A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT06875310
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adagrasib — DRUG
    Specified dose on specified days
  • Pembrolizumab — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days

Study Details

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

Key Dates

Start date
Apr 24, 2025
Status verified
Jun 2026
Primary completion
Sep 7, 2029
Completion
Apr 30, 2032

Study Design

Enrollment
630 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adagrasib
  • Placebo Comparator: Placebo

Primary Outcome Measure

Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to 7 years ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (54)

FacilityCityStateZIPSite coordinators
Local Institution - 0347BirminghamAlabama35294
Site 0347
Local Institution - 0686SpringdaleArkansas72762
Site 0686
Local Institution - 0581FullertonCalifornia92835
Site 0581
Local Institution - 0682Loma LindaCalifornia92354
Site 0682
Helios Clinical ResearchLong BeachCalifornia90805
Omkar Marathe, Site 0202
562-693-4477
Local Institution - 0442DenverColorado80206
Site 0442
Local Institution - 0701NewarkDelaware19713
Site 0701
Local Institution - 0694ClearwaterFlorida33756
Site 0694
Cancer Specialists of North FloridaJacksonvilleFlorida32256
Laura Lourdes, Site 0052
904-538-4488
Local Institution - 0696MiamiFlorida33176
Site 0696
Local Institution - 0680OcalaFlorida34474
Site 0680
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763
Santosh Nair, Site 0679
407-353-1915
Cancer Care Centers of Brevard, Inc.Palm BayFlorida32901
venkat pavan kancharla, Site 0621
111-111-1111
Florida Clinical Trials Group.PlantationFlorida33322
Harshad Amin, Site 0365
561-447-0614
Local Institution - 0695St. PetersburgFlorida33705
Site 0695
Florida Clinical Trials Group.TamaracFlorida33321
Chintan Gandhi, Site 0377
561-447-0614
Local Institution - 0647TampaFlorida33612
Site 0647
Local Institution - 0699TampaFlorida33612
Site 0699
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalMariettaGeorgia30060
Walid Shaib, Site 0031
770-281-5124
Illinois Cancer SpecialistsArlington HeightsIllinois60005
David Hakimian, Site 0665
847-827-9060
Local Institution - 0676ChicagoIllinois60612
Site 0676
Local Institution - 0683SpringfieldIllinois62703
Site 0683
Local Institution - 0454DyerIndiana46311
Site 0454
Local Institution - 0684Fort WayneIndiana46845
Site 0684
Local Institution - 0423MunsterIndiana46321-
Mercy Medical CenterCedar RapidsIowa52403
Ann Stroh, Site 0691
Local Institution - 0366EdgewoodKentucky41017
Site 0366
Local Institution - 0566LouisvilleKentucky40202
Site 0566
Local Institution - 0693OwensboroKentucky42303
Site 0693
Local Institution - 0698PaducahKentucky42003
Site 0698
Local Institution - 0644ShreveportLouisiana71103
Site 0644
Local Institution - 0702AnnapolisMaryland21401
Site 0702
Maryland Oncology Hematology - ColumbiaColumbiaMaryland21044
Mohit Narang, Site 0385
817-837-8660
Local Institution - 0019BostonMassachusetts02215
Site 0019
Local Institution - 0293DetroitMichigan48201
Site 0293
Local Institution - 0685FentonMissouri63026
Site 0685
Local Institution - 0678CooperstownNew York13326
Site 0678
Local Institution - 0689RochesterNew York14642
Site 0689
Ellis HospitalSchenectadyNew York12308
Tallat Mahmood, Site 0634
517-331-4405
Local Institution - 0618White PlainsNew York10601
Site 0618
Local Institution - 0624AshevilleNorth Carolina28806
Site 0624
Local Institution - 0672SalisburyNorth Carolina28144
Site 0672
Local Institution - 0688EastonPennsylvania18045
Site 0688
Local Institution - 0376HersheyPennsylvania17033
Site 0376
WellSpan Oncology ResearchYorkPennsylvania17403
Ikechukwu Akunyili, Site 0657
717-339-2560
Local Institution - 0658GreenvilleSouth Carolina29607
Site 0658
Local Institution - 0681GreenvilleSouth Carolina29605-
Local Institution - 0697NashvilleTennessee37212
Site 0697
SCRI Oncology PartnersNashvilleTennessee37203
David Spigel, Site 0020
615-320-5090
Local Institution - 0034DallasTexas75246
Site 0034
Local Institution - 0692GalvestonTexas77555
Site 0692
Local Institution - 0652LaredoTexas78041
Site 0652
Texas Oncology - San AntonioSan AntonioTexas78217
Krishna Alluri, Site 0622
210-656-7177
Local Institution - 0700TylerTexas75702
Site 0700

Find similar trials in Birmingham, AL

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Local Institution - 0347· Birmingham, ALLocal Institution - 0686· Springdale, ARLocal Institution - 0581· Fullerton, CALocal Institution - 0682· Loma Linda, CAHelios Clinical Research· Long Beach, CALocal Institution - 0442· Denver, CO

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