Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-12)

January 20, 2025 updated by: Mirati Therapeutics Inc.

A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

453

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Local Institution - 012-005
      • Clayton, Australia, 3168
        • Local Institution - 012-004
      • Douglas, Australia, 4814
        • Townsville University Hospital
      • St. Leonards, Australia, 2065
        • Local Institution - 012-013
      • Tweed Heads, Australia, 2485
        • Local Institution - 012-019
      • Wollongong, Australia, 2500
        • Cancer Care Wollongong
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
    • Queensland
      • Mackay, Queensland, Australia, 4740
        • Local Institution - 012-016
  • Austria
      • Klagenfurt Am Woerthersee, Austria, 9020
        • Klinikum Klagenfurt am Worthersee
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg
      • Wien, Austria, 1160
        • Wiener Gesundheitsverbund - Klinik Ottakring
  • Belgium
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Edegem, Belgium, 2650
        • Local Institution - 012-157
      • Gent, Belgium, 9000
        • Local Institution - 012-155
      • Gilly, Belgium, 6060
        • Local Institution - 012-151
      • Hasselt, Belgium, 3500
        • Local Institution - 012-158
      • Roeselare, Belgium, 8800
        • Local Institution - 012-152
      • Ronse, Belgium, 9600
        • Algemeen Ziekenhuis Glorieux Ronse
      • Yvoir, Belgium, B-5530
        • Local Institution - 012-150
  • Czechia
      • Horovice, Czechia, 268 31
        • Local Institution - 012-164
      • Olomouc, Czechia, 779 00
        • Local Institution - 012-162
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 8 - Liben, Czechia, 180 81
        • Fakultni nemocnice Bulovka
  • France
      • Brest, France, 29200
        • Local Institution - 012-194
      • Bron, France, 69500
        • Hôpital Louis Pradel
      • Caen Cedex 09, France, 14033
        • Local Institution - 012-193
      • Caen Cedex 5, France, 14076
        • Local Institution - 012-196
      • Creteil, France, 94000
        • Centre Hospitalier Intercommunal de Creteil
      • Dijon cedex, France, 21079
        • Local Institution - 012-192
      • Gleize, France, 69400
        • LHopital Nord-Ouest (HNO) - Villefranche-sur-Saone
      • La Tronche, France, 38700
        • Hôpital Michallon
      • Lille Cedex, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille
      • Limoges cedex, France, 87042
        • Centre Hospitalier Universitaire Dupuytren 1
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Marseille, France, 13015
        • Hôpital Nord de Marseille
      • Montpellier, France, 34090
        • Hopital Arnaud de Villeneuve
      • Mulhouse, France, 68100
        • Hôpital Emile Muller
      • Nice Cedex 2, France, 06189
        • Local Institution - 012-685
      • Quimper, France, 29107
        • Centre Hospitalier de Cornouaille - Hopital Laennec
      • Saint Herblain, France, 44805
        • Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau
      • Strasbourg, France, 67200
        • Local Institution - 012-197
      • Strasbourg cedex, France, 67091
        • Hôpital Civil
      • Tours Cedex 9, France, 37044
        • Hopital Bretonneau
      • Villejuif, France, 94805
        • Gustave Roussy
    • Rhone
      • Lyon, Rhone, France, 69004
        • Local Institution - 012-191-B
    • Rhone-Alpes
      • Pierre Benite, Rhone-Alpes, France, 69495
        • Local Institution - 012-191-A
  • Germany
      • Bad Berka, Germany, 99437
        • Local Institution - 012-219
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Essen, Germany, 45136
        • Local Institution - 012-210
      • Gauting, Germany, 82131
        • Local Institution - 012-214
      • Giessen, Germany, 35392
        • Local Institution - 012-671
      • Grohansdorf, Germany, 22927
        • LungenClinic Grosshansdorf
      • Halle, Germany, 06120
        • Local Institution - 012-215
      • Jena, Germany, 07747
        • Universitatsklinikum Jena
      • Kassel, Germany, 34125
        • Klinikum Kassel
      • Koln, Germany, 51109
        • Klinikum Köln-Merheim
      • Lowenstein, Germany, 74245
        • Local Institution - 012-224
      • Lubeck, Germany, 23538
        • Local Institution - 012-216
      • Munchen, Germany, 81925
        • Local Institution - 012-220
      • Offenbach, Germany, 63069
        • Local Institution - 012-672
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg
  • Greece
      • Athens, Greece, 11527
        • Local Institution - 012-236
      • Heraklion, Greece, 71110
        • University General Hospital of Heraklion (PAGNI)
      • Larissa, Greece, 41110
        • Local Institution - 012-235
      • Nea Kifisia, Greece, 145 64
        • "General Oncology Hospital of Kifisias "Agioi Anargyroi""
      • Peiraias, Greece, 185 47
        • Metropolitan Hospital
      • Peiraias, Greece, 185 47
        • Local Institution - 012-234
      • Thessaloniki, Greece, 54622
        • Bioclinic Thessaloniki
      • Thessaloniki, Greece, 57001
        • Local Institution - 012-230
      • Thessaloniki, Greece, 57010
        • Local Institution - 012-500
      • Volos, Greece, 38333
        • Anassa General Clinic
    • Attiki
      • Athens, Attiki, Greece, 11526
        • Henry Dunant Hospital Center
  • Hong Kong
      • Central, Hong Kong
        • Humanity & Health Clinical Trial Centre
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital - Hong Kong
      • Kowloon, Hong Kong
        • Hong Kong United Oncology Centre
  • Hungary
      • Budapest, Hungary, 1083
        • Local Institution - 012-242
      • Budapest, Hungary, 1121
        • Local Institution - 012-244
      • Budapest, Hungary, 1122
        • Local Institution - 012-241
      • Gyongyos, Hungary, 3200
        • Local Institution - 012-243
      • Gyula, Hungary, 5700
        • Local Institution - 012-763
      • Szekesfehervar, Hungary, 8000
        • Local Institution - 012-759
      • Torokbalint, Hungary, 2045
        • Reformatus Pulmonologiai Centrum
  • Ireland
      • Dublin, Ireland, 4
        • St. Vincents University Hospital
      • Dublin, Ireland, 9
        • Beaumont Hospital - Dublin
      • Dublin, Ireland, D08 NHY1
        • St. Jamess Hospital
      • Galway, Ireland, H91 YR71
        • University Hospital Galway
      • Limerick, Ireland, V94 F858
        • University Hospital Limerick
    • Dublin
      • Tallaght, Dublin, Ireland, D24 NR04
        • The Meath Foundation
  • Italy
      • Alessandria, Italy, 15121
        • Local Institution - 012-276
      • Avellino, Italy, 83100
        • Local Institution - 012-292
      • Aviano, Italy, 33081
        • Local Institution - 012-274
      • Bari, Italy, 70124
        • Local Institution - 012-275
      • Brescia, Italy, 25123
        • Local Institution - 012-765
      • Candiolo, Italy, 10060
        • Local Institution - 012-286
      • Catania, Italy, 95122
        • Local Institution - 012-284
      • Catania, Italy, 95123
        • Local Institution - 012-282
      • Firenze, Italy, 50134
        • Local Institution - 012-762
      • Genova, Italy, 16100
        • Local Institution - 012-273
      • Genova, Italy, 16132
        • Local Institution - 012-285
      • Lecce, Italy, 73100
        • Local Institution - 012-279
      • Meldola, Italy, 47014
        • "Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST"
      • Milan, Italy, 20132
        • Local Institution - 012-296
      • Milan, Italy, 20141
        • Local Institution - 012-278
      • Milano, Italy, 20133
        • Local Institution - 012-283
      • Napoli, Italy, 80131
        • Local Institution - 012-271
      • Napoli, Italy, 80131
        • Local Institution - 012-277
      • Novara, Italy, 28100
        • Local Institution - 012-770
      • Parma, Italy, 43126
        • Local Institution - 012-272
      • Perugia, Italy, 06132
        • Local Institution - 012-281
      • Pesaro, Italy, 61122
        • Local Institution - 012-766
      • Ravenna, Italy, 48121
        • Local Institution - 012-767
      • Roma, Italy, 00144
        • Local Institution - 012-295
      • Verona, Italy, 37126
        • Local Institution - 012-758
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Local Institution - 012-111
      • Busan, Korea, Republic of, 602702
        • Local Institution - 012-101
      • Busan-si, Korea, Republic of, 49241
        • Local Institution - 012-522
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Local Institution - 012-110
      • Daegu, Korea, Republic of, 42601
        • Local Institution - 012-523
      • Hwasun-gun, Korea, Republic of, 58128
        • Local Institution - 012-100
      • Incheon, Korea, Republic of, 21565
        • Local Institution - 012-103
      • Jung-Gu, Korea, Republic of, 400-712
        • Local Institution - 012-102
      • Seongnam-si, Korea, Republic of, 13496
        • Local Institution - 012-520
      • Seongnam-si, Korea, Republic of, 13620
        • Local Institution - 012-112
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea - Seoul St. Marys Hospital
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 012-118
      • Seoul, Korea, Republic of, 05080
        • Local Institution - 012-106
      • Suwon-Si, Korea, Republic of, 16247
        • Catholic University of Korea St. Vincents Hospital
      • Suwon-si, Korea, Republic of, 16499
        • Local Institution - 012-107
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution - 012-306
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis - Breda Molengracht
      • Den Haag, Netherlands, 2545 AA
        • Local Institution - 012-308
      • Maastricht, Netherlands, 6229 HX
        • Local Institution - 012-300
      • Nijmegen, Netherlands, 6525 GA
        • Local Institution - 012-630
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
      • Utrecht, Netherlands, 3543 AZ
        • Local Institution - 012-307
  • Poland
      • Lodz, Poland, 90-302
        • Instytut MSF
      • Lublin, Poland, 20-064
        • Local Institution - 012-321
      • Lublin, Poland, 20-093
        • Local Institution - 012-760
      • Otwock, Poland, 05-400
        • Local Institution - 012-325
      • Rzeszow, Poland, 35-922
        • Local Institution - 012-320
      • Skorzewo, Poland, 60-185
        • Local Institution - 012-324
      • Torun, Poland, 87-100
        • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
      • Warsaw, Poland, 04-349
        • Wojskowy Instytut Medyczny
      • Warszawa, Poland, 02-781
        • Local Institution - 012-322
  • Portugal
      • Almada, Portugal, 2805-267
        • Unidade Local de Saude de Almada-Seixal, E. P. E (Hospital Garcia de Orta)
      • Braga, Portugal, 4710-243
        • Unidade Local de Saúde de Braga, E. P. E (Hospital de Braga)
      • Coimbra, Portugal, 3000-075
        • Local Institution - 012-330
      • Coimbra, Portugal, 3000-075
        • Local Institution - 012-645
      • Guimaraes, Portugal, 4835-044
        • Local Institution - 012-333
      • Lisboa, Portugal, 1350-352
        • Local Institution - 012-338-A
      • Lisbon, Portugal, 1400-038
        • The Champalimaud Centre for the Unknown
      • Lisbon, Portugal, 1099-023
        • Local Institution - 012-642
      • Lisbon, Portugal, 1998-018
        • Local Institution - 012-338
      • Loures, Portugal, 2674-514
        • Unidade Local de Saude de Loures-Odivelas, EPE (Hospital Beatriz Angelo)
      • Porto, Portugal, 14341
        • Hospital Cuf porto
      • Porto, Portugal, 4099-001
        • Local Institution - 012-331
      • Porto, Portugal, 4200-072
        • Local Institution - 012-339
      • Santa Maria Da Feira, Portugal, 4520-211
        • Unidade Local de Saude de Entre Douro e Vouga, E. P. E
      • Setubal, Portugal, 2910-443
        • Unidade Local de Saude da Arrabida, E. P. E (Centro Hospitalar de Setubal)
      • Vila Nova de Gaia, Portugal, 4434-502
        • Unidade Local de Saúde de Gaia/Espinho, E. P. E
  • Puerto Rico
      • San Juan, Puerto Rico, 00919
        • Puerto Rico Medical Research Center
      • San Juan, Puerto Rico, 00935
        • PanOncology Trials - Rio Piedras Medical Center
      • San Juan, Puerto Rico, 00927
        • FDI Clinical Research (Fundacion de Investigacion de Diego) - San Juan
  • Romania
      • Baia Mare, Romania, 430031
        • Spitalul Jude�ean de Urgen�a dr. Constantin Opri� Baia Mare
      • Brașov, Romania, 500152
        • SC Policlinica de Diagnostic Rapid SA
      • Bucharest, Romania, 022328
        • Local Institution - 012-342
      • București, Romania, 010991
        • Centrul Oncologic Sanador
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 012-344
      • Cluj-Napoca, Romania, 400641
        • Local Institution - 012-340
      • Craiova, Romania, 200385
        • Oncolab Craiova
      • Craiova, Romania, 200746
        • Local Institution - 012-343
      • Iasi, Romania, 700106
        • Local Institution - 012-513
      • Ovidiu, Romania, 905900
        • Ovidius Clinical Hospital
      • Timisoara, Romania, 300239
        • SC Oncomed SRL
      • Timișoara, Romania, 300166
        • Oncocenter - Oncologie Clinica
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454048
        • Evimed Oncology Clinic
      • Izhevsk, Russian Federation, 426067
        • "Budgetary Healthcare Institution of the Udmurt Republic "Republican Clinical Oncological Dispensary n.a. Sergey Grigoryevich Pr
      • Kislino Village, Russian Federation, 305524
        • "Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical Center" of the Healthcare C
      • Moscow, Russian Federation, 121467
        • University Headache Clinic
      • Moscow, Russian Federation, 121309
        • VitaMed - Moscow
      • Nizhniy Novgorod, Russian Federation, 603006
        • State Budgetary Healthcare Institution of the Nizhny Novgorod Region Clinical Diagnostic Center
      • Novosibirsk, Russian Federation, 630099
        • "Limited Liability Company Medical Sanitary Unit "Clinicist-Clinic Pretor""
      • Omsk, Russian Federation, 644013
        • "Budgetary Healthcare Institution of Omsk region "Clinical Oncologic Dispensary""
      • Saint Petersburg, Russian Federation, 197022
        • Local Institution - 012-355
      • Saint Petersburg, Russian Federation, 197758
        • Local Institution - 012-354
      • Saint-Petersburg, Russian Federation, 197376
        • "Federal State Budgetary Institution "Influenza Research Institute named after N.N. A.A. Smorodintsev" of the Ministry of Health
  • Singapore
      • Singapore, Singapore, 188770
        • Raffles Hospital
      • Singapore, Singapore, 258499
        • Oncocare Cancer Centre
      • Singapore, Singapore, 217562
        • Icon Cancer Centre Farrer Park
      • Singapore, Singapore, 258500
        • Parkway Cancer Centre - Gleneagles Hospital
      • Singapore, Singapore, 168583
        • Local Institution - 012-093
  • Spain
      • A Coruna, Spain, 15006
        • Local Institution - 012-613
      • Alicante, Spain, 3010
        • Local Institution - 012-769
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barakaldo, Spain, 48903
        • Local Institution - 012-776
      • Barcelona, Spain, 08003
        • Hospital del Mar - Parc de Salut Mar
      • Barcelona, Spain, 08028
        • Local Institution - 012-614
      • Barcelona, Spain, 08035
        • Local Institution - 012-612
      • Barcelona, Spain, 08036
        • Local Institution - 012-600
      • Cordoba, Spain, 14004
        • Local Institution - 012-621
      • Girona, Spain, 17007
        • Local Institution - 012-764
      • Granada, Spain, 18014
        • Local Institution - 012-616
      • Las Palmas de Gran Canaria, Spain, 35016
        • Complejo Hospitalario Universitario Insular Materno Infantil
      • Leon, Spain, 24071
        • Hospital de Leon
      • Lugo, Spain, 27003
        • Local Institution - 012-615
      • Madrid, Spain, 28027
        • Clínica Universidad de Navarra - Madrid
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Local Institution - 012-607
      • Madrid, Spain, 28034
        • Local Institution - 012-606
      • Madrid, Spain, 28040
        • Local Institution - 012-601
      • Madrid, Spain, 28040
        • Local Institution - 012-609
      • Majadahonda, Spain, 28222
        • Local Institution - 012-626
      • Malaga, Spain, 29009
        • Local Institution - 012-608
      • Palma de Mallorca, Spain, 07120
        • Local Institution - 012-602
      • Santander, Spain, 39008
        • Local Institution - 012-604
      • Sevilla, Spain, 41013
        • Local Institution - 012-629
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46014
        • Consorci Hospital General Universitari de València
      • Zaragoza, Spain, 50009
        • Local Institution - 012-603
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitatsspital Basel
      • Thun, Switzerland, 3604
        • Spital Simmental-Thun-Saanenland
      • Winterthur, Switzerland, 8401
        • Kantonsspital Winterthur
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • University Hospitals Birmingham NHS Foundation Trust
      • Edinburgh, United Kingdom, EH4 2XU
        • NHS Lothian
      • Glasgow, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals Of Leicester Nhs Trust
      • Manchester, United Kingdom, M20 4BX
        • The Christie Nhs Foundation Trust
  • United States
    • California
      • Cerritos, California, United States, 90703
        • Local Institution - 012-898
      • Duarte, California, United States, 91010
        • City of Hope - Duarte (Main Campus)
      • Glendale, California, United States, 91204
        • Local Institution - 012-898 D
      • Huntington Beach, California, United States, 92648
        • Local Institution - 012-910-A
      • Irvine, California, United States, 92618
        • Local Institution - 012-910-C
      • Long Beach, California, United States, 90808
        • City of Hope
      • Long Beach, California, United States, 90813
        • Local Institution - 012-910-F
      • Newport Beach, California, United States, 92663
        • Local Institution - 012-910-D
      • Santa Ana, California, United States, 92705
        • Local Institution - 012-898 C
      • Santa Rosa, California, United States, 95403
        • Providence Medical Group - Santa Rosa
      • Torrance, California, United States, 90505
        • Local Institution - 012-910-E
    • Colorado
      • Denver, Colorado, United States, 80218
        • Local Institution - 012-951-B
      • Lafayette, Colorado, United States, 80026
        • SCL Health - Saint Joseph Hospital Cancer Center
      • Lone Tree, Colorado, United States, 80124
        • Local Institution - 012-872
      • Wheat Ridge, Colorado, United States, 80033-6005
        • Local Institution - 012-951-A
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Local Institution - 012-562-B
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Health Fort Lauderdale - Holy Cross Hospital
      • Jacksonville, Florida, United States, 32204
        • 21st Century Oncology of Jacksonville - North Lee Street
      • Jacksonville, Florida, United States, 32204
        • Local Institution - 012-562-D
      • Jacksonville, Florida, United States, 32207
        • Local Institution - 012-562-E
      • Jacksonville, Florida, United States, 32256
        • Local Institution - 012-562-A
      • Jacksonville, Florida, United States, 32256
        • Local Institution - 012-562-C
      • Jacksonville, Florida, United States, 32256
        • Local Institution - 012-562-F
      • Jacksonville, Florida, United States, 32256
        • Local Institution - 012-562-G
      • Jacksonville, Florida, United States, 32256
        • Local Institution - 012-562
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
        • Orlando Health University of Florida Health Cancer Center - Head and Neck Center
      • Pensacola, Florida, United States, 32503
        • USOR - Woodlands Medical Specialists
      • Plantation, Florida, United States, 33322
        • Local Institution - 012-839
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center (UCBC) - Athens
      • Austell, Georgia, United States, 30106
        • Local Institution - 012-835 - A
      • Carrollton, Georgia, United States, 30117
        • Local Institution - 012-835 - B
      • Cartersville, Georgia, United States, 30121
        • Local Institution - 012-835 - C
      • Douglasville, Georgia, United States, 30134
        • Local Institution - 012-835 - D
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers Wellstar - Marietta
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital & Health Sciences System
      • Harvey, Illinois, United States, 60426
        • Local Institution - 012-972 C
      • New Lenox, Illinois, United States, 60451
        • Local Institution - 012-972 A
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists - Niles
      • Orland Park, Illinois, United States, 60462
        • Local Institution - 012-972 B
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
      • Indianapolis, Indiana, United States, 46237
        • Local Institution - 012-569
      • Lafayette, Indiana, United States, 47905
        • Local Institution - 012-569 - B
      • Lafayette, Indiana, United States, 47905
        • Local Institution - 012-569 - C
      • Mooresville, Indiana, United States, 46158
        • Local Institution - 012-569 - A
      • Munster, Indiana, United States, 46321
        • Franciscan Health Munster
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Local Institution - 012-942-B
      • Dodge City, Kansas, United States, 67801
        • Local Institution - 012-942-C
      • El Dorado, Kansas, United States, 67042
        • Local Institution - 012-942-D
      • Independence, Kansas, United States, 67301
        • Local Institution - 012-942-E
      • Kingman, Kansas, United States, 67068
        • Local Institution - 012-942-F
      • Liberal, Kansas, United States, 67901
        • Local Institution - 012-942-G
      • McPherson, Kansas, United States, 67460
        • Local Institution - 012-942-H
      • Newton, Kansas, United States, 67114
        • Local Institution - 012-942-I
      • Parsons, Kansas, United States, 67357
        • Local Institution - 012-942-J
      • Pratt, Kansas, United States, 67124
        • Local Institution - 012-942-K
      • Salina, Kansas, United States, 67401
        • Local Institution - 012-942-L
      • Wellington, Kansas, United States, 67152
        • Local Institution - 012-942-M
      • Westwood, Kansas, United States, 66205
        • Local Institution - 012-820
      • Wichita, Kansas, United States, 67208
        • Local Institution - 012-942-A
      • Wichita, Kansas, United States, 67214
        • Local Institution - 012-942
      • Winfield, Kansas, United States, 67156
        • Local Institution - 012-942-N
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
      • New Orleans, Louisiana, United States, 70112
        • Local Institution - 012-911 A
    • Maine
      • Kennebunk, Maine, United States, 04043
        • Local Institution - 012-954 - A
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists - Scarborough
      • Topsham, Maine, United States, 04086
        • Local Institution - 012-954 - B
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Frederick Health
    • Michigan
      • Novi, Michigan, United States, 48374
        • Local Institution - 012-974-B
      • Novi, Michigan, United States, 48374
        • Local Institution - 012-974-C
      • Southfield, Michigan, United States, 48075
        • Ascension Providence Cancer Center - Southfield
      • Southfield, Michigan, United States, 48075
        • Local Institution - 012-974-A
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
    • Montana
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare Cancer Centers of Montana
      • Billings, Montana, United States, 59102
        • Sisters of Charity of Leavenworth Health St. Marys
      • Billings, Montana, United States, 59101
        • Local Institution - 012-841 - A
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Astera Cancer Care - East Brunswick
      • Edison, New Jersey, United States, 08820
        • Local Institution - 012-975 - A
      • Monroe, New Jersey, United States, 08831
        • Local Institution - 012-975 - B
      • Somerset, New Jersey, United States, 08873
        • Local Institution - 012-975 - C
      • Somerville, New Jersey, United States, 08876
        • Local Institution - 012-975 - D
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • New York
      • Syracuse, New York, United States, 13210-2306
        • SUNY Upstate Medical University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Kettering, Ohio, United States, 45429
        • Kettering Health Cancer Center - Main Campus
    • Oregon
      • Salem, Oregon, United States, 97301
        • Oregon Oncology Specialists
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Lifespan Cancer Institute - Rhode Island Hospital
      • Providence, Rhode Island, United States, 02906
        • Local Institution - 012-960-A
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris Road
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Oncology - Dallas Fort Worth (DFW) - Arlington Cancer Center North
      • Austin, Texas, United States, 78745
        • Texas Oncology - Dallas Fort Worth (DFW) - South Austin
      • Irving, Texas, United States, 75063
        • US Oncology Research (USOR)
      • Sherman, Texas, United States, 75090
        • Texas Oncology - Sherman
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists - UCS Cancer Center
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-A
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-B
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-C
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-D
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-E
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-F
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-G
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-H
      • Salt Lake City, Utah, United States, 84124
        • Local Institution - 012-976-I
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Local Institution - 012-814 - B
      • Charlottesville, Virginia, United States, 22908-0674
        • UVA Health - University Hospital
      • Fairfax, Virginia, United States, 22031
        • NEXT Virginia
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 012-814 - A
      • Gainesville, Virginia, United States, 20155
        • Local Institution - 012-814 - C
      • Leesburg, Virginia, United States, 20176
        • Local Institution - 012-814 - D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
  • Candidacy to receive treatment with docetaxel.

Crossover Inclusion Criteria:

  • Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
  • ECOG performance status 0-2

Exclusion Criteria:

  • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
  • Active brain metastases.

Crossover Exclusion Criteria:

  • Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docetaxel
Drug: Docetaxel
21 day cycles
Other Names:
  • Taxotere
Experimental: MRTX849
Drug: MRTX849
21 day cycles
Other Names:
  • adagrasib
  • KRAZATI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Per Blinded Independent Central Review
Time Frame: From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization till death due to any cause (up to approximately 143 weeks)
Overall survival is defined as the time from randomization to the date of death due to any cause.
From randomization till death due to any cause (up to approximately 143 weeks)
Objective Response Rate (ORR) as Per Blinded Independent Central Review
Time Frame: From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)
Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)
Duration of Response (DOR) as Per Blinded Independent Central Review
Time Frame: First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)
1-Year Survival Rate
Time Frame: Up to 49 months
Up to 49 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters
Time Frame: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Blood samples were collected to assess hematology parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters
Time Frame: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Blood samples were collected to assess chemistry parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Plasma Concentration of Adagrasib
Time Frame: Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)
Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms.
Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)
Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score
Time Frame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Least Square Mean and Confidence Interval are from a repeated measures model on the response variable change from baseline in LCSS average total score.
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score
Time Frame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score.
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score
Time Frame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score.
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score
Time Frame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points.
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score
Time Frame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index.
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirati Therapeutics Inc.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

December 30, 2023

Study Completion (Estimated)

July 2, 2026

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA239-0013 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • 849-012 (Other Identifier: Mirati Therapeutics Protocol ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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