Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
DRUGBMS-986504
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 v1.1. * 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
Countries
Australia, China, France, Germany, Italy, Japan, Poland, Romania, Spain, Sweden, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed