NCT04685135

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
453

participants targeted

Target at P50-P75 for phase_3

Timeline
1mo left

Started Feb 2021

Longer than P75 for phase_3

Geographic Reach
23 countries

377 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2021Oct 2026

First Submitted

Initial submission to the registry

December 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 22, 2025

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

August 11, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

December 21, 2020

Results QC Date

December 20, 2024

Last Update Submit

July 17, 2026

Conditions

Keywords

KRAS G12CNon-small cell lung cancerNSCLCMetastatic CancerDocetaxelPhase 3 Clinical TrialAdagrasibKRASKRAZATI

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (13)

  • Overall Survival (OS)

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

  • Objective Response Rate (ORR) as Per Blinded Independent Central Review

    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

    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)

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

  • +8 more secondary outcomes

Study Arms (2)

MRTX849

EXPERIMENTAL
Drug: MRTX849

Docetaxel

ACTIVE COMPARATOR
Drug: Docetaxel

Interventions

21 day cycles

Also known as: adagrasib, KRAZATI
MRTX849

21 day cycles

Also known as: Taxotere
Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
  • Candidacy to receive treatment with docetaxel.
  • Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
  • ECOG performance status 0-2

You may not qualify if:

  • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
  • Active brain metastases.
  • Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (380)

Local Institution - 012-898

Cerritos, California, 90703, United States

Location

Local Institution - 012-910

Duarte, California, 91010, United States

Location

Local Institution - 012-898 D

Glendale, California, 91204, United States

Location

Local Institution - 012-910-A

Huntington Beach, California, 92648, United States

Location

Local Institution - 012-910-C

Irvine, California, 92618, United States

Location

Local Institution - 012-910-B

Long Beach, California, 90808, United States

Location

Local Institution - 012-910-F

Long Beach, California, 90813, United States

Location

Local Institution - 012-910-D

Newport Beach, California, 92663, United States

Location

Local Institution - 012-898 C

Santa Ana, California, 92705, United States

Location

Local Institution - 012-858

Santa Rosa, California, 95403, United States

Location

Local Institution - 012-910-E

Torrance, California, 90505, United States

Location

Local Institution - 012-951-B

Denver, Colorado, 80218, United States

Location

Local Institution - 012-951

Lafayette, Colorado, 80026, United States

Location

Local Institution - 012-872

Lone Tree, Colorado, 80124, United States

Location

Local Institution - 012-951-A

Wheat Ridge, Colorado, 80033-6005, United States

Location

Local Institution - 012-562-B

Fleming Island, Florida, 32003, United States

Location

Local Institution - 012-968

Fort Lauderdale, Florida, 33308, United States

Location

Local Institution - 012-562-D

Jacksonville, Florida, 32204, United States

Location

Local Institution - 012-853

Jacksonville, Florida, 32204, United States

Location

Local Institution - 012-562-E

Jacksonville, Florida, 32207, United States

Location

Local Institution - 012-562-A

Jacksonville, Florida, 32256, United States

Location

Local Institution - 012-562-C

Jacksonville, Florida, 32256, United States

Location

Local Institution - 012-562-F

Jacksonville, Florida, 32256, United States

Location

Local Institution - 012-562-G

Jacksonville, Florida, 32256, United States

Location

Local Institution - 012-562

Jacksonville, Florida, 32256, United States

Location

Local Institution - 012-825

Miami Beach, Florida, 33140, United States

Location

Local Institution - 012-973

Orlando, Florida, 32806, United States

Location

Local Institution - 012-877

Pensacola, Florida, 32503, United States

Location

Local Institution - 012-839

Plantation, Florida, 33322, United States

Location

Local Institution - 012-941

Athens, Georgia, 30607, United States

Location

Local Institution - 012-835 - A

Austell, Georgia, 30106, United States

Location

Local Institution - 012-835 - B

Carrollton, Georgia, 30117, United States

Location

Local Institution - 012-835 - C

Cartersville, Georgia, 30121, United States

Location

Local Institution - 012-835 - D

Douglasville, Georgia, 30134, United States

Location

Local Institution - 012-835

Marietta, Georgia, 30060, United States

Location

Local Institution - 012-917

Chicago, Illinois, 60612, United States

Location

Local Institution - 012-972

Chicago, Illinois, 60637, United States

Location

Local Institution - 012-972 C

Harvey, Illinois, 60426, United States

Location

Local Institution - 012-972 A

New Lenox, Illinois, 60451, United States

Location

Local Institution - 012-883

Niles, Illinois, 60714, United States

Location

Local Institution - 012-972 B

Orland Park, Illinois, 60462, United States

Location

Local Institution - 012-943

Goshen, Indiana, 46526, United States

Location

Local Institution - 012-569

Indianapolis, Indiana, 46237, United States

Location

Local Institution - 012-569 - B

Lafayette, Indiana, 47905, United States

Location

Local Institution - 012-569 - C

Lafayette, Indiana, 47905, United States

Location

Local Institution - 012-569 - A

Mooresville, Indiana, 46158, United States

Location

Local Institution - 012-782

Munster, Indiana, 46321, United States

Location

Local Institution - 012-942-B

Chanute, Kansas, 66720, United States

Location

Local Institution - 012-942-C

Dodge City, Kansas, 67801, United States

Location

Local Institution - 012-942-D

El Dorado, Kansas, 67042, United States

Location

Local Institution - 012-942-E

Independence, Kansas, 67301, United States

Location

Local Institution - 012-942-F

Kingman, Kansas, 67068, United States

Location

Local Institution - 012-942-G

Liberal, Kansas, 67901, United States

Location

Local Institution - 012-942-H

McPherson, Kansas, 67460, United States

Location

Local Institution - 012-942-I

Newton, Kansas, 67114, United States

Location

Local Institution - 012-942-J

Parsons, Kansas, 67357, United States

Location

Local Institution - 012-942-K

Pratt, Kansas, 67124, United States

Location

Local Institution - 012-942-L

Salina, Kansas, 67401, United States

Location

Local Institution - 012-942-M

Wellington, Kansas, 67152, United States

Location

Local Institution - 012-820

Westwood, Kansas, 66205, United States

Location

Local Institution - 012-942-A

Wichita, Kansas, 67208, United States

Location

Local Institution - 012-942

Wichita, Kansas, 67214, United States

Location

Local Institution - 012-942-N

Winfield, Kansas, 67156, United States

Location

Local Institution - 012-965

Lexington, Kentucky, 40503, United States

Location

Local Institution - 012-911 A

New Orleans, Louisiana, 70112, United States

Location

Local Institution - 012-911

New Orleans, Louisiana, 70112, United States

Location

Local Institution - 012-954 - A

Kennebunk, Maine, 04043, United States

Location

Local Institution - 012-954

Scarborough, Maine, 04074, United States

Location

Local Institution - 012-954 - B

Topsham, Maine, 04086, United States

Location

Local Institution - 012-856

Frederick, Maryland, 21702, United States

Location

Local Institution - 012-974-B

Novi, Michigan, 48374, United States

Location

Local Institution - 012-974-C

Novi, Michigan, 48374, United States

Location

Local Institution - 012-974-A

Southfield, Michigan, 48075, United States

Location

Local Institution - 012-974

Southfield, Michigan, 48075, United States

Location

Local Institution - 012-952

Bolivar, Missouri, 65613, United States

Location

Local Institution - 012-841 - A

Billings, Montana, 59101, United States

Location

Local Institution - 012-841

Billings, Montana, 59101, United States

Location

Local Institution - 012-846

Billings, Montana, 59102, United States

Location

Local Institution - 012-975

East Brunswick, New Jersey, 08816, United States

Location

Local Institution - 012-975 - A

Edison, New Jersey, 08820, United States

Location

Local Institution - 012-975 - B

Monroe, New Jersey, 08831, United States

Location

Local Institution - 012-975 - C

Somerset, New Jersey, 08873, United States

Location

Local Institution - 012-975 - D

Somerville, New Jersey, 08876, United States

Location

Local Institution - 012-577

Teaneck, New Jersey, 07666, United States

Location

Local Institution - 012-962

Syracuse, New York, 13210-2306, United States

Location

Local Institution - 012-849

Cleveland, Ohio, 44106, United States

Location

Local Institution - 012-836

Kettering, Ohio, 45429, United States

Location

Local Institution - 012-967

Salem, Oregon, 97301, United States

Location

Local Institution - 012-960

Providence, Rhode Island, 02903, United States

Location

Local Institution - 012-960-A

Providence, Rhode Island, 02906, United States

Location

Local Institution - 012-891

Greenville, South Carolina, 29605, United States

Location

Local Institution - 012-940

Sioux Falls, South Dakota, 57105, United States

Location

Local Institution - 012-888

Arlington, Texas, 76012, United States

Location

Local Institution - 012-892

Austin, Texas, 78745, United States

Location

Local Institution - 012-999

Irving, Texas, 75063, United States

Location

Local Institution - 012-890

Sherman, Texas, 75090, United States

Location

Local Institution - 012-976

Salt Lake City, Utah, 84106, United States

Location

Local Institution - 012-976-A

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-B

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-C

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-D

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-E

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-F

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-G

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-H

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-976-I

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 012-814 - B

Arlington, Virginia, 22205, United States

Location

Local Institution - 012-953

Charlottesville, Virginia, 22908-0674, United States

Location

Local Institution - 012-814 - A

Fairfax, Virginia, 22031, United States

Location

Local Institution - 012-814

Fairfax, Virginia, 22031, United States

Location

Local Institution - 012-814 - C

Gainesville, Virginia, 20155, United States

Location

Local Institution - 012-814 - D

Leesburg, Virginia, 20176, United States

Location

Local Institution - 012-016

Mackay, Queensland, 4740, Australia

Location

Local Institution - 012-005

Bedford Park, 5042, Australia

Location

Local Institution - 012-004

Clayton, 3168, Australia

Location

Local Institution - 012-014

Douglas, 4814, Australia

Location

Local Institution - 012-013

St Leonards, 2065, Australia

Location

Local Institution - 012-019

Tweed Heads, 2485, Australia

Location

Local Institution - 012-017

Wollongong, 2500, Australia

Location

Local Institution - 012-009

Woolloongabba, 4102, Australia

Location

Local Institution - 012-142

Klagenfurt, 9020, Austria

Location

Local Institution - 012-140

Salzburg, 5020, Austria

Location

Local Institution - 012-146

Vienna, 1160, Austria

Location

Local Institution - 012-154

Brussels, 1090, Belgium

Location

Local Institution - 012-157

Edegem, 2650, Belgium

Location

Local Institution - 012-155

Ghent, 9000, Belgium

Location

Local Institution - 012-151

Gilly, 6060, Belgium

Location

Local Institution - 012-158

Hasselt, 3500, Belgium

Location

Local Institution - 012-152

Roeselare, 8800, Belgium

Location

Local Institution - 012-153

Ronse, 9600, Belgium

Location

Local Institution - 012-150

Yvoir, B-5530, Belgium

Location

Local Institution - 012-725

Beijing, Beijing Municipality, 100039, China

Location

Local Institution - 012-700

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 012-738

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 012-724

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 012-727

Chongqing, Chongqing Municipality, 400038, China

Location

Local Institution - 012-726

Chongqing, Chongqing Municipality, 400042, China

Location

Local Institution - 012-029

Fuzhou, Fujian, 350014, China

Location

Local Institution - 012-732

Xiamen, Fujian, 361003, China

Location

Local Institution - 012-712

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 012-739

Guangzhou, Guangdong, 510515, China

Location

Local Institution - 012-733

Liuzhou, Guangxi, 545006, China

Location

Local Institution - 012-028

Harbin, Heilongjiang, 150081, China

Location

Local Institution - 012-740

Xinxiang, Henan, 453100, China

Location

Local Institution - 012-021

Zhengzhou, Henan, 450008, China

Location

Local Institution - 012-730

Zhengzhou, Henan, 450052, China

Location

Local Institution - 012-023

Wuhan, Hubei, 430022, China

Location

Local Institution - 012-701

Wuhan, Hubei, 430079, China

Location

Local Institution - 012-702

Changsha, Hunan, 410006, China

Location

Local Institution - 012-735

Nanjing, Jiangsu, 210006, China

Location

Local Institution - 012-734

Nanjing, Jiangsu, 210008, China

Location

Local Institution - 012-729

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 012-728

Xuzhou, Jiangsu, 221009, China

Location

Local Institution - 012-706

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 012-731

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 012-030

Changchun, Jilin, 130012, China

Location

Local Institution - 012-709

Shenyang, Liaoning, 110001, China

Location

Local Institution - 012-036

Jinan, Shandong, 250117, China

Location

Local Institution - 012-737

Linyi, Shandong, 276001, China

Location

Local Institution - 012-741

Qingdao, Shandong, 266555, China

Location

Local Institution - 012-719

Shanghai, Shanghai Municipality, 200030, China

Location

Local Institution - 012-024

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 012-025

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 012-710

Chengdu, Sichuan, 610041, China

Location

Local Institution - 012-721

Chengdu, Sichuan, 610041, China

Location

Local Institution - 012-722

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 012-736

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 012-034

Hangzhou, Zhejiang, 310022, China

Location

Local Institution - 012-164

Hořovice, 268 31, Czechia

Location

Local Institution - 012-162

Olomouc, 779 00, Czechia

Location

Local Institution - 012-163

Prague, 128 08, Czechia

Location

Local Institution - 012-168

Praha 8 - Liben, 180 81, Czechia

Location

Local Institution - 012-191-A

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

Location

Local Institution - 012-191-B

Lyon, Rhone, 69004, France

Location

Local Institution - 012-194

Brest, 29200, France

Location

Local Institution - 012-191

Bron, 69500, France

Location

Local Institution - 012-193

Caen, 14033, France

Location

Local Institution - 012-196

Caen, 14076, France

Location

Local Institution - 012-190

Créteil, 94000, France

Location

Local Institution - 012-192

Dijon, 21079, France

Location

Local Institution - 012-201

Gleizé, 69400, France

Location

Local Institution - 012-683

La Tronche, 38700, France

Location

Local Institution - 012-665

Lille, 59037, France

Location

Local Institution - 012-195

Limoges, 87042, France

Location

Local Institution - 012-199

Marseille, 13009, France

Location

Local Institution - 012-687

Marseille, 13015, France

Location

Local Institution - 012-200

Montpellier, 34090, France

Location

Local Institution - 012-666

Mulhouse, 68100, France

Location

Local Institution - 012-685

Nice, 06189, France

Location

Local Institution - 012-681

Quimper, 29107, France

Location

Local Institution - 012-198

Saint-Herblain, 44805, France

Location

Local Institution - 012-684

Strasbourg, 67091, France

Location

Local Institution - 012-197

Strasbourg, 67200, France

Location

Local Institution - 012-209

Tours, 37044, France

Location

Local Institution - 012-202

Villejuif, 94805, France

Location

Local Institution - 012-219

Bad Berka, 99437, Germany

Location

Local Institution - 012-222

Bonn, 53127, Germany

Location

Local Institution - 012-221

Cologne, 51109, Germany

Location

Local Institution - 012-210

Essen, 45136, Germany

Location

Local Institution - 012-214

Gauting, 82131, Germany

Location

Local Institution - 012-671

Giessen, 35392, Germany

Location

Local Institution - 012-659

Grohansdorf, 22927, Germany

Location

Local Institution - 012-215

Halle, 06120, Germany

Location

Local Institution - 012-225

Jena, 07747, Germany

Location

Local Institution - 012-213

Kassel, 34125, Germany

Location

Local Institution - 012-224

Löwenstein, 74245, Germany

Location

Local Institution - 012-216

Lübeck, 23538, Germany

Location

Local Institution - 012-220

München, 81925, Germany

Location

Local Institution - 012-672

Offenbach, 63069, Germany

Location

Local Institution - 012-212

Oldenburg, 26121, Germany

Location

Local Institution - 012-502

Athens, Attica, 11526, Greece

Location

Local Institution - 012-236

Athens, 11527, Greece

Location

University General Hospital of Heraklion (PAGNI)

Heraklion, 71110, Greece

Location

Local Institution - 012-235

Larissa, 41110, Greece

Location

Local Institution - 012-237

Nea Kifissia, 145 64, Greece

Location

Local Institution - 012-234

Piraeus, 185 47, Greece

Location

Local Institution - 012-239

Piraeus, 185 47, Greece

Location

Local Institution - 012-504

Thessaloniki, 54622, Greece

Location

Local Institution - 012-230

Thessaloniki, 57001, Greece

Location

Local Institution - 012-500

Thessaloniki, 57010, Greece

Location

Local Institution - 012-503

Volos, 38333, Greece

Location

Local Institution - 012-048

Central, 0, Hong Kong

Location

Local Institution - 012-043

Hong Kong, 0, Hong Kong

Location

Local Institution - 012-040

Kowloon, 0, Hong Kong

Location

Local Institution - 012-242

Budapest, 1083, Hungary

Location

Local Institution - 012-244

Budapest, 1121, Hungary

Location

Local Institution - 012-241

Budapest, 1122, Hungary

Location

Local Institution - 012-243

Gyöngyös, 3200, Hungary

Location

Local Institution - 012-763

Gyula, 5700, Hungary

Location

Local Institution - 012-759

Székesfehérvár, 8000, Hungary

Location

Local Institution - 012-240

Törökbálint, 2045, Hungary

Location

Local Institution - 012-255

Tallaght, Dublin, D24 NR04, Ireland

Location

Local Institution - 012-250

Dublin, 4, Ireland

Location

Local Institution - 012-252

Dublin, 9, Ireland

Location

Local Institution - 012-259

Dublin, D08 NHY1, Ireland

Location

Local Institution - 012-257

Galway, H91 YR71, Ireland

Location

Local Institution - 012-258

Limerick, V94 F858, Ireland

Location

Local Institution - 012-276

Alessandria, 15121, Italy

Location

Local Institution - 012-292

Avellino, 83100, Italy

Location

Local Institution - 012-274

Aviano, 33081, Italy

Location

Local Institution - 012-275

Bari, 70124, Italy

Location

Local Institution - 012-765

Brescia, 25123, Italy

Location

Local Institution - 012-286

Candiolo, 10060, Italy

Location

Local Institution - 012-284

Catania, 95122, Italy

Location

Local Institution - 012-282

Catania, 95123, Italy

Location

Local Institution - 012-762

Florence, 50134, Italy

Location

Local Institution - 012-273

Genova, 16100, Italy

Location

Local Institution - 012-285

Genova, 16132, Italy

Location

Local Institution - 012-279

Lecce, 73100, Italy

Location

Local Institution - 012-270

Meldola, 47014, Italy

Location

Local Institution - 012-296

Milan, 20132, Italy

Location

Local Institution - 012-278

Milan, 20141, Italy

Location

Local Institution - 012-283

Milan, 20133, Italy

Location

Local Institution - 012-271

Naples, 80131, Italy

Location

Local Institution - 012-277

Naples, 80131, Italy

Location

Local Institution - 012-770

Novara, 28100, Italy

Location

Local Institution - 012-272

Parma, 43126, Italy

Location

Local Institution - 012-281

Perugia, 06132, Italy

Location

Local Institution - 012-766

Pesaro, 61122, Italy

Location

Local Institution - 012-767

Ravenna, 48121, Italy

Location

Local Institution - 012-295

Roma, 00144, Italy

Location

Local Institution - 012-758

Verona, 37126, Italy

Location

Local Institution - 012-306

Amsterdam, 1081 HV, Netherlands

Location

Local Institution - 012-309

Breda, 4818 CK, Netherlands

Location

Local Institution - 012-300

Maastricht, 6229 HX, Netherlands

Location

Local Institution - 012-630

Nijmegen, 6525 GA, Netherlands

Location

Local Institution - 012-308

The Hague, 2545 AA, Netherlands

Location

Local Institution - 012-307

Utrecht, 3543 AZ, Netherlands

Location

Local Institution - 012-631

Utrecht, 3584 CX, Netherlands

Location

Local Institution - 012-757

Lodz, 90-302, Poland

Location

Local Institution - 012-321

Lublin, 20-064, Poland

Location

Local Institution - 012-760

Lublin, 20-093, Poland

Location

Local Institution - 012-325

Otwock, 05-400, Poland

Location

Local Institution - 012-320

Rzeszów, 35-922, Poland

Location

Local Institution - 012-324

Skorzewo, 60-185, Poland

Location

Local Institution - 012-329

Torun, 87-100, Poland

Location

Local Institution - 012-322

Warsaw, 02-781, Poland

Location

Local Institution - 012-774

Warsaw, 04-349, Poland

Location

Local Institution - 012-644

Almada, 2805-267, Portugal

Location

Local Institution - 012-332

Braga, 4710-243, Portugal

Location

Local Institution - 012-330

Coimbra, 3000-075, Portugal

Location

Local Institution - 012-645

Coimbra, 3000-075, Portugal

Location

Local Institution - 012-333

Guimarães, 4835-044, Portugal

Location

Local Institution - 012-642

Lisbon, 1099-023, Portugal

Location

Local Institution - 012-338-A

Lisbon, 1350-352, Portugal

Location

Local Institution - 012-337

Lisbon, 1400-038, Portugal

Location

Local Institution - 012-338

Lisbon, 1998-018, Portugal

Location

Local Institution - 012-647

Loures, 2674-514, Portugal

Location

Local Institution - 012-334

Porto, 14341, Portugal

Location

Local Institution - 012-331

Porto, 4099-001, Portugal

Location

Local Institution - 012-339

Porto, 4200-072, Portugal

Location

Local Institution - 012-641

Santa Maria da Feira, 4520-211, Portugal

Location

Local Institution - 012-646

Setúbal, 2910-443, Portugal

Location

Local Institution - 012-335

Vila Nova de Gaia, 4434-502, Portugal

Location

Local Institution - 012-903

San Juan, PR, 00927, Puerto Rico

Location

Local Institution - 012-900

San Juan, PR, 00935, Puerto Rico

Location

Local Institution - 012-901

San Juan, 00919, Puerto Rico

Location

Local Institution - 012-347

Baia Mare, 430031, Romania

Location

Local Institution - 012-349

Brasov, 500152, Romania

Location

Local Institution - 012-341

Bucharest, 010991, Romania

Location

Local Institution - 012-342

Bucharest, 022328, Romania

Location

Local Institution - 012-344

Cluj-Napoca, 400015, Romania

Location

Local Institution - 012-340

Cluj-Napoca, 400641, Romania

Location

Local Institution - 012-514

Craiova, 200385, Romania

Location

Local Institution - 012-343

Craiova, 200746, Romania

Location

Local Institution - 012-513

Iași, 700106, Romania

Location

Local Institution - 012-519

Ovidiu, 905900, Romania

Location

Local Institution - 012-515

Timișoara, 300166, Romania

Location

Local Institution - 012-345

Timișoara, 300239, Romania

Location

Local Institution - 012-352

Chelyabinsk, 454048, Russia

Location

Local Institution - 012-351

Izhevsk, 426067, Russia

Location

Local Institution - 012-362

Kislino Village, 305524, Russia

Location

Local Institution - 012-353

Moscow, 121309, Russia

Location

Local Institution - 012-368

Moscow, 121467, Russia

Location

Local Institution - 012-359

Nizhny Novgorod, 603006, Russia

Location

Local Institution - 012-356

Novosibirsk, 630099, Russia

Location

Local Institution - 012-350

Omsk, 644013, Russia

Location

Local Institution - 012-355

Saint Petersburg, 197022, Russia

Location

Local Institution - 012-358

Saint Petersburg, 197376, Russia

Location

Local Institution - 012-354

Saint Petersburg, 197758, Russia

Location

Local Institution - 012-093

Singapore, 168583, Singapore

Location

Local Institution - 012-095

Singapore, 188770, Singapore

Location

Local Institution - 012-092

Singapore, 217562, Singapore

Location

Local Institution - 012-091

Singapore, 258499, Singapore

Location

Local Institution - 012-094

Singapore, 258500, Singapore

Location

Local Institution - 012-111

Busan, 48108, South Korea

Location

Local Institution - 012-522

Busan, 49241, South Korea

Location

Local Institution - 012-101

Busan, 602702, South Korea

Location

Local Institution - 012-113

Cheongju-si, 28644, South Korea

Location

Local Institution - 012-110

Daegu, 41404, South Korea

Location

Local Institution - 012-523

Daegu, 42601, South Korea

Location

Local Institution - 012-100

Hwasun-gun, 58128, South Korea

Location

Local Institution - 012-103

Incheon, 21565, South Korea

Location

Local Institution - 012-102

Junggu, 400-712, South Korea

Location

Local Institution - 012-520

Seongnam-si, 13496, South Korea

Location

Local Institution - 012-112

Seongnam-si, 13620, South Korea

Location

Local Institution - 012-105

Seoul, 02841, South Korea

Location

Local Institution - 012-118

Seoul, 03722, South Korea

Location

Local Institution - 012-106

Seoul, 05080, South Korea

Location

Local Institution - 012-104

Seoul, 05505, South Korea

Location

Local Institution - 012-109

Seoul, 06591, South Korea

Location

Local Institution - 012-521

Suwon, 16247, South Korea

Location

Local Institution - 012-107

Suwon, 16499, South Korea

Location

Local Institution - 012-611A

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 012-613

A Coruña, 15006, Spain

Location

Local Institution - 012-769

Alicante, 3010, Spain

Location

Local Institution - 012-610

Badalona, 08916, Spain

Location

Local Institution - 012-776

Barakaldo, 48903, Spain

Location

Local Institution - 012-761

Barcelona, 08003, Spain

Location

Local Institution - 012-614

Barcelona, 08028, Spain

Location

Local Institution - 012-612

Barcelona, 08035, Spain

Location

Local Institution - 012-600

Barcelona, 08036, Spain

Location

Local Institution - 012-621

Córdoba, 14004, Spain

Location

Local Institution - 012-764

Girona, 17007, Spain

Location

Local Institution - 012-616

Granada, 18014, Spain

Location

Local Institution - 012-628

Las Palmas de Gran Canaria, 35016, Spain

Location

Local Institution - 012-775

León, 24071, Spain

Location

Local Institution - 012-615

Lugo, 27003, Spain

Location

Local Institution - 012-607

Madrid, 28007, Spain

Location

Local Institution - 012-611

Madrid, 28027, Spain

Location

Local Institution - 012-606

Madrid, 28034, Spain

Location

Local Institution - 012-601

Madrid, 28040, Spain

Location

Local Institution - 012-609

Madrid, 28040, Spain

Location

Local Institution - 012-617

Madrid, 28041, Spain

Location

Local Institution - 012-626

Majadahonda, 28222, Spain

Location

Local Institution - 012-608

Málaga, 29009, Spain

Location

Local Institution - 012-602

Palma de Mallorca, 07120, Spain

Location

Local Institution - 012-604

Santander, 39008, Spain

Location

Local Institution - 012-629

Seville, 41013, Spain

Location

Local Institution - 012-625

Valencia, 46014, Spain

Location

Local Institution - 012-605

Valencia, 46026, Spain

Location

Local Institution - 012-603

Zaragoza, 50009, Spain

Location

Local Institution - 012-390

Basel, 4031, Switzerland

Location

Local Institution - 012-391

Thun, 3604, Switzerland

Location

Local Institution - 012-392

Winterthur, 8401, Switzerland

Location

Local Institution - 012-401

Birmingham, B9 5SS, United Kingdom

Location

Local Institution - 012-415

Edinburgh, EH4 2XU, United Kingdom

Location

Local Institution - 012-400

Glasgow, G12 0XH, United Kingdom

Location

Local Institution - 012-408

Leicester, LE1 5WW, United Kingdom

Location

Local Institution - 012-407

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

Interventions

adagrasibDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 28, 2020

Study Start

February 23, 2021

Primary Completion

December 30, 2023

Study Completion (Estimated)

October 30, 2026

Last Updated

August 11, 2026

Results First Posted

January 22, 2025

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations