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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Specified dose on specified days
Specified dose on specified days
Local Institution - 0088
Anchorage, Alaska, United States
COMPLETEDDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
OR is defined as confirmed complete response (CR) or partial response (PR)
Time frame: Up to 3 years after the last participant's last dose of study treatment
Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Arm C and Arm D
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with adverse events (AE)
Arm C and Arm D
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with Serious AEs (SAEs)
Arm C and Arm D
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with treatment related AEs
Arm C and Arm D
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with treatment related SAEs
Arm C and Arm D
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with AEs leading to study treatment discontinuation
Arm C and Arm D
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with AEs leading to death
Arm C and Arm D
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with laboratory abnormalities
Arm C and Arm D
Time frame: 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
DC is defined as Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)
Time frame: 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
CB is defined as BOR of confirmed CR, confirmed PR, or SD for at least 6 months after start of treatment
Time frame: Up to 3 years after the last participant's last dose of study treatment
Duration of response (DOR) as assessed by RECIST v1.1
DOR is defined as the time between the date of the first documentation of objective tumor response (confirmed CR or PR) and the date of disease progression or to death from any cause (whichever occurs first)
Time frame: Up to 3 years after the last participant's last dose of study treatment
Progression-free survival (PFS) as assessed by RECIST v1.1
PFS is defined as the time between randomization and the date of disease progression or death from any cause (whichever occurs first)
Time frame: 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
TTOR is defined as the time between randomization to the date of the first documentation of objective tumor response (confirmed CR or PR)
Time frame: Up to 3 years after the last participant's last dose of study treatment
Number of participants with adverse events (AE)
Time frame: Up to 28 days after the last dose of study treatment
Number of participants with Serious AEs (SAEs)
Time frame: Up to 28 days after the last dose of study treatment
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGGabrail Cancer Center
Canton, Ohio, United States
RECRUITINGProvidence Portland Medical Center
Portland, Oregon, United States
RECRUITINGOregon Health and Science University
Portland, Oregon, United States
RECRUITINGFred Hutchison Cancer Center
Seattle, Washington, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING...and 57 more locations
Number of participants with AEs leading to dose interruption, reduction, or discontinuation
Time frame: Up to 28 days after the last dose of study treatment
Number of deaths
Time frame: 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
Time frame: Up to 3 years after the last participant's last dose of study treatment
Overall Survival (OS)
OS is defined as the time between the randomization/the start of treatment to death due to any cause
Time frame: 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
Time frame: 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 score
Time frame: 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
Time frame: Up to 28 days after the last dose of study treatment