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
2mo left

Started Feb 2021

Longer than P75 for phase_3

Geographic Reach
22 countries

335 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 Progress97%
Feb 2021Jul 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
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2026

Expected
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2.8 years

First QC Date

December 21, 2020

Results QC Date

December 20, 2024

Last Update Submit

January 20, 2025

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 (343)

Local Institution - 012-898

Cerritos, California, 90703, United States

Location

City of Hope - Duarte (Main Campus)

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

City Of Hope

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

Providence Medical Group - Santa Rosa

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

SCL Health - Saint Joseph Hospital Cancer Center

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

Holy Cross Health Fort Lauderdale - Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

21st Century Oncology of Jacksonville - North Lee Street

Jacksonville, Florida, 32204, United States

Location

Local Institution - 012-562-D

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

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Orlando Health University of Florida Health Cancer Center - Head and Neck Center

Orlando, Florida, 32806, United States

Location

USOR - Woodlands Medical Specialists

Pensacola, Florida, 32503, United States

Location

Local Institution - 012-839

Plantation, Florida, 33322, United States

Location

University Cancer & Blood Center (UCBC) - Athens

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

Northwest Georgia Oncology Centers Wellstar - Marietta

Marietta, Georgia, 30060, United States

Location

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612, United States

Location

University of Chicago

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

Illinois Cancer Specialists - Niles

Niles, Illinois, 60714, United States

Location

Local Institution - 012-972 B

Orland Park, Illinois, 60462, United States

Location

Goshen Center for Cancer Care

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

Franciscan Health Munster

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

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Local Institution - 012-911 A

New Orleans, Louisiana, 70112, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Local Institution - 012-954 - A

Kennebunk, Maine, 04043, United States

Location

New England Cancer Specialists - Scarborough

Scarborough, Maine, 04074, United States

Location

Local Institution - 012-954 - B

Topsham, Maine, 04086, United States

Location

Frederick Health

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

Ascension Providence Cancer Center - Southfield

Southfield, Michigan, 48075, United States

Location

Local Institution - 012-974-A

Southfield, Michigan, 48075, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

Local Institution - 012-841 - A

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Centers of Montana

Billings, Montana, 59101, United States

Location

Sisters of Charity of Leavenworth Health St. Marys

Billings, Montana, 59102, United States

Location

Astera Cancer Care - East Brunswick

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

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210-2306, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Kettering Health Cancer Center - Main Campus

Kettering, Ohio, 45429, United States

Location

Oregon Oncology Specialists

Salem, Oregon, 97301, United States

Location

Lifespan Cancer Institute - Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Local Institution - 012-960-A

Providence, Rhode Island, 02906, United States

Location

Prisma Health Cancer Institute - Faris Road

Greenville, South Carolina, 29605, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Texas Oncology - Dallas Fort Worth (DFW) - Arlington Cancer Center North

Arlington, Texas, 76012, United States

Location

Texas Oncology - Dallas Fort Worth (DFW) - South Austin

Austin, Texas, 78745, United States

Location

US Oncology Research (USOR)

Irving, Texas, 75063, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

Utah Cancer Specialists - UCS Cancer Center

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

UVA Health - University Hospital

Charlottesville, Virginia, 22908-0674, United States

Location

Local Institution - 012-814 - A

Fairfax, Virginia, 22031, United States

Location

NEXT Virginia

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

Townsville University Hospital

Douglas, 4814, Australia

Location

Local Institution - 012-013

St Leonards, 2065, Australia

Location

Local Institution - 012-019

Tweed Heads, 2485, Australia

Location

Cancer Care Wollongong

Wollongong, 2500, Australia

Location

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

Location

Klinikum Klagenfurt Am Worthersee

Klagenfurt, 9020, Austria

Location

Uniklinikum Salzburg

Salzburg, 5020, Austria

Location

Wiener Gesundheitsverbund - Klinik Ottakring

Vienna, 1160, Austria

Location

Universitair Ziekenhuis Brussel

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

Algemeen Ziekenhuis Glorieux Ronse

Ronse, 9600, Belgium

Location

Local Institution - 012-150

Yvoir, B-5530, Belgium

Location

Local Institution - 012-164

Hořovice, 268 31, Czechia

Location

Local Institution - 012-162

Olomouc, 779 00, Czechia

Location

Vseobecna Fakultni Nemocnice v Praze

Prague, 128 08, Czechia

Location

Fakultni nemocnice Bulovka

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

Hopital Louis Pradel

Bron, 69500, France

Location

Local Institution - 012-193

Caen, 14033, France

Location

Local Institution - 012-196

Caen, 14076, France

Location

Centre Hospitalier Intercommunal de Creteil

Créteil, 94000, France

Location

Local Institution - 012-192

Dijon, 21079, France

Location

LHopital Nord-Ouest (HNO) - Villefranche-sur-Saone

Gleizé, 69400, France

Location

Hopital Michallon

La Tronche, 38700, France

Location

Centre Hospitalier Regional Universitaire de Lille

Lille, 59037, France

Location

Centre Hospitalier Universitaire Dupuytren 1

Limoges, 87042, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Hopital Nord de Marseille

Marseille, 13015, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34090, France

Location

Hopital Emile Muller

Mulhouse, 68100, France

Location

Local Institution - 012-685

Nice, 06189, France

Location

Centre Hospitalier de Cornouaille - Hopital Laennec

Quimper, 29107, France

Location

Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau

Saint-Herblain, 44805, France

Location

Hopital Civil

Strasbourg, 67091, France

Location

Local Institution - 012-197

Strasbourg, 67200, France

Location

Hopital Bretonneau

Tours, 37044, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Local Institution - 012-219

Bad Berka, 99437, Germany

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Klinikum Koln-Merheim

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

LungenClinic Grosshansdorf

Grohansdorf, 22927, Germany

Location

Local Institution - 012-215

Halle, 06120, Germany

Location

Universitatsklinikum Jena

Jena, 07747, Germany

Location

Klinikum Kassel

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

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Henry Dunant Hospital Center

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

"General Oncology Hospital of Kifisias "Agioi Anargyroi""

Nea Kifissia, 145 64, Greece

Location

Local Institution - 012-234

Piraeus, 185 47, Greece

Location

Metropolitan Hospital

Piraeus, 185 47, Greece

Location

BioClinic Thessaloniki

Thessaloniki, 54622, Greece

Location

Local Institution - 012-230

Thessaloniki, 57001, Greece

Location

Local Institution - 012-500

Thessaloniki, 57010, Greece

Location

Anassa General Clinic

Volos, 38333, Greece

Location

Humanity & Health Clinical Trial Centre

Central, 0, Hong Kong

Location

Prince of Wales Hospital - Hong Kong

Hong Kong, 0, Hong Kong

Location

Hong Kong United Oncology Centre

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

Reformatus Pulmonologiai Centrum

Törökbálint, 2045, Hungary

Location

The Meath Foundation

Tallaght, Dublin, D24 NR04, Ireland

Location

St. Vincents University Hospital

Dublin, 4, Ireland

Location

Beaumont Hospital - Dublin

Dublin, 9, Ireland

Location

St. Jamess Hospital

Dublin, D08 NHY1, Ireland

Location

University Hospital Galway

Galway, H91 YR71, Ireland

Location

University Hospital Limerick

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

"Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST"

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

Napoli, 80131, Italy

Location

Local Institution - 012-277

Napoli, 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

Amphia Ziekenhuis - Breda Molengracht

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

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Instytut MSF

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

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, 87-100, Poland

Location

Local Institution - 012-322

Warsaw, 02-781, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 04-349, Poland

Location

Unidade Local de Saude de Almada-Seixal, E. P. E (Hospital Garcia de Orta)

Almada, 2805-267, Portugal

Location

Unidade Local de Saude de Braga, E. P. E (Hospital de Braga)

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

The Champalimaud Centre for the Unknown

Lisbon, 1400-038, Portugal

Location

Local Institution - 012-338

Lisbon, 1998-018, Portugal

Location

Unidade Local de Saude de Loures-Odivelas, EPE (Hospital Beatriz Angelo)

Loures, 2674-514, Portugal

Location

Hospital CUF Porto

Porto, 14341, Portugal

Location

Local Institution - 012-331

Porto, 4099-001, Portugal

Location

Local Institution - 012-339

Porto, 4200-072, Portugal

Location

Unidade Local de Saude de Entre Douro e Vouga, E. P. E

Santa Maria da Feira, 4520-211, Portugal

Location

Unidade Local de Saude da Arrabida, E. P. E (Centro Hospitalar de Setubal)

Setúbal, 2910-443, Portugal

Location

Unidade Local de Saude de Gaia/Espinho, E. P. E

Vila Nova de Gaia, 4434-502, Portugal

Location

Puerto Rico Medical Research Center

San Juan, 00919, Puerto Rico

Location

FDI Clinical Research (Fundacion de Investigacion de Diego) - San Juan

San Juan, 00927, Puerto Rico

Location

PanOncology Trials - Rio Piedras Medical Center

San Juan, 00935, Puerto Rico

Location

Spitalul Jude�ean de Urgen�a dr. Constantin Opri� Baia Mare

Baia Mare, 430031, Romania

Location

SC Policlinica de Diagnostic Rapid SA

Brasov, 500152, Romania

Location

Centrul Oncologic Sanador

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

Oncolab Craiova

Craiova, 200385, Romania

Location

Local Institution - 012-343

Craiova, 200746, Romania

Location

Local Institution - 012-513

Iași, 700106, Romania

Location

Ovidius Clinical Hospital

Ovidiu, 905900, Romania

Location

Oncocenter - Oncologie Clinica

Timișoara, 300166, Romania

Location

SC OncoMed SRL

Timișoara, 300239, Romania

Location

Evimed Oncology Clinic

Chelyabinsk, 454048, Russia

Location

"Budgetary Healthcare Institution of the Udmurt Republic "Republican Clinical Oncological Dispensary n.a. Sergey Grigoryevich Pr

Izhevsk, 426067, Russia

Location

"Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical Center" of the Healthcare C

Kislino Village, 305524, Russia

Location

VitaMed - Moscow

Moscow, 121309, Russia

Location

University Headache Clinic

Moscow, 121467, Russia

Location

State Budgetary Healthcare Institution of the Nizhny Novgorod Region Clinical Diagnostic Center

Nizhny Novgorod, 603006, Russia

Location

"Limited Liability Company Medical Sanitary Unit "Clinicist-Clinic Pretor""

Novosibirsk, 630099, Russia

Location

"Budgetary Healthcare Institution of Omsk region "Clinical Oncologic Dispensary""

Omsk, 644013, Russia

Location

Local Institution - 012-355

Saint Petersburg, 197022, Russia

Location

"Federal State Budgetary Institution "Influenza Research Institute named after N.N. A.A. Smorodintsev" of the Ministry of Health

Saint Petersburg, 197376, Russia

Location

Local Institution - 012-354

Saint Petersburg, 197758, Russia

Location

Local Institution - 012-093

Singapore, 168583, Singapore

Location

Raffles Hospital

Singapore, 188770, Singapore

Location

Icon Cancer Centre Farrer Park

Singapore, 217562, Singapore

Location

Oncocare Cancer Centre

Singapore, 258499, Singapore

Location

Parkway Cancer Centre - Gleneagles Hospital

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

Chungbuk National University Hospital

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

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Local Institution - 012-118

Seoul, 03722, South Korea

Location

Local Institution - 012-106

Seoul, 05080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea - Seoul St. Marys Hospital

Seoul, 06591, South Korea

Location

Catholic University of Korea St. Vincents Hospital

Suwon, 16247, South Korea

Location

Local Institution - 012-107

Suwon, 16499, South Korea

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 012-613

A Coruña, 15006, Spain

Location

Local Institution - 012-769

Alicante, 3010, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Local Institution - 012-776

Barakaldo, 48903, Spain

Location

Hospital del Mar - Parc de Salut Mar

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

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital de Leon

León, 24071, Spain

Location

Local Institution - 012-615

Lugo, 27003, Spain

Location

Local Institution - 012-607

Madrid, 28007, Spain

Location

Clinica Universidad de Navarra - Madrid

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

Hospital Universitario 12 de Octubre

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

Consorci Hospital General Universitari de Valencia

Valencia, 46014, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Local Institution - 012-603

Zaragoza, 50009, Spain

Location

Universitatsspital Basel

Basel, 4031, Switzerland

Location

Spital Simmental-Thun-Saanenland

Thun, 3604, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

NHS Lothian

Edinburgh, EH4 2XU, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, G12 0XH, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

The Christie NHS Foundation Trust

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)

July 2, 2026

Last Updated

January 22, 2025

Results First Posted

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations