A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
Purpose
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (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
Condition
- Metastatic Non-small Cell Lung Cancer With MTAP Deletion
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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/Exclusion criteria apply.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, 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.
Arm Groups
| Arm | Description | Assigned Intervention |
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Active Comparator Arm A: BMS-986504 + Pembrolizumab + Chemotherapy |
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Active Comparator Arm B: BMS-986504 + Pembrolizumab + Chemotherapy |
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Placebo Comparator Arm C: Placebo + Pembrolizumab + Chemotherapy |
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Placebo Comparator Arm D: Placebo + Pembrolizumab + Chemotherapy |
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Active Comparator Arm E: BMS-986504 + Pembrolizumab + Chemotherapy |
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Placebo Comparator Arm F: Placebo + Pembrolizumab + Chemotherapy |
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Recruiting Locations
Alaska Oncology and Hematology
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Contact:
Steven Liu, Site 0119
907-257-9851
Steven Liu, Site 0119
907-257-9851
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Contact:
Vinicius Ernani, Site 0388
480-342-4800
Vinicius Ernani, Site 0388
480-342-4800
University of Arizona Cancer Center
Tucson, Arizona 85724
Tucson, Arizona 85724
Contact:
Ricklie Julian, Site 0120
850-557-2723
Ricklie Julian, Site 0120
850-557-2723
Highlands Oncology Group
Springdale, Arkansas 72762
Springdale, Arkansas 72762
Contact:
Eric Schaefer, Site 0135
479-872-8130
Eric Schaefer, Site 0135
479-872-8130
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
Contact:
Robert Hsu, Site 0407
323-865-3000
Robert Hsu, Site 0407
323-865-3000
Helios Clinical Research - Fort Lauderdale
Fort Lauderdale, Florida 33316
Fort Lauderdale, Florida 33316
Contact:
Edgardo Santos, Site 0152
239-938-9315
Edgardo Santos, Site 0152
239-938-9315
Mayo Clinic in Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Contact:
Shenduo Li, Site 0389
904-953-0315
Shenduo Li, Site 0389
904-953-0315
St. Luke's Cancer Institute: Boise
Boise, Idaho 83712
Boise, Idaho 83712
Contact:
Sri Harsha Tella, Site 0124
Sri Harsha Tella, Site 0124
Baptist Health Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Contact:
Firas Badin, Site 0333
859-260-6100
Firas Badin, Site 0333
859-260-6100
University of Kentucky Chandler Medical Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Contact:
John Villano, Site 0125
859-323-6522
John Villano, Site 0125
859-323-6522
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Contact:
Pasi Janne, Site 0158
617-632-6036
Pasi Janne, Site 0158
617-632-6036
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
Konstantinos Leventakos, Site 0182
507-284-2511
Konstantinos Leventakos, Site 0182
507-284-2511
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
Omaha, Nebraska 68130
Contact:
Geetha Palaniappan, Site 0160
402-593-3141
Geetha Palaniappan, Site 0160
402-593-3141
WMCHealth Advanced Physician Services
Hawthorne, New York 10532
Hawthorne, New York 10532
Contact:
Marjorie Zauderer, Site 0179
914-493-8375
Marjorie Zauderer, Site 0179
914-493-8375
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Contact:
Timothy Burns, Site 0129
412-864-7859
Timothy Burns, Site 0129
412-864-7859
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Contact:
Rachel Sanborn, Site 0164
503-215-5696
Rachel Sanborn, Site 0164
503-215-5696
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon 97227
Portland, Oregon 97227
Contact:
Sandeep Mashru, Site 0348
503-249-3315
Sandeep Mashru, Site 0348
503-249-3315
Renovatio Clinical - El Paso
El Paso, Texas 79915
El Paso, Texas 79915
Contact:
Mary Crow, Site 0374
713-703-2398
Mary Crow, Site 0374
713-703-2398
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Contact:
Natalie Vokes, Site 0132
000-000-0000
Natalie Vokes, Site 0132
000-000-0000
Huntsman Cancer Institute
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Contact:
Matthew Gumbleton, Site 0354
801-587-4557
Matthew Gumbleton, Site 0354
801-587-4557
Virginia Commonwealth University
Richmond, Virginia 23219
Richmond, Virginia 23219
Contact:
Renato Martins, Site 0186
804-828-7999
Renato Martins, Site 0186
804-828-7999
Fred Hutchinson Cancer Center
Seattle, Washington 98109
Seattle, Washington 98109
Contact:
Lei Deng, Site 0145
206-606-4801
Lei Deng, Site 0145
206-606-4801
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com