AzTrials
AzTrials

Metastatic Non Small Cell Lung CancerPhase 3KRYSTAL-12NCT04685135

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

A Phase 3 study testing MRTX849 and Docetaxel in people with Metastatic Non Small Cell Lung Cancer and Advanced Non Small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 380 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MRTX849 and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
453 participants
Where
380 sitesin 24 countries
Study dates
23 Feb 2021to 30 Oct 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

380 sites in 24 countries.

380 sites in 24 countries

United States112 sites

  • Local Institution - 012-888

    Arlington, Texas, 76012

  • Local Institution - 012-814 - B

    Arlington, Virginia, 22205

  • Local Institution - 012-941

    Athens, Georgia, 30607

  • Local Institution - 012-835 - A

    Austell, Georgia, 30106

  • Local Institution - 012-892

    Austin, Texas, 78745

  • Local Institution - 012-841 - A

    Billings, Montana, 59101

  • Local Institution - 012-841

    Billings, Montana, 59101

  • Local Institution - 012-846

    Billings, Montana, 59102

  • Local Institution - 012-952

    Bolivar, Missouri, 65613

  • Local Institution - 012-835 - B

    Carrollton, Georgia, 30117

  • Local Institution - 012-835 - C

    Cartersville, Georgia, 30121

  • Local Institution - 012-898

    Cerritos, California, 90703

  • Local Institution - 012-942-B

    Chanute, Kansas, 66720

  • Local Institution - 012-953

    Charlottesville, Virginia, 22908-0674

  • Local Institution - 012-917

    Chicago, Illinois, 60612

  • Local Institution - 012-972

    Chicago, Illinois, 60637

  • Local Institution - 012-849

    Cleveland, Ohio, 44106

  • Local Institution - 012-951-B

    Denver, Colorado, 80218

  • Local Institution - 012-942-C

    Dodge City, Kansas, 67801

  • Local Institution - 012-835 - D

    Douglasville, Georgia, 30134

  • Local Institution - 012-910

    Duarte, California, 91010

  • Local Institution - 012-975

    East Brunswick, New Jersey, 08816

  • Local Institution - 012-975 - A

    Edison, New Jersey, 08820

  • Local Institution - 012-942-D

    El Dorado, Kansas, 67042

  • Local Institution - 012-814 - A

    Fairfax, Virginia, 22031

  • Local Institution - 012-814

    Fairfax, Virginia, 22031

  • Local Institution - 012-562-B

    Fleming Island, Florida, 32003

  • Local Institution - 012-968

    Fort Lauderdale, Florida, 33308

  • Local Institution - 012-856

    Frederick, Maryland, 21702

  • Local Institution - 012-814 - C

    Gainesville, Virginia, 20155

  • Local Institution - 012-898 D

    Glendale, California, 91204

  • Local Institution - 012-943

    Goshen, Indiana, 46526

  • Local Institution - 012-891

    Greenville, South Carolina, 29605

  • Local Institution - 012-972 C

    Harvey, Illinois, 60426

  • Local Institution - 012-910-A

    Huntington Beach, California, 92648

  • Local Institution - 012-942-E

    Independence, Kansas, 67301

  • Local Institution - 012-569

    Indianapolis, Indiana, 46237

  • Local Institution - 012-910-C

    Irvine, California, 92618

  • Local Institution - 012-999

    Irving, Texas, 75063

  • Local Institution - 012-562-D

    Jacksonville, Florida, 32204

  • Local Institution - 012-853

    Jacksonville, Florida, 32204

  • Local Institution - 012-562-E

    Jacksonville, Florida, 32207

  • Local Institution - 012-562-A

    Jacksonville, Florida, 32256

  • Local Institution - 012-562-C

    Jacksonville, Florida, 32256

  • Local Institution - 012-562-F

    Jacksonville, Florida, 32256

  • Local Institution - 012-562-G

    Jacksonville, Florida, 32256

  • Local Institution - 012-562

    Jacksonville, Florida, 32256

  • Local Institution - 012-954 - A

    Kennebunk, Maine, 04043

  • Local Institution - 012-836

    Kettering, Ohio, 45429

  • Local Institution - 012-942-F

    Kingman, Kansas, 67068

  • Local Institution - 012-951

    Lafayette, Colorado, 80026

  • Local Institution - 012-569 - B

    Lafayette, Indiana, 47905

  • Local Institution - 012-569 - C

    Lafayette, Indiana, 47905

  • Local Institution - 012-814 - D

    Leesburg, Virginia, 20176

  • Local Institution - 012-965

    Lexington, Kentucky, 40503

  • Local Institution - 012-942-G

    Liberal, Kansas, 67901

  • Local Institution - 012-872

    Lone Tree, Colorado, 80124

  • Local Institution - 012-910-B

    Long Beach, California, 90808

  • Local Institution - 012-910-F

    Long Beach, California, 90813

  • Local Institution - 012-835

    Marietta, Georgia, 30060

  • Local Institution - 012-942-H

    McPherson, Kansas, 67460

  • Local Institution - 012-825

    Miami Beach, Florida, 33140

  • Local Institution - 012-975 - B

    Monroe, New Jersey, 08831

  • Local Institution - 012-569 - A

    Mooresville, Indiana, 46158

  • Local Institution - 012-782

    Munster, Indiana, 46321

  • Local Institution - 012-972 A

    New Lenox, Illinois, 60451

  • Local Institution - 012-911 A

    New Orleans, Louisiana, 70112

  • Local Institution - 012-911

    New Orleans, Louisiana, 70112

  • Local Institution - 012-910-D

    Newport Beach, California, 92663

  • Local Institution - 012-942-I

    Newton, Kansas, 67114

  • Local Institution - 012-883

    Niles, Illinois, 60714

  • Local Institution - 012-974-B

    Novi, Michigan, 48374

  • Local Institution - 012-974-C

    Novi, Michigan, 48374

  • Local Institution - 012-972 B

    Orland Park, Illinois, 60462

  • Local Institution - 012-973

    Orlando, Florida, 32806

  • Local Institution - 012-942-J

    Parsons, Kansas, 67357

  • Local Institution - 012-877

    Pensacola, Florida, 32503

  • Local Institution - 012-839

    Plantation, Florida, 33322

  • Local Institution - 012-942-K

    Pratt, Kansas, 67124

  • Local Institution - 012-960

    Providence, Rhode Island, 02903

  • Local Institution - 012-960-A

    Providence, Rhode Island, 02906

  • Local Institution - 012-967

    Salem, Oregon, 97301

  • Local Institution - 012-942-L

    Salina, Kansas, 67401

  • Local Institution - 012-976

    Salt Lake City, Utah, 84106

  • Local Institution - 012-976-A

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-B

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-C

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-D

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-E

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-F

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-G

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-H

    Salt Lake City, Utah, 84124

  • Local Institution - 012-976-I

    Salt Lake City, Utah, 84124

  • Local Institution - 012-898 C

    Santa Ana, California, 92705

  • Local Institution - 012-858

    Santa Rosa, California, 95403

  • Local Institution - 012-954

    Scarborough, Maine, 04074

  • Local Institution - 012-890

    Sherman, Texas, 75090

  • Local Institution - 012-940

    Sioux Falls, South Dakota, 57105

  • Local Institution - 012-975 - C

    Somerset, New Jersey, 08873

  • Local Institution - 012-975 - D

    Somerville, New Jersey, 08876

  • Local Institution - 012-974-A

    Southfield, Michigan, 48075

  • Local Institution - 012-974

    Southfield, Michigan, 48075

  • Local Institution - 012-962

    Syracuse, New York, 13210-2306

  • Local Institution - 012-577

    Teaneck, New Jersey, 07666

  • Local Institution - 012-954 - B

    Topsham, Maine, 04086

  • Local Institution - 012-910-E

    Torrance, California, 90505

  • Local Institution - 012-942-M

    Wellington, Kansas, 67152

  • Local Institution - 012-820

    Westwood, Kansas, 66205

  • Local Institution - 012-951-A

    Wheat Ridge, Colorado, 80033-6005

  • Local Institution - 012-942-A

    Wichita, Kansas, 67208

  • Local Institution - 012-942

    Wichita, Kansas, 67214

  • Local Institution - 012-942-N

    Winfield, Kansas, 67156

Other trials in United States

China37 sites

  • Local Institution - 012-725

    Beijing, Beijing Municipality, 100039

  • Local Institution - 012-700

    Beijing, Beijing Municipality, 100142

  • Local Institution - 012-738

    Beijing, Beijing Municipality, 100142

  • Local Institution - 012-724

    Beijing, Beijing Municipality, 100730

  • Local Institution - 012-030

    Changchun, Jilin, 130012

  • Local Institution - 012-702

    Changsha, Hunan, 410006

  • Local Institution - 012-710

    Chengdu, Sichuan, 610041

  • Local Institution - 012-721

    Chengdu, Sichuan, 610041

  • Local Institution - 012-727

    Chongqing, Chongqing Municipality, 400038

  • Local Institution - 012-726

    Chongqing, Chongqing Municipality, 400042

  • Local Institution - 012-029

    Fuzhou, Fujian, 350014

  • Local Institution - 012-712

    Guangzhou, Guangdong, 510120

  • Local Institution - 012-739

    Guangzhou, Guangdong, 510515

  • Local Institution - 012-722

    Hangzhou, Zhejiang, 310003

  • Local Institution - 012-736

    Hangzhou, Zhejiang, 310016

  • Local Institution - 012-034

    Hangzhou, Zhejiang, 310022

  • Local Institution - 012-028

    Harbin, Heilongjiang, 150081

  • Local Institution - 012-036

    Jinan, Shandong, 250117

  • Local Institution - 012-737

    Linyi, Shandong, 276001

  • Local Institution - 012-733

    Liuzhou, Guangxi, 545006

  • Local Institution - 012-706

    Nanchang, Jiangxi, 330006

  • Local Institution - 012-731

    Nanchang, Jiangxi, 330006

  • Local Institution - 012-735

    Nanjing, Jiangsu, 210006

  • Local Institution - 012-734

    Nanjing, Jiangsu, 210008

  • Local Institution - 012-729

    Nanjing, Jiangsu, 210029

  • Local Institution - 012-741

    Qingdao, Shandong, 266555

  • Local Institution - 012-719

    Shanghai, Shanghai Municipality, 200030

  • Local Institution - 012-024

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 012-025

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 012-709

    Shenyang, Liaoning, 110001

  • Local Institution - 012-023

    Wuhan, Hubei, 430022

  • Local Institution - 012-701

    Wuhan, Hubei, 430079

  • Local Institution - 012-732

    Xiamen, Fujian, 361003

  • Local Institution - 012-740

    Xinxiang, Henan, 453100

  • Local Institution - 012-728

    Xuzhou, Jiangsu, 221009

  • Local Institution - 012-021

    Zhengzhou, Henan, 450008

  • Local Institution - 012-730

    Zhengzhou, Henan, 450052

Other trials in China

Spain29 sites

  • Local Institution - 012-613

    A Coruña, 15006

  • Local Institution - 012-769

    Alicante, 3010

  • Local Institution - 012-610

    Badalona, 08916

  • Local Institution - 012-776

    Barakaldo, 48903

  • Local Institution - 012-761

    Barcelona, 08003

  • Local Institution - 012-614

    Barcelona, 08028

  • Local Institution - 012-612

    Barcelona, 08035

  • Local Institution - 012-600

    Barcelona, 08036

  • Local Institution - 012-621

    Córdoba, 14004

  • Local Institution - 012-764

    Girona, 17007

  • Local Institution - 012-616

    Granada, 18014

  • Local Institution - 012-628

    Las Palmas de Gran Canaria, 35016

  • Local Institution - 012-775

    León, 24071

  • Local Institution - 012-615

    Lugo, 27003

  • Local Institution - 012-607

    Madrid, 28007

  • Local Institution - 012-611

    Madrid, 28027

  • Local Institution - 012-606

    Madrid, 28034

  • Local Institution - 012-601

    Madrid, 28040

  • Local Institution - 012-609

    Madrid, 28040

  • Local Institution - 012-617

    Madrid, 28041

  • Local Institution - 012-626

    Majadahonda, 28222

  • Local Institution - 012-608

    Málaga, 29009

  • Local Institution - 012-602

    Palma de Mallorca, 07120

  • Local Institution - 012-611A

    Pamplona, Navarre, 31008

  • Local Institution - 012-604

    Santander, 39008

  • Local Institution - 012-629

    Seville, 41013

  • Local Institution - 012-625

    Valencia, 46014

  • Local Institution - 012-605

    Valencia, 46026

  • Local Institution - 012-603

    Zaragoza, 50009

Other trials in Spain

Italy25 sites

  • Local Institution - 012-276

    Alessandria, 15121

  • Local Institution - 012-292

    Avellino, 83100

  • Local Institution - 012-274

    Aviano, 33081

  • Local Institution - 012-275

    Bari, 70124

  • Local Institution - 012-765

    Brescia, 25123

  • Local Institution - 012-286

    Candiolo, 10060

  • Local Institution - 012-284

    Catania, 95122

  • Local Institution - 012-282

    Catania, 95123

  • Local Institution - 012-762

    Florence, 50134

  • Local Institution - 012-273

    Genova, 16100

  • Local Institution - 012-285

    Genova, 16132

  • Local Institution - 012-279

    Lecce, 73100

  • Local Institution - 012-270

    Meldola, 47014

  • Local Institution - 012-296

    Milan, 20132

  • Local Institution - 012-278

    Milan, 20141

  • Local Institution - 012-283

    Milan, 20133

  • Local Institution - 012-271

    Naples, 80131

  • Local Institution - 012-277

    Naples, 80131

  • Local Institution - 012-770

    Novara, 28100

  • Local Institution - 012-272

    Parma, 43126

  • Local Institution - 012-281

    Perugia, 06132

  • Local Institution - 012-766

    Pesaro, 61122

  • Local Institution - 012-767

    Ravenna, 48121

  • Local Institution - 012-295

    Roma, 00144

  • Local Institution - 012-758

    Verona, 37126

Other trials in Italy

France23 sites

  • Local Institution - 012-194

    Brest, 29200

  • Local Institution - 012-191

    Bron, 69500

  • Local Institution - 012-193

    Caen, 14033

  • Local Institution - 012-196

    Caen, 14076

  • Local Institution - 012-190

    Créteil, 94000

  • Local Institution - 012-192

    Dijon, 21079

  • Local Institution - 012-201

    Gleizé, 69400

  • Local Institution - 012-683

    La Tronche, 38700

  • Local Institution - 012-665

    Lille, 59037

  • Local Institution - 012-195

    Limoges, 87042

  • Local Institution - 012-191-B

    Lyon, Rhone, 69004

  • Local Institution - 012-199

    Marseille, 13009

  • Local Institution - 012-687

    Marseille, 13015

  • Local Institution - 012-200

    Montpellier, 34090

  • Local Institution - 012-666

    Mulhouse, 68100

  • Local Institution - 012-685

    Nice, 06189

  • Local Institution - 012-191-A

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Local Institution - 012-681

    Quimper, 29107

  • Local Institution - 012-198

    Saint-Herblain, 44805

  • Local Institution - 012-684

    Strasbourg, 67091

  • Local Institution - 012-197

    Strasbourg, 67200

  • Local Institution - 012-209

    Tours, 37044

  • Local Institution - 012-202

    Villejuif, 94805

Other trials in France

South Korea18 sites

  • Local Institution - 012-111

    Busan, 48108

  • Local Institution - 012-522

    Busan, 49241

  • Local Institution - 012-101

    Busan, 602702

  • Local Institution - 012-113

    Cheongju-si, 28644

  • Local Institution - 012-110

    Daegu, 41404

  • Local Institution - 012-523

    Daegu, 42601

  • Local Institution - 012-100

    Hwasun-gun, 58128

  • Local Institution - 012-103

    Incheon, 21565

  • Local Institution - 012-102

    Junggu, 400-712

  • Local Institution - 012-520

    Seongnam-si, 13496

  • Local Institution - 012-112

    Seongnam-si, 13620

  • Local Institution - 012-105

    Seoul, 02841

  • Local Institution - 012-118

    Seoul, 03722

  • Local Institution - 012-106

    Seoul, 05080

  • Local Institution - 012-104

    Seoul, 05505

  • Local Institution - 012-109

    Seoul, 06591

  • Local Institution - 012-521

    Suwon, 16247

  • Local Institution - 012-107

    Suwon, 16499

Other trials in South Korea

Portugal16 sites

  • Local Institution - 012-644

    Almada, 2805-267

  • Local Institution - 012-332

    Braga, 4710-243

  • Local Institution - 012-330

    Coimbra, 3000-075

  • Local Institution - 012-645

    Coimbra, 3000-075

  • Local Institution - 012-333

    Guimarães, 4835-044

  • Local Institution - 012-642

    Lisbon, 1099-023

  • Local Institution - 012-338-A

    Lisbon, 1350-352

  • Local Institution - 012-337

    Lisbon, 1400-038

  • Local Institution - 012-338

    Lisbon, 1998-018

  • Local Institution - 012-647

    Loures, 2674-514

  • Local Institution - 012-334

    Porto, 14341

  • Local Institution - 012-331

    Porto, 4099-001

  • Local Institution - 012-339

    Porto, 4200-072

  • Local Institution - 012-641

    Santa Maria da Feira, 4520-211

  • Local Institution - 012-646

    Setúbal, 2910-443

  • Local Institution - 012-335

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Germany15 sites

  • Local Institution - 012-219

    Bad Berka, 99437

  • Local Institution - 012-222

    Bonn, 53127

  • Local Institution - 012-221

    Cologne, 51109

  • Local Institution - 012-210

    Essen, 45136

  • Local Institution - 012-214

    Gauting, 82131

  • Local Institution - 012-671

    Giessen, 35392

  • Local Institution - 012-659

    Grohansdorf, 22927

  • Local Institution - 012-215

    Halle, 06120

  • Local Institution - 012-225

    Jena, 07747

  • Local Institution - 012-213

    Kassel, 34125

  • Local Institution - 012-224

    Löwenstein, 74245

  • Local Institution - 012-216

    Lübeck, 23538

  • Local Institution - 012-220

    München, 81925

  • Local Institution - 012-672

    Offenbach, 63069

  • Local Institution - 012-212

    Oldenburg, 26121

Other trials in Germany

Romania12 sites

  • Local Institution - 012-347

    Baia Mare, 430031

  • Local Institution - 012-349

    Brasov, 500152

  • Local Institution - 012-341

    Bucharest, 010991

  • Local Institution - 012-342

    Bucharest, 022328

  • Local Institution - 012-344

    Cluj-Napoca, 400015

  • Local Institution - 012-340

    Cluj-Napoca, 400641

  • Local Institution - 012-514

    Craiova, 200385

  • Local Institution - 012-343

    Craiova, 200746

  • Local Institution - 012-513

    Iași, 700106

  • Local Institution - 012-519

    Ovidiu, 905900

  • Local Institution - 012-515

    Timișoara, 300166

  • Local Institution - 012-345

    Timișoara, 300239

Other trials in Romania

Greece11 sites

  • Local Institution - 012-502

    Athens, Attica, 11526

  • Local Institution - 012-236

    Athens, 11527

  • University General Hospital of Heraklion (PAGNI)

    Heraklion, 71110

  • Local Institution - 012-235

    Larissa, 41110

  • Local Institution - 012-237

    Nea Kifissia, 145 64

  • Local Institution - 012-234

    Piraeus, 185 47

  • Local Institution - 012-239

    Piraeus, 185 47

  • Local Institution - 012-504

    Thessaloniki, 54622

  • Local Institution - 012-230

    Thessaloniki, 57001

  • Local Institution - 012-500

    Thessaloniki, 57010

  • Local Institution - 012-503

    Volos, 38333

Other trials in Greece

Russia11 sites

  • Local Institution - 012-352

    Chelyabinsk, 454048

  • Local Institution - 012-351

    Izhevsk, 426067

  • Local Institution - 012-362

    Kislino Village, 305524

  • Local Institution - 012-353

    Moscow, 121309

  • Local Institution - 012-368

    Moscow, 121467

  • Local Institution - 012-359

    Nizhny Novgorod, 603006

  • Local Institution - 012-356

    Novosibirsk, 630099

  • Local Institution - 012-350

    Omsk, 644013

  • Local Institution - 012-355

    Saint Petersburg, 197022

  • Local Institution - 012-358

    Saint Petersburg, 197376

  • Local Institution - 012-354

    Saint Petersburg, 197758

Other trials in Russia

Poland9 sites

  • Local Institution - 012-757

    Lodz, 90-302

  • Local Institution - 012-321

    Lublin, 20-064

  • Local Institution - 012-760

    Lublin, 20-093

  • Local Institution - 012-325

    Otwock, 05-400

  • Local Institution - 012-320

    Rzeszów, 35-922

  • Local Institution - 012-324

    Skorzewo, 60-185

  • Local Institution - 012-329

    Torun, 87-100

  • Local Institution - 012-322

    Warsaw, 02-781

  • Local Institution - 012-774

    Warsaw, 04-349

Other trials in Poland

Australia8 sites

  • Local Institution - 012-005

    Bedford Park, 5042

  • Local Institution - 012-004

    Clayton, 3168

  • Local Institution - 012-014

    Douglas, 4814

  • Local Institution - 012-016

    Mackay, Queensland, 4740

  • Local Institution - 012-013

    St Leonards, 2065

  • Local Institution - 012-019

    Tweed Heads, 2485

  • Local Institution - 012-017

    Wollongong, 2500

  • Local Institution - 012-009

    Woolloongabba, 4102

Other trials in Australia

Belgium8 sites

  • Local Institution - 012-154

    Brussels, 1090

  • Local Institution - 012-157

    Edegem, 2650

  • Local Institution - 012-155

    Ghent, 9000

  • Local Institution - 012-151

    Gilly, 6060

  • Local Institution - 012-158

    Hasselt, 3500

  • Local Institution - 012-152

    Roeselare, 8800

  • Local Institution - 012-153

    Ronse, 9600

  • Local Institution - 012-150

    Yvoir, B-5530

Other trials in Belgium

Hungary7 sites

  • Local Institution - 012-242

    Budapest, 1083

  • Local Institution - 012-244

    Budapest, 1121

  • Local Institution - 012-241

    Budapest, 1122

  • Local Institution - 012-243

    Gyöngyös, 3200

  • Local Institution - 012-763

    Gyula, 5700

  • Local Institution - 012-759

    Székesfehérvár, 8000

  • Local Institution - 012-240

    Törökbálint, 2045

Other trials in Hungary

Netherlands7 sites

  • Local Institution - 012-306

    Amsterdam, 1081 HV

  • Local Institution - 012-309

    Breda, 4818 CK

  • Local Institution - 012-300

    Maastricht, 6229 HX

  • Local Institution - 012-630

    Nijmegen, 6525 GA

  • Local Institution - 012-308

    The Hague, 2545 AA

  • Local Institution - 012-307

    Utrecht, 3543 AZ

  • Local Institution - 012-631

    Utrecht, 3584 CX

Other trials in Netherlands

Ireland6 sites

  • Local Institution - 012-250

    Dublin, 4

  • Local Institution - 012-252

    Dublin, 9

  • Local Institution - 012-259

    Dublin, D08 NHY1

  • Local Institution - 012-257

    Galway, H91 YR71

  • Local Institution - 012-258

    Limerick, V94 F858

  • Local Institution - 012-255

    Tallaght, Dublin, D24 NR04

Other trials in Ireland

Singapore5 sites

  • Local Institution - 012-093

    Singapore, 168583

  • Local Institution - 012-095

    Singapore, 188770

  • Local Institution - 012-092

    Singapore, 217562

  • Local Institution - 012-091

    Singapore, 258499

  • Local Institution - 012-094

    Singapore, 258500

Other trials in Singapore

United Kingdom5 sites

  • Local Institution - 012-401

    Birmingham, B9 5SS

  • Local Institution - 012-415

    Edinburgh, EH4 2XU

  • Local Institution - 012-400

    Glasgow, G12 0XH

  • Local Institution - 012-408

    Leicester, LE1 5WW

  • Local Institution - 012-407

    Manchester, M20 4BX

Other trials in United Kingdom

Czechia4 sites

  • Local Institution - 012-164

    Hořovice, 268 31

  • Local Institution - 012-162

    Olomouc, 779 00

  • Local Institution - 012-163

    Prague, 128 08

  • Local Institution - 012-168

    Praha 8 - Liben, 180 81

Other trials in Czechia

Austria3 sites

  • Local Institution - 012-142

    Klagenfurt, 9020

  • Local Institution - 012-140

    Salzburg, 5020

  • Local Institution - 012-146

    Vienna, 1160

Other trials in Austria

Hong Kong3 sites

  • Local Institution - 012-048

    Central, 0

  • Local Institution - 012-043

    Hong Kong, 0

  • Local Institution - 012-040

    Kowloon, 0

Other trials in Hong Kong

Puerto Rico3 sites

  • Local Institution - 012-903

    San Juan, PR, 00927

  • Local Institution - 012-900

    San Juan, PR, 00935

  • Local Institution - 012-901

    San Juan, 00919

Other trials in Puerto Rico

Switzerland3 sites

  • Local Institution - 012-390

    Basel, 4031

  • Local Institution - 012-391

    Thun, 3604

  • Local Institution - 012-392

    Winterthur, 8401

Other trials in Switzerland

About this study

Official title: 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.

Being tested
MRTX849, Docetaxel
Keywords
KRAS G12C, Non-small cell lung cancer, NSCLC, Metastatic Cancer, Docetaxel, Phase 3 Clinical Trial, Adagrasib, KRAS, KRAZATI
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRTX849Drug

    Also called adagrasib, KRAZATI

    21 day cycles

  • DocetaxelDrug

    Also called Taxotere

    21 day cycles

Study groups in NCT04685135
Study groupRoleWhat they receive
MRTX849ExperimentalNot described
Receives: Drug: MRTX849
DocetaxelActive comparatorNot described
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)

Secondary outcomes (13)

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to the date of death due to any cause.

    Measured: From randomization till death due to any cause (up to approximately 143 weeks)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 1-Year Survival Rate

    Measured: Up to 49 months

  5. 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.

    Measured: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)

  6. 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.

    Measured: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)

  7. 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.

    Measured: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

  10. 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.

    Measured: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

  11. 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.

    Measured: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

  12. 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.

    Measured: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

  13. 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.

    Measured: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start23 Feb 2021
  3. Primary completion30 Dec 2023
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685135
Sponsor's protocol ID
CA239-0013
Other IDs
CA239-0013, 849-012
Acronym
KRYSTAL-12
Status last verified
Jul 2026
First submitted
21 Dec 2020
Last updated
11 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • Barlesi F, Yao W, Duruisseaux M, Doucet L, Azkarate Martinez A, 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. Plain language summary of the KRYSTAL-12 study results: adagrasib for non-small cell lung cancer with KRASG12C mutations. Future Oncol. 2026 Sep 16:1-12. doi: 10.1080/14796694.2026.2719409. Online ahead of print.

    PubMed 42745627

  • 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.

    PubMed 40783289

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MRTX849 and Docetaxel in people with Metastatic Non Small Cell Lung Cancer and Advanced Non Small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 380 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 380 sites in United States, China, Spain, Italy, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685135, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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