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

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: Advanced Non Small Cell Lung Cancer; Metastatic Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: MRTX849

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 3

Expanded Access

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

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia, 5042
    • Local Institution - 012-005
  • Clayton, Australia, 3168
    • Local Institution - 012-004
  • Douglas, Australia, 4814
    • Local Institution - 012-014
  • St Leonards, Australia, 2065
    • Local Institution - 012-013
  • Tweed Heads, Australia, 2485
    • Local Institution - 012-019
  • Wollongong, Australia, 2500
    • Local Institution - 012-017
  • Woolloongabba, Australia, 4102
    • Local Institution - 012-009
  • Queensland
    • Mackay, Queensland, Australia, 4740
      • Local Institution - 012-016
• Austria
  • Klagenfurt, Austria, 9020
    • Local Institution - 012-142
  • Salzburg, Austria, 5020
    • Local Institution - 012-140
  • Vienna, Austria, 1160
    • Local Institution - 012-146
• Belgium
  • Brussels, Belgium, 1090
    • Local Institution - 012-154
  • Edegem, Belgium, 2650
    • Local Institution - 012-157
  • Ghent, 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
    • Local Institution - 012-153
  • Yvoir, Belgium, B-5530
    • Local Institution - 012-150
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100039
      • Local Institution - 012-725
    • Beijing, Beijing Municipality, China, 100142
      • Local Institution - 012-700
    • Beijing, Beijing Municipality, China, 100142
      • Local Institution - 012-738
    • Beijing, Beijing Municipality, China, 100730
      • Local Institution - 012-724
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400038
      • Local Institution - 012-727
    • Chongqing, Chongqing Municipality, China, 400042
      • Local Institution - 012-726
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Local Institution - 012-029
    • Xiamen, Fujian, China, 361003
      • Local Institution - 012-732
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Local Institution - 012-712
    • Guangzhou, Guangdong, China, 510515
      • Local Institution - 012-739
  • Guangxi
    • Liuzhou, Guangxi, China, 545006
      • Local Institution - 012-733
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Local Institution - 012-028
  • Henan
    • Xinxiang, Henan, China, 453100
      • Local Institution - 012-740
    • Zhengzhou, Henan, China, 450008
      • Local Institution - 012-021
    • Zhengzhou, Henan, China, 450052
      • Local Institution - 012-730
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution - 012-023
    • Wuhan, Hubei, China, 430079
      • Local Institution - 012-701
  • Hunan
    • Changsha, Hunan, China, 410006
      • Local Institution - 012-702
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Local Institution - 012-735
    • Nanjing, Jiangsu, China, 210008
      • Local Institution - 012-734
    • Nanjing, Jiangsu, China, 210029
      • Local Institution - 012-729
    • Xuzhou, Jiangsu, China, 221009
      • Local Institution - 012-728
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 012-706
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 012-731
  • Jilin
    • Changchun, Jilin, China, 130012
      • Local Institution - 012-030
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Local Institution - 012-709
  • Shandong
    • Jinan, Shandong, China, 250117
      • Local Institution - 012-036
    • Linyi, Shandong, China, 276001
      • Local Institution - 012-737
    • Qingdao, Shandong, China, 266555
      • Local Institution - 012-741
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Local Institution - 012-719
    • Shanghai, Shanghai Municipality, China, 200032
      • Local Institution - 012-024
    • Shanghai, Shanghai Municipality, China, 200032
      • Local Institution - 012-025
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 012-710
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 012-721
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution - 012-722
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution - 012-736
    • Hangzhou, Zhejiang, China, 310022
      • Local Institution - 012-034
• Czechia
  • Hořovice, Czechia, 268 31
    • Local Institution - 012-164
  • Olomouc, Czechia, 779 00
    • Local Institution - 012-162
  • Prague, Czechia, 128 08
    • Local Institution - 012-163
  • Praha 8 - Liben, Czechia, 180 81
    • Local Institution - 012-168
• France
  • Brest, France, 29200
    • Local Institution - 012-194
  • Bron, France, 69500
    • Local Institution - 012-191
  • Caen, France, 14033
    • Local Institution - 012-193
  • Caen, France, 14076
    • Local Institution - 012-196
  • Créteil, France, 94000
    • Local Institution - 012-190
  • Dijon, France, 21079
    • Local Institution - 012-192
  • Gleizé, France, 69400
    • Local Institution - 012-201
  • La Tronche, France, 38700
    • Local Institution - 012-683
  • Lille, France, 59037
    • Local Institution - 012-665
  • Limoges, France, 87042
    • Local Institution - 012-195
  • Marseille, France, 13009
    • Local Institution - 012-199
  • Marseille, France, 13015
    • Local Institution - 012-687
  • Montpellier, France, 34090
    • Local Institution - 012-200
  • Mulhouse, France, 68100
    • Local Institution - 012-666
  • Nice, France, 06189
    • Local Institution - 012-685
  • Quimper, France, 29107
    • Local Institution - 012-681
  • Saint-Herblain, France, 44805
    • Local Institution - 012-198
  • Strasbourg, France, 67200
    • Local Institution - 012-197
  • Strasbourg, France, 67091
    • Local Institution - 012-684
  • Tours, France, 37044
    • Local Institution - 012-209
  • Villejuif, France, 94805
    • Local Institution - 012-202
  • Auvergne-Rhône-Alpes
    • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
      • Local Institution - 012-191-A
  • Rhone
    • Lyon, Rhone, France, 69004
      • Local Institution - 012-191-B
• Germany
  • Bad Berka, Germany, 99437
    • Local Institution - 012-219
  • Bonn, Germany, 53127
    • Local Institution - 012-222
  • Cologne, Germany, 51109
    • Local Institution - 012-221
  • Essen, Germany, 45136
    • Local Institution - 012-210
  • Gauting, Germany, 82131
    • Local Institution - 012-214
  • Giessen, Germany, 35392
    • Local Institution - 012-671
  • Grohansdorf, Germany, 22927
    • Local Institution - 012-659
  • Halle, Germany, 06120
    • Local Institution - 012-215
  • Jena, Germany, 07747
    • Local Institution - 012-225
  • Kassel, Germany, 34125
    • Local Institution - 012-213
  • Löwenstein, Germany, 74245
    • Local Institution - 012-224
  • Lübeck, Germany, 23538
    • Local Institution - 012-216
  • München, Germany, 81925
    • Local Institution - 012-220
  • Offenbach, Germany, 63069
    • Local Institution - 012-672
  • Oldenburg, Germany, 26121
    • Local Institution - 012-212
• 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 Kifissia, Greece, 145 64
    • Local Institution - 012-237
  • Piraeus, Greece, 185 47
    • Local Institution - 012-234
  • Piraeus, Greece, 185 47
    • Local Institution - 012-239
  • Thessaloniki, Greece, 57001
    • Local Institution - 012-230
  • Thessaloniki, Greece, 57010
    • Local Institution - 012-500
  • Thessaloniki, Greece, 54622
    • Local Institution - 012-504
  • Volos, Greece, 38333
    • Local Institution - 012-503
  • Attica
    • Athens, Attica, Greece, 11526
      • Local Institution - 012-502
• Hong Kong
  • Central, Hong Kong
    • Local Institution - 012-048
  • Hong Kong, Hong Kong
    • Local Institution - 012-043
  • Kowloon, Hong Kong
    • Local Institution - 012-040
• Hungary
  • Budapest, Hungary, 1083
    • Local Institution - 012-242
  • Budapest, Hungary, 1121
    • Local Institution - 012-244
  • Budapest, Hungary, 1122
    • Local Institution - 012-241
  • Gyula, Hungary, 5700
    • Local Institution - 012-763
  • Gyöngyös, Hungary, 3200
    • Local Institution - 012-243
  • Székesfehérvár, Hungary, 8000
    • Local Institution - 012-759
  • Törökbálint, Hungary, 2045
    • Local Institution - 012-240
• Ireland
  • Dublin, Ireland, 4
    • Local Institution - 012-250
  • Dublin, Ireland, 9
    • Local Institution - 012-252
  • Dublin, Ireland, D08 NHY1
    • Local Institution - 012-259
  • Galway, Ireland, H91 YR71
    • Local Institution - 012-257
  • Limerick, Ireland, V94 F858
    • Local Institution - 012-258
  • Dublin
    • Tallaght, Dublin, Ireland, D24 NR04
      • Local Institution - 012-255
• 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
  • Florence, 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
    • Local Institution - 012-270
  • Milan, Italy, 20132
    • Local Institution - 012-296
  • Milan, Italy, 20141
    • Local Institution - 012-278
  • Milan, Italy, 20133
    • Local Institution - 012-283
  • Naples, Italy, 80131
    • Local Institution - 012-271
  • Naples, 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
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Local Institution - 012-306
  • Breda, Netherlands, 4818 CK
    • Local Institution - 012-309
  • Maastricht, Netherlands, 6229 HX
    • Local Institution - 012-300
  • Nijmegen, Netherlands, 6525 GA
    • Local Institution - 012-630
  • The Hague, Netherlands, 2545 AA
    • Local Institution - 012-308
  • Utrecht, Netherlands, 3543 AZ
    • Local Institution - 012-307
  • Utrecht, Netherlands, 3584 CX
    • Local Institution - 012-631
• Poland
  • Lodz, Poland, 90-302
    • Local Institution - 012-757
  • Lublin, Poland, 20-064
    • Local Institution - 012-321
  • Lublin, Poland, 20-093
    • Local Institution - 012-760
  • Otwock, Poland, 05-400
    • Local Institution - 012-325
  • Rzeszów, Poland, 35-922
    • Local Institution - 012-320
  • Skorzewo, Poland, 60-185
    • Local Institution - 012-324
  • Torun, Poland, 87-100
    • Local Institution - 012-329
  • Warsaw, Poland, 02-781
    • Local Institution - 012-322
  • Warsaw, Poland, 04-349
    • Local Institution - 012-774
• Portugal
  • Almada, Portugal, 2805-267
    • Local Institution - 012-644
  • Braga, Portugal, 4710-243
    • Local Institution - 012-332
  • Coimbra, Portugal, 3000-075
    • Local Institution - 012-330
  • Coimbra, Portugal, 3000-075
    • Local Institution - 012-645
  • Guimarães, Portugal, 4835-044
    • Local Institution - 012-333
  • Lisbon, Portugal, 1099-023
    • Local Institution - 012-642
  • Lisbon, Portugal, 1998-018
    • Local Institution - 012-338
  • Lisbon, Portugal, 1350-352
    • Local Institution - 012-338-A
  • Lisbon, Portugal, 1400-038
    • Local Institution - 012-337
  • Loures, Portugal, 2674-514
    • Local Institution - 012-647
  • Porto, Portugal, 4099-001
    • Local Institution - 012-331
  • Porto, Portugal, 4200-072
    • Local Institution - 012-339
  • Porto, Portugal, 14341
    • Local Institution - 012-334
  • Santa Maria da Feira, Portugal, 4520-211
    • Local Institution - 012-641
  • Setúbal, Portugal, 2910-443
    • Local Institution - 012-646
  • Vila Nova de Gaia, Portugal, 4434-502
    • Local Institution - 012-335
• Puerto Rico
  • San Juan, Puerto Rico, 00919
    • Local Institution - 012-901
  • PR
    • San Juan, PR, Puerto Rico, 00927
      • Local Institution - 012-903
    • San Juan, PR, Puerto Rico, 00935
      • Local Institution - 012-900
• Romania
  • Baia Mare, Romania, 430031
    • Local Institution - 012-347
  • Brasov, Romania, 500152
    • Local Institution - 012-349
  • Bucharest, Romania, 022328
    • Local Institution - 012-342
  • Bucharest, Romania, 010991
    • Local Institution - 012-341
  • Cluj-Napoca, Romania, 400015
    • Local Institution - 012-344
  • Cluj-Napoca, Romania, 400641
    • Local Institution - 012-340
  • Craiova, Romania, 200746
    • Local Institution - 012-343
  • Craiova, Romania, 200385
    • Local Institution - 012-514
  • Iași, Romania, 700106
    • Local Institution - 012-513
  • Ovidiu, Romania, 905900
    • Local Institution - 012-519
  • Timișoara, Romania, 300166
    • Local Institution - 012-515
  • Timișoara, Romania, 300239
    • Local Institution - 012-345
• Russia
  • Chelyabinsk, Russia, 454048
    • Local Institution - 012-352
  • Izhevsk, Russia, 426067
    • Local Institution - 012-351
  • Kislino Village, Russia, 305524
    • Local Institution - 012-362
  • Moscow, Russia, 121309
    • Local Institution - 012-353
  • Moscow, Russia, 121467
    • Local Institution - 012-368
  • Nizhny Novgorod, Russia, 603006
    • Local Institution - 012-359
  • Novosibirsk, Russia, 630099
    • Local Institution - 012-356
  • Omsk, Russia, 644013
    • Local Institution - 012-350
  • Saint Petersburg, Russia, 197022
    • Local Institution - 012-355
  • Saint Petersburg, Russia, 197376
    • Local Institution - 012-358
  • Saint Petersburg, Russia, 197758
    • Local Institution - 012-354
• Singapore
  • Singapore, Singapore, 168583
    • Local Institution - 012-093
  • Singapore, Singapore, 188770
    • Local Institution - 012-095
  • Singapore, Singapore, 217562
    • Local Institution - 012-092
  • Singapore, Singapore, 258499
    • Local Institution - 012-091
  • Singapore, Singapore, 258500
    • Local Institution - 012-094
• South Korea
  • Busan, South Korea, 48108
    • Local Institution - 012-111
  • Busan, South Korea, 49241
    • Local Institution - 012-522
  • Busan, South Korea, 602702
    • Local Institution - 012-101
  • Cheongju-si, South Korea, 28644
    • Local Institution - 012-113
  • Daegu, South Korea, 41404
    • Local Institution - 012-110
  • Daegu, South Korea, 42601
    • Local Institution - 012-523
  • Hwasun-gun, South Korea, 58128
    • Local Institution - 012-100
  • Incheon, South Korea, 21565
    • Local Institution - 012-103
  • Junggu, South Korea, 400-712
    • Local Institution - 012-102
  • Seongnam-si, South Korea, 13496
    • Local Institution - 012-520
  • Seongnam-si, South Korea, 13620
    • Local Institution - 012-112
  • Seoul, South Korea, 02841
    • Local Institution - 012-105
  • Seoul, South Korea, 03722
    • Local Institution - 012-118
  • Seoul, South Korea, 05080
    • Local Institution - 012-106
  • Seoul, South Korea, 05505
    • Local Institution - 012-104
  • Seoul, South Korea, 06591
    • Local Institution - 012-109
  • Suwon, South Korea, 16247
    • Local Institution - 012-521
  • Suwon, South Korea, 16499
    • Local Institution - 012-107
• Spain
  • A Coruña, Spain, 15006
    • Local Institution - 012-613
  • Alicante, Spain, 3010
    • Local Institution - 012-769
  • Badalona, Spain, 08916
    • Local Institution - 012-610
  • Barakaldo, Spain, 48903
    • Local Institution - 012-776
  • Barcelona, Spain, 08028
    • Local Institution - 012-614
  • Barcelona, Spain, 08035
    • Local Institution - 012-612
  • Barcelona, Spain, 08036
    • Local Institution - 012-600
  • Barcelona, Spain, 08003
    • Local Institution - 012-761
  • Córdoba, 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
    • Local Institution - 012-628
  • León, Spain, 24071
    • Local Institution - 012-775
  • Lugo, Spain, 27003
    • Local Institution - 012-615
  • 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
  • Madrid, Spain, 28027
    • Local Institution - 012-611
  • Madrid, Spain, 28041
    • Local Institution - 012-617
  • Majadahonda, Spain, 28222
    • Local Institution - 012-626
  • Málaga, Spain, 29009
    • Local Institution - 012-608
  • Palma de Mallorca, Spain, 07120
    • Local Institution - 012-602
  • Santander, Spain, 39008
    • Local Institution - 012-604
  • Seville, Spain, 41013
    • Local Institution - 012-629
  • Valencia, Spain, 46014
    • Local Institution - 012-625
  • Valencia, Spain, 46026
    • Local Institution - 012-605
  • Zaragoza, Spain, 50009
    • Local Institution - 012-603
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Local Institution - 012-611A
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution - 012-390
  • Thun, Switzerland, 3604
    • Local Institution - 012-391
  • Winterthur, Switzerland, 8401
    • Local Institution - 012-392
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Local Institution - 012-401
  • Edinburgh, United Kingdom, EH4 2XU
    • Local Institution - 012-415
  • Glasgow, United Kingdom, G12 0XH
    • Local Institution - 012-400
  • Leicester, United Kingdom, LE1 5WW
    • Local Institution - 012-408
  • Manchester, United Kingdom, M20 4BX
    • Local Institution - 012-407
• United States
  • California
    • Cerritos, California, United States, 90703
      • Local Institution - 012-898
    • Duarte, California, United States, 91010
      • Local Institution - 012-910
    • 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, 90813
      • Local Institution - 012-910-F
    • Long Beach, California, United States, 90808
      • Local Institution - 012-910-B
    • 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
      • Local Institution - 012-858
    • 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
      • Local Institution - 012-951
    • 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
      • Local Institution - 012-968
    • 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
    • Jacksonville, Florida, United States, 32204
      • Local Institution - 012-853
    • Miami Beach, Florida, United States, 33140
      • Local Institution - 012-825
    • Orlando, Florida, United States, 32806
      • Local Institution - 012-973
    • Pensacola, Florida, United States, 32503
      • Local Institution - 012-877
    • Plantation, Florida, United States, 33322
      • Local Institution - 012-839
  • Georgia
    • Athens, Georgia, United States, 30607
      • Local Institution - 012-941
    • 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
      • Local Institution - 012-835
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Local Institution - 012-917
    • Chicago, Illinois, United States, 60637
      • Local Institution - 012-972
    • 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
      • Local Institution - 012-883
    • Orland Park, Illinois, United States, 60462
      • Local Institution - 012-972 B
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Local Institution - 012-943
    • 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
      • Local Institution - 012-782
  • 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
      • Local Institution - 012-965
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Local Institution - 012-911 A
    • New Orleans, Louisiana, United States, 70112
      • Local Institution - 012-911
  • Maine
    • Kennebunk, Maine, United States, 04043
      • Local Institution - 012-954 - A
    • Scarborough, Maine, United States, 04074
      • Local Institution - 012-954
    • Topsham, Maine, United States, 04086
      • Local Institution - 012-954 - B
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Local Institution - 012-856
  • 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
      • Local Institution - 012-974-A
    • Southfield, Michigan, United States, 48075
      • Local Institution - 012-974
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Local Institution - 012-952
  • Montana
    • Billings, Montana, United States, 59101
      • Local Institution - 012-841 - A
    • Billings, Montana, United States, 59101
      • Local Institution - 012-841
    • Billings, Montana, United States, 59102
      • Local Institution - 012-846
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Local Institution - 012-975
    • 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
      • Local Institution - 012-577
  • New York
    • Syracuse, New York, United States, 13210-2306
      • Local Institution - 012-962
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Local Institution - 012-849
    • Kettering, Ohio, United States, 45429
      • Local Institution - 012-836
  • Oregon
    • Salem, Oregon, United States, 97301
      • Local Institution - 012-967
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Local Institution - 012-960-A
    • Providence, Rhode Island, United States, 02903
      • Local Institution - 012-960
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Local Institution - 012-891
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Local Institution - 012-940
  • Texas
    • Arlington, Texas, United States, 76012
      • Local Institution - 012-888
    • Austin, Texas, United States, 78745
      • Local Institution - 012-892
    • Irving, Texas, United States, 75063
      • Local Institution - 012-999
    • Sherman, Texas, United States, 75090
      • Local Institution - 012-890
  • Utah
    • 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
    • Salt Lake City, Utah, United States, 84106
      • Local Institution - 012-976
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Local Institution - 012-814 - B
    • Charlottesville, Virginia, United States, 22908-0674
      • Local Institution - 012-953
    • Fairfax, Virginia, United States, 22031
      • Local Institution - 012-814 - A
    • Fairfax, Virginia, United States, 22031
      • Local Institution - 012-814
    • Gainesville, Virginia, United States, 20155
      • Local Institution - 012-814 - C
    • Leesburg, Virginia, United States, 20176
      • Local Institution - 012-814 - D

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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)	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	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	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		Up to 49 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	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	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	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	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	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	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	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	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	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

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Barlesi F, Yao W, Duruisseaux M, Doucet L, Martinez AA, Gregorc V, Juan-Vidal O, Lu S, De Bondt C, de Marinis F, Linardou H, Kim YC, Jotte R, Felip E, Lo Russo G, Reck M, Michenzie MF, Yang W, Meade JN, Korytowsky B, Mok TSK; KRYSTAL-12 Investigators. Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial. Lancet. 2025 Aug 9;406(10503):615-626. doi: 10.1016/S0140-6736(25)00866-9.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Estimated): October 30, 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): August 11, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Docetaxel; NSCLC; Non-small cell lung cancer; KRAS G12C; Metastatic Cancer; KRAS; Adagrasib; Phase 3 Clinical Trial; KRAZATI
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; adagrasib
• 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)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No