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Purpose

This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA). - Locally advanced or metastatic disease. - Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion. - No prior systemic anti-cancer therapy given for advanced or metastatic disease. - Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection). - Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter. - Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.

Exclusion Criteria

  • Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years. - Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence. - Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities. - Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry. - Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Adagrasib
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503; KRAZATI®
  • Drug: Pembrolizumab
    Specified dose on specified days
    Other names:
    • KEYTRUDA®
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Pemetrexed
    Specified dose on specified days
  • Drug: Cisplatin
    Specified dose on specified days
Placebo Comparator
Placebo
  • Drug: Pembrolizumab
    Specified dose on specified days
    Other names:
    • KEYTRUDA®
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Pemetrexed
    Specified dose on specified days
  • Drug: Placebo
    Specified dose on specified days
  • Drug: Cisplatin
    Specified dose on specified days

Recruiting Locations

Helios Clinical Research
Long Beach, California 90805
Contact:
Omkar Marathe, Site 0202
562-693-4477

Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713
Contact:
Jamal Misleh, Site 0701
302-366-1200

Cancer Specialists of North Florida
Jacksonville, Florida 32256
Contact:
Laura Lourdes, Site 0052
904-538-4488

Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
Contact:
Santosh Nair, Site 0679
407-353-1915

Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida 32901
Contact:
venkat pavan kancharla, Site 0621
111-111-1111

Florida Clinical Trials Group.
Plantation, Florida 33322
Contact:
Harshad Amin, Site 0365
561-447-0614

Florida Clinical Trials Group.
Tamarac, Florida 33321
Contact:
Chintan Gandhi, Site 0377
561-447-0614

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia 30060
Contact:
Walid Shaib, Site 0031
770-281-5124

Illinois Cancer Specialists
Arlington Heights, Illinois 60005
Contact:
David Hakimian, Site 0665
847-827-9060

Mercy Medical Center
Cedar Rapids, Iowa 52403
Contact:
Ann Stroh, Site 0691

Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky 41017
Contact:
Colleen Darnell, Site 0366
859-301-4000

Owensboro Medical Health System
Owensboro, Kentucky 42303
Contact:
Jewraj Maheshwari, Site 0693

Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana 71103
Contact:
Kavitha Beedupalli, Site 0644
318-813-3061

Maryland Oncology Hematology - Columbia
Columbia, Maryland 21044
Contact:
Mohit Narang, Site 0385
817-837-8660

Ellis Hospital
Schenectady, New York 12308
Contact:
Tallat Mahmood, Site 0634
517-331-4405

WellSpan Oncology Research
York, Pennsylvania 17403
Contact:
Ikechukwu Akunyili, Site 0657
717-339-2560

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
David Spigel, Site 0020
615-320-5090

Texas Oncology Sammons Cancer Center
Dallas, Texas 75246
Contact:
Kartik Konduri, Site 0034
214-370-1000

Texas Oncology - San Antonio
San Antonio, Texas 78217
Contact:
Krishna Alluri, Site 0622
210-656-7177

Texas Oncology - Northeast Texas
Tyler, Texas 75702
Contact:
Shail Dalal, Site 0700
903-727-2200

More Details

Status
Recruiting
Sponsor
Mirati Therapeutics Inc.

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.