 1
Experimental
Intervention: BMS-986504 (Drug)
Outcomes
Primary Outcomes
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: 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 Outcomes
- 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)
- 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)
- Duration of response (DOR) as assessed by RECIST v1.1(Up to 3 years after the last participant's last dose of study treatment)
- Progression-free survival (PFS) as assessed by RECIST v1.1(Up to 3 years after the last participant's last dose of study treatment)
- 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)
- 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)
- Overall Survival (OS)(Up to 3 years after the last participant's last dose of study treatment)
- 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)
- 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)
- 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)
- Duration of response (DOR) as assessed by RECIST v1.1(Up to 3 years after the last participant's last dose of study treatment)
- 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)
- 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)
- Overall Survival (OS)(Up to 3 years after the last participant's last dose of study treatment)
- 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)
- Progression-free survival (PFS) as assessed by RECIST v1.1(Up to 3 years after the last participant's last dose of study treatment)
- 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 deaths(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)
Investigators
Study Sites (129)
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