Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT04613596
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Non-Small Cell Lung Cancer
  • Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Adagrasib — DRUG
    Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)
  • Adagrasib — DRUG
    Adagrasib 600 mg BID monotherapy (Cohort 1b)
  • Adagrasib — DRUG
    adagrasib 400 mg BID in combination with pembrolizumab
  • Adagrasib — DRUG
    Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg IV Q3W

Study Details

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

Key Dates

Start date
Dec 2, 2020
Status verified
Jun 2026
Primary completion
Jun 9, 2032
Completion
Jun 9, 2032

Study Design

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

Arms

  • Experimental: Phase 2 Cohort 1a: PD-L1 TPS <1%
    Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab
  • Experimental: Phase 2 Cohort 1b: PD-L1 TPS <1%
    Cohort 1b: Adagrasib BID monotherapy
  • Experimental: Phase 2 Cohort 2: PD-L1 TPS ≥1%
    Cohort 2: Adagrasib BID in combination with pembrolizumab
  • Experimental: Phase 3 Cohort 3 Investigational Arm
    Adagrasib BID in combination with pembrolizumab
  • Active Comparator: Phase 3 Cohort 4 Comparator Arm
    Pembrolizumab

Primary Outcome Measure

Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC. [ Time Frame: 22 months ]

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 (220)

FacilityCityStateZIPSite coordinators
Local Institution - 007-556-AGoodyearArizona85395
Site 007-556-A
USOR - Arizona Oncology - Prescott ValleyPrescott ValleyArizona86301
Allan Espinosa Morazan, Site 007-556
928-775-9430
Local Institution - 007-568-ASaffordArizona85546
Site 007-568-A
Local Institution - 007-568-BSaffordArizona85546
Site 007-568-B
Local Institution - 007-568-CSaffordArizona85546
Site 007-568-C
Local Institution - 007-568-DSaffordArizona85546
Site 007-568-D
Local Institution - 007-568-ESaffordArizona85546
Site 007-568-E
Arizona Clinical Research CenterTucsonArizona85715
Manuel Modiano, Site 007-568
520-290-2510
Highlands Oncology Group - SpringdaleSpringdaleArkansas72762
Eric Schaefer, Site 007-978
479-872-8130
Providence - Saint Joseph Home Health - AnaheimAnaheimCalifornia92805
Giribala Patel, Site 007-899
714-446-5900
The Oncology Institute of Hope and Innovation - Corporate OfficeCerritosCalifornia90703
Omkar Marathe, Site 007-898
562-693-4477
Local Institution - 007-777Fountain ValleyCalifornia92708
Site 007-777
Local Institution - 007-778Laguna HillsCalifornia92653
Site 007-778
Local Institution - 007-898-BLong BeachCalifornia90805
Site 007-898-B
MemorialCare - Long Beach Medical CenterLong BeachCalifornia90806
Nilesh Vora, Site 007-936
562-997-4070
TRIO - Cancer & Blood Specialty Clinic - Los AlamitosLos AlamitosCalifornia90720
Nihal Abdulla, Site 007-779
562-706-6648
Local Institution - 007-579Los AngelesCalifornia90048-
Local Institution - Unk045Rancho MirageCalifornia92270-
San Francisco Veterans Affairs Medical CenterSan FranciscoCalifornia94121
Sunny Wang, Site 007-581
415-221-4810x23380
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Collin Blakely, Site 007-540
415-502-6959
Local Institution - 007-898-CSanta AnaCalifornia92705
Site 007-898-C
Providence Medical Group - Santa RosaSanta RosaCalifornia95403
Manasa Vulchi, Site 007-858
707-521-3830
Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B)StocktonCalifornia95219
Sunny K. Philip, Jr., Site 007-582
209-466-2626
Local Institution - 007-898-AWhittierCalifornia90602
Site 007-898-A
Local Institution - 007-872-HAuroraColorado80012
Site 007-872-H
Local Institution - 007-872-DBoulderColorado80303
Site 007-872-D
Local Institution - 007-872-LCentennialColorado80112
Site 007-872-L
Local Institution - 007-872-CColorado SpringsColorado80907
Site 007-872-C
Local Institution - 007-872-KColorado SpringsColorado80920
Site 007-872-K
Local Institution - 007-872-EDenverColorado80218
Site 007-872-E
Local Institution - 007-872-IDenverColorado80220
Site 007-872-I
Local Institution - 007-872-ALakewoodColorado80228
Site 007-872-A
Local Institution - 007-872-JLittletonColorado80218
Site 007-872-J
USOR - Rocky Mountain Cancer Centers - Lone TreeLone TreeColorado80124
Robert Jotte, Site 007-872
303-430-2700
Local Institution - 007-872-GLongmontColorado80504
Site 007-872-G
Local Institution - 007-872-BPuebloColorado81003
Site 007-872-B
Local Institution - 007-872-FThorntonColorado80260
Site 007-872-F
Eastern Connecticut Hematology and Oncology AssociatesNorwichConnecticut06360
Dennis Slater, Site 007-949
860-886-8362
Local Institution - 007-5476Washington D.C.District of Columbia20010
Site 007-5476
GenesisCare USAAventuraFlorida33180
Edgardo Santos, Site 007-552
239-938-9315
Bay Pines Veterans Affairs Healthcare SystemBay PinesFlorida33744
Ryan Burri, Site 007-593
727-398-6661
Local Institution - 007-922-ABonita SpringsFlorida34135
Site 007-922-A
Local Institution - 007-922-DBradentonFlorida34211
Site 007-922-D
Local Institution - 007-922-ECape CoralFlorida33909
Site 007-922-E
Local Institution - 007-896-ACelebrationFlorida34747
Site 007-896-A
Local Institution - 007-926-BDaytona BeachFlorida32117
Site 007-926-B
Local Institution - 007-562-BFleming IslandFlorida32003
Site 007-562-B
Local Institution - 007-922-BFort MyersFlorida33905
Site 007-922-B
Local Institution - 007-922-CFort MyersFlorida33908
Site 007-922-C
SCRI - Florida Cancer Specialists - South Region Research OfficeFort MyersFlorida33901
Fadi Kayali, Site 007-922
239-274-9930
21st Century Oncology of Jacksonville - North Lee StreetJacksonvilleFlorida32204
Troy Guthrie, Site 007-853
904-805-7061
Cancer Specialists of North Florida - SouthpointJacksonvilleFlorida32256
Gaurav Trikha, Site 007-562
203-530-1728
Local Institution - 007-562-CJacksonvilleFlorida32258
Site 007-562-C
Local Institution - 007-562-DJacksonvilleFlorida32204
Site 007-562-D
Local Institution - 007-562-EJacksonvilleFlorida32207
Site 007-562-E
Local Institution - 007-562-GJacksonvilleFlorida32218
Site 007-562-G
Local Institution - 007-829JacksonvilleFlorida32224-
Local Institution - 007-562-FJacksonville BeachFlorida32250
Site 007-562-F
Miami Veterans Affairs Healthcare SystemMiamiFlorida33125-1624
Gregory Holt, Site 007-594
305-575-7000
Local Institution - 007-922-FNaplesFlorida34102
Site 007-922-F
Local Institution - 007-922-GNaplesFlorida34102
Site 007-922-G
AdventHealth OrlandoOrlandoFlorida32803
Mark Socinski, Site 007-896
412-647-2811
USOR - Woodlands Medical SpecialistsPensacolaFlorida32503
Michael Poiesz, Site 007-877
850-696-4000
Local Institution - 007-922-HPort CharlotteFlorida33980
Site 007-922-H
Local Institution - 007-562-ASaint AugustineFlorida32086
Site 007-562-A
Local Institution - 007-922-ISarasotaFlorida34232
Site 007-922-I
Local Institution - 007-922-JSarasotaFlorida34236
Site 007-922-J
Local Institution - 007-926-DStuartFlorida34994
Site 007-926-D
Local Institution - 007-924-ATallahasseeFlorida32308
Site 007-924-A
SCRI - Florida Cancer Specialists - Tallahassee Cancer CenterTallahasseeFlorida32308
Augusto Villegas, Site 007-924
904-613-4275
James A. Haley Veterans HospitalTampaFlorida33612
John Accomando, Site 007-937
813-391-7763
Local Institution - Unk065TampaFlorida33612-
Local Institution - 007-922-KVeniceFlorida34292
Site 007-922-K
Local Institution - 007-922-LVeniceFlorida34285
Site 007-922-L
Local Institution - 007-926-CVero BeachFlorida32960
Site 007-926-C
Local Institution - 007-926-AWellingtonFlorida33414
Site 007-926-A
SCRI - Florida Cancer Specialists - West Palm BeachWest Palm BeachFlorida33401
Barry Berman, Site 007-926
407-933-2775
Local Institution - Unk072WestonFlorida33331-
University Cancer & Blood Center (UCBC) - AthensAthensGeorgia30607
Gustavo Westin, Site 007-941
706-353-2990
Local Institution - Unk052AtlantaGeorgia30318-
Local Institution - 007-786-CCarrolltonGeorgia30117
Site 007-786-C
Local Institution - 007-786-ACartersvilleGeorgia30121
Site 007-786-A
Local Institution - 007-786-DDouglasvilleGeorgia30134
Site 007-786-D
Local Institution - 007-786-BHiramGeorgia30141
Site 007-786-B
Central Georgia Cancer Care - MaconMaconGeorgia31201
Bradley Sumrall, Site 007-5478
4787417145
Northwest Georgia Oncology Centers Wellstar - MariettaMariettaGeorgia30060
Steven McCune, Site 007-786
770-281-5162
Local Institution - 007-897HonoluluHawaii96813-
Local Institution - Unk005HonoluluHawaii96813-
Local Institution - 007-883-AArlington HeightsIllinois60005
Site 007-883-A
Local Institution - 007-955ChicagoIllinois60612-
University of ChicagoChicagoIllinois60637
Marina Garassino, Site 007-972
718-675-2060
Loyola University Medical CenterMaywoodIllinois60153
Nan Sethakorn, Site 007-064
USOR - Illinois Cancer Specialists - NilesNilesIllinois60714
David Hakimian, Site 007-883
847-827-9060
Advocate Medical Group OncologyPark RidgeIllinois60068
Jason Macklis, Site 007-567
000-000-0000
Local Institution - Unk061PeoriaIllinois61603-3200-
Goshen Center for Cancer CareGoshenIndiana46526
Ebenezer Kio, Site 007-943
574-364-2848
Local Institution - 007-942-BChanuteKansas66720
Site 007-942-B
Local Institution - 007-942-DEl DoradoKansas67042
Site 007-942-D
Local Institution - 007-942-EIndependenceKansas67301
Site 007-942-E
Local Institution - 007-942-FKingmanKansas67068
Site 007-942-F
Local Institution - 007-942-GLiberalKansas67901
Site 007-942-G
Local Institution - 007-942-HMcPhersonKansas67460
Site 007-942-H
MidAmerica Cancer Care - ResearchMerriamKansas66204
Jaswinder Singh, Site 007-5484
8162764700
Local Institution - 007-942-INewtonKansas67114
Site 007-942-I
Local Institution - 007-942-JParsonsKansas67357
Site 007-942-J
Local Institution - 007-942-KPrattKansas67124
Site 007-942-K
Local Institution - 007-942-LSalinaKansas67401
Site 007-942-L
Local Institution - 007-942-MWellingtonKansas67152
Site 007-942-M
Local Institution - Unk032WestwoodKansas66205-
Cancer Center of Kansas - Wichita - Heritage PlazaWichitaKansas67214
Shaker Dakhil, Site 007-942
316-262-4467
Local Institution - 007-942-AWichitaKansas67208
Site 007-942-A
Local Institution - 007-942-NWinfieldKansas67156
Site 007-942-N
Lexington Medical Cancer Center Hematology/OncologyLexingtonKentucky40503
Firas Badin, Site 007-965
859-260-6100
Local Institution - 007-388-ALouisvilleKentucky40245
Site 007-388-A
University of LouisvilleLouisvilleKentucky40202
Goetz Kloecker, Site 007-388
Local Institution - Unk011Baton RougeLouisiana70809-
Local Institution - 007-994-ACovingtonLouisiana70433
Site 007-994-A
Pontchartrain Cancer Center - Covington OfficeCovingtonLouisiana70433
David Oubre, Site 007-994
985-875-1202
The Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231
Kristen Marrone, Site 007-944
410-550-1711
Dana-Farber Cancer InstituteBostonMassachusetts02215
Pasi Janne, Site 007-808
617-632-6036
Dana-Farber Cancer Institute at St. Elizabeths Medical CenterBrightonMassachusetts02135
Alys Malcolm, Site 007-5483
Brigham and Womens/Mass General Health Care Center at FoxboroughFoxboroughMassachusetts02035
Naeem Tahir, Site 007-5480
7344536970
Dana-Farber Cancer Institute - Merrimack ValleyMethuenMassachusetts01844
Pedro Sanz-Altamira, Site 007-5482
9786202020
Dana-Farber Brigham and Womens Cancer Center at Milford RegionalMilfordMassachusetts01757
Alexandra Bailey, Site 007-5479
7813379091
Dana-Farber Brigham Cancer Center at South Shore HealthSouth WeymouthMassachusetts02190
Randi Carhart, Site 007-5481
7816244800
USOR - Minnesota Oncology - BurnsvilleBurnsvilleMinnesota55337
Sandeep Jain, Site 007-589
Local Institution - 007-589AEdinaMinnesota55435
Site 007-589A
Local Institution - 007-822MinneapolisMinnesota55455-
Local Institution - Unk006MinneapolisMinnesota55404-
Local Institution - 007-830RochesterMinnesota55905-
Jackson Oncology Associates - The Hederman Cancer CenterJacksonMississippi39202
Natale Sheehan, Site 007-588
601-355-2485
Local Institution - 007-590DGrand IslandNebraska68803
Site 007-590D
Local Institution - 007-590AOmahaNebraska68114-4108
Site 007-590A
Local Institution - 007-590BOmahaNebraska68124
Site 007-590B
Nebraska Cancer Specialists - Midwest Cancer Center - LegacyOmahaNebraska68130
Mary Wells, Site 007-590
531-329-3667
Local Institution - 007-590CPapillionNebraska68046
Site 007-590C
Local Institution - 007-938ALas VegasNevada89148
Site 007-938A
Local Institution - 007-938BLas VegasNevada89148
Site 007-938B
OptumCare NevadaLas VegasNevada89106
Russell Gollard, Site 007-938
000-000-0000
Local Institution - 007-993BellevilleNew Jersey07109-
Astera Cancer Care - East BrunswickEast BrunswickNew Jersey08816
Bruno Fang, Site 007-975
301-435-5332
John Theurer Cancer CenterHackensackNew Jersey07601
Martin Gutierrez, Site 007-854
954-267-7700
Local Institution - 007-975-ASomersetNew Jersey08873-5002
Site 007-975-A
Local Institution - 007-975-BSomersetNew Jersey08873-5002
Site 007-975-B
Local Institution - 007-975-CSomersetNew Jersey08873-5002
Site 007-975-C
Local Institution - 007-975-DSomersetNew Jersey08873-5002
Site 007-975-D
Holy Name Medical CenterTeaneckNew Jersey07666
Yadyra Rivera, Site 007-784
201-227-6008
New York Oncology Hematology - Albany Medical CenterAlbanyNew York12208
Makenzi Evangelist, Site 007-861
518-489-2607
Local Institution - Unk077RhinebeckNew York12572-
Montefiore Medical CenterThe BronxNew York10467
Balazs Halmos, Site 007-945
718-405-8404
Duke University Medical CenterDurhamNorth Carolina27710
Thomas Stinchcombe, Site 007-946
919-613-2000
Local Institution - 007-893-BCincinnatiOhio45211
Site 007-893-B
Local Institution - 007-893-CCincinnatiOhio45245
Site 007-893-C
USOR - Oncology Hematology Care - Blue AshCincinnatiOhio45242
Patrick Ward, Site 007-893
513-751-2273
University Hospitals Cleveland Medical CenterClevelandOhio44106
Melinda Hsu, Site 007-849
216-286-6505
Mark H. Zangmeister Cancer CenterColumbusOhio43219
Jorge Rios-perez, Site 007-930
502-561-7301
Local Institution - 007-893-AFairfieldOhio45014
Site 007-893-A
Kettering Health Cancer Center - Main CampusKetteringOhio45429
Alejandro Calvo, Site 007-836
855-500-2873
Tricounty Hematology and Oncology - MassillonMassillonOhio44646
Noman Rafique, Site 007-5486
3302686167
USOR - Willamette Valley Cancer Institute and Research Center - EugeneEugeneOregon97401
Bo Wang, Site 007-889
541-683-5001
Local Institution - 007-885APortlandOregon97227
Site 007-885A
Local Institution - 007-885BPortlandOregon97213
Site 007-885B
Oregon Oncology SpecialistsSalemOregon97301
Janelle Meyer, Site 007-967
708-327-3180
Local Institution - 007-885CTigardOregon97223
Site 007-885C
Local Institution - Unk041AllentownPennsylvania18103-6218-
Veterans Affairs Pittsburgh Healthcare System - University Drive CampusPittsburghPennsylvania15240
James Herman, Site 007-5477
4126237769
Local Institution - 007-960ProvidenceRhode Island02903-
Local Institution - Unk038CharlestonSouth Carolina29414-
Local Institution - 007-5475SpartanburgSouth Carolina29303-
Avera Cancer InstituteSioux FallsSouth Dakota57105
Benjamin Solomon, Site 007-940
605-322-6900
Local Institution - 007-928-LDicksonTennessee37055
Site 007-928-L
Local Institution - 007-928-JFranklinTennessee37067
Site 007-928-J
Local Institution - 007-928-GGallatinTennessee37066
Site 007-928-G
West Cancer Center & Research Institute - East CampusGermantownTennessee38138
Ramakrishna Battini, Site 007-916
901-683-0055
Local Institution - 007-928-AHendersonvilleTennessee37075
Site 007-928-A
Local Institution - 007-928-DHermitageTennessee37076
Site 007-928-D
Local Institution - 007-928-HLebanonTennessee37090
Site 007-928-H
Local Institution - 007-928-FMurfreesboroTennessee37129
Site 007-928-F
Local Institution - 007-928-BNashvilleTennessee37203
Site 007-928-B
Local Institution - 007-928-CNashvilleTennessee37211
Site 007-928-C
Local Institution - 007-928-ENashvilleTennessee37207
Site 007-928-E
Local Institution - 007-928-KNashvilleTennessee37205
Site 007-928-K
Tennessee Oncology - Nashville - Centennial Clinic - Medical OncologyNashvilleTennessee37203
Melissa Johnson, Site 007-928
615-329-7274
Local Institution - 007-928-MShelbyvilleTennessee37160
Site 007-928-M
Local Institution - 007-928-ISmyrnaTennessee37167
Site 007-928-I
Local Institution - 007-554BAbileneTexas79606
Site 007-554B
Local Institution - 007-554GAmarilloTexas79124
Site 007-554G
Local Institution - 007-879-AArlingtonTexas76012
Site 007-879-A
Local Institution - 007-879-BArlingtonTexas76014
Site 007-879-B
Local Institution - 007-892-AAustinTexas78731
Site 007-892-A
Local Institution - 007-892-BAustinTexas78705
Site 007-892-B
USOR - Texas Oncology - Dallas Fort Worth (DFW) - South AustinAustinTexas78745
James Uyeki, Site 007-892
512-427-9400
Local Institution - 007-879-CBedfordTexas76022
Site 007-879-C
Local Institution - 007-592DallasTexas75216-
Local Institution - Unk059DallasTexas75204-
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer CenterDallasTexas75246
Kartik Konduri, Site 007-879
214-370-1000
USOR - Texas Oncology Northeast Texas - DenisonDenisonTexas75020
Amir Faridi, Site 007-890
000-000-0000
Local Institution - 007-554CEl PasoTexas79915
Site 007-554C
Local Institution - 007-554EEl PasoTexas79902
Site 007-554E
Local Institution - 007-554FEl PasoTexas79938
Site 007-554F
USOR - Texas Oncology - San Antonio Medical CenterFredericksburgTexas78624
Angel Mier-Hicks, Site 007-927
210-595-5300
Local Institution - 007-848HoustonTexas77030-
Local Institution - 007-999IrvingTexas75063
Site 007-999
Local Institution - 007-890-BLongviewTexas75601
Site 007-890-B
Local Institution - 007-554AMidlandTexas79701
Site 007-554A
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Odessa West Texas Cancer CenterOdessaTexas79761
Pankaj Khandelwal, Site 007-554
000-000-0000
USOR - Texas Oncology - The WoodlandsThe WoodlandsTexas77380
Kruti Sheth Nair, Site 007-894
281-298-8907
Local Institution - 007-890-ATylerTexas75702
Site 007-890-A
Local Institution - 007-554DWichita FallsTexas76310
Site 007-554D
Local Institution - 007-912Salt Lake CityUtah84112-
Local Institution - 007-814-AAlexandriaVirginia22304
Site 007-814-A
Local Institution - 007-814-DArlingtonVirginia22201
Site 007-814-D
USOR - Virginia Cancer Specialists - Fairfax OfficeFairfaxVirginia22031
Alexander Spira, Site 007-814
703-280-5390
Local Institution - 007-814-BGainesvilleVirginia20155
Site 007-814-B
Local Institution - 007-814-CLeesburgVirginia20176
Site 007-814-C
Virginia Cancer Institute - West EndRichmondVirginia23229
Thomas Weart, Site 007-539
804-287-3000
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer CenterVancouverWashington98684
Anthony Van Ho, Site 007-885
503-885-5411
Local Institution - Unk064HuntingtonWest Virginia25705-
Local Institution - Unk057MadisonWisconsin53715-
Local Institution - Unk068MadisonWisconsin53792-

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