Metastatic Non-small Cell Lung Cancer With MTAP Deletion
Conditions
Keywords
PRMT5, Lung cancer, NSCLC, MTAP, CDKN2A, MRTX1719, First-line, Navlimetostat
Brief summary
The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion
Interventions
DRUGBMS-986504
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
DRUGCisplatin
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
DRUGPemetrexed
Specified dose on specified days
DRUGPaclitaxel
Specified dose on specified days
DRUGNab-paclitaxel
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Phase 2 portion of this study will be blinded to sites, participants, investigators, and certain site-facing members of the Sponsor. The Phase 3 portion of this study will be blinded to participants, investigators, and the Sponsor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease. * Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Participants must have at least 1 measurable lesion as per RECIST v1.1.
Exclusion criteria
* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy. * Participants must not have symptomatic brain metastases or spinal cord compression. * Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated. * Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) by RECIST v1.1 | Up to 2 years | Phase 2 |
| PFS by RECIST v1.1 per BICR | Up to 5 years | Phase 3 |
| Overall Survival (OS) | Up to 5 years | Phase 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response (OR) (confirmed complete response (CR) or partial response (PR)) | Up to 2 years | Phase 2 |
| Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)) | Up to 2 years | Phase 2 |
| Duration of response (DOR) (CR or PR) | Up to 2 years | Phase 2 |
| Time to objective response (TTOR) (CR or PR) | Up to 2 years | Phase 2 |
| Number of participants with treatment-related and all-cause adverse events (AEs) | Up to 90 days from the last dose | Phase 2 |
| Number of participants with serious adverse events (SAEs) including fatal AEs | Up to 90 days from the last dose | Phase 2 |
| Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation | Up to 90 days from the last dose | Phase 2 |
| Number of participants with laboratory abnormalities | Up to 90 days from the last dose | Phase 2 |
| OR (confirmed CR or PR) | Up to 5 years | Phase 3 |
| Disease control (BOR of confirmed CR, confirmed PR, or SD) | Up to 5 years | Phase 3 |
| DOR (CR or PR) | Up to 5 years | Phase 3 |
| PFS by RECIST v1.1 per Investigator | Up to 5 years | Phase 3 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Romania, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), 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