Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
NCT ID: NCT04685135
Last Updated: 2025-01-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
453 participants
INTERVENTIONAL
2021-02-23
2026-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MRTX849
MRTX849
21 day cycles
Docetaxel
Docetaxel
21 day cycles
Interventions
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MRTX849
21 day cycles
Docetaxel
21 day cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidacy to receive treatment with docetaxel.
* Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
* ECOG performance status 0-2
Exclusion Criteria
* Active brain metastases.
* Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 012-898
Cerritos, California, United States
City of Hope - Duarte (Main Campus)
Duarte, California, United States
Local Institution - 012-898 D
Glendale, California, United States
Local Institution - 012-910-A
Huntington Beach, California, United States
Local Institution - 012-910-C
Irvine, California, United States
City Of Hope
Long Beach, California, United States
Local Institution - 012-910-F
Long Beach, California, United States
Local Institution - 012-910-D
Newport Beach, California, United States
Local Institution - 012-898 C
Santa Ana, California, United States
Providence Medical Group - Santa Rosa
Santa Rosa, California, United States
Local Institution - 012-910-E
Torrance, California, United States
Local Institution - 012-951-B
Denver, Colorado, United States
SCL Health - Saint Joseph Hospital Cancer Center
Lafayette, Colorado, United States
Local Institution - 012-872
Lone Tree, Colorado, United States
Local Institution - 012-951-A
Wheat Ridge, Colorado, United States
Local Institution - 012-562-B
Fleming Island, Florida, United States
Holy Cross Health Fort Lauderdale - Holy Cross Hospital
Fort Lauderdale, Florida, United States
21st Century Oncology of Jacksonville - North Lee Street
Jacksonville, Florida, United States
Local Institution - 012-562-D
Jacksonville, Florida, United States
Local Institution - 012-562-E
Jacksonville, Florida, United States
Local Institution - 012-562-A
Jacksonville, Florida, United States
Local Institution - 012-562-C
Jacksonville, Florida, United States
Local Institution - 012-562-F
Jacksonville, Florida, United States
Local Institution - 012-562-G
Jacksonville, Florida, United States
Local Institution - 012-562
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Orlando Health University of Florida Health Cancer Center - Head and Neck Center
Orlando, Florida, United States
USOR - Woodlands Medical Specialists
Pensacola, Florida, United States
Local Institution - 012-839
Plantation, Florida, United States
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, United States
Local Institution - 012-835 - A
Austell, Georgia, United States
Local Institution - 012-835 - B
Carrollton, Georgia, United States
Local Institution - 012-835 - C
Cartersville, Georgia, United States
Local Institution - 012-835 - D
Douglasville, Georgia, United States
Northwest Georgia Oncology Centers Wellstar - Marietta
Marietta, Georgia, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Local Institution - 012-972 C
Harvey, Illinois, United States
Local Institution - 012-972 A
New Lenox, Illinois, United States
Illinois Cancer Specialists - Niles
Niles, Illinois, United States
Local Institution - 012-972 B
Orland Park, Illinois, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
Local Institution - 012-569
Indianapolis, Indiana, United States
Local Institution - 012-569 - B
Lafayette, Indiana, United States
Local Institution - 012-569 - C
Lafayette, Indiana, United States
Local Institution - 012-569 - A
Mooresville, Indiana, United States
Franciscan Health Munster
Munster, Indiana, United States
Local Institution - 012-942-B
Chanute, Kansas, United States
Local Institution - 012-942-C
Dodge City, Kansas, United States
Local Institution - 012-942-D
El Dorado, Kansas, United States
Local Institution - 012-942-E
Independence, Kansas, United States
Local Institution - 012-942-F
Kingman, Kansas, United States
Local Institution - 012-942-G
Liberal, Kansas, United States
Local Institution - 012-942-H
McPherson, Kansas, United States
Local Institution - 012-942-I
Newton, Kansas, United States
Local Institution - 012-942-J
Parsons, Kansas, United States
Local Institution - 012-942-K
Pratt, Kansas, United States
Local Institution - 012-942-L
Salina, Kansas, United States
Local Institution - 012-942-M
Wellington, Kansas, United States
Local Institution - 012-820
Westwood, Kansas, United States
Local Institution - 012-942-A
Wichita, Kansas, United States
Local Institution - 012-942
Wichita, Kansas, United States
Local Institution - 012-942-N
Winfield, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Local Institution - 012-911 A
New Orleans, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
Local Institution - 012-954 - A
Kennebunk, Maine, United States
New England Cancer Specialists - Scarborough
Scarborough, Maine, United States
Local Institution - 012-954 - B
Topsham, Maine, United States
Frederick Health
Frederick, Maryland, United States
Local Institution - 012-974-B
Novi, Michigan, United States
Local Institution - 012-974-C
Novi, Michigan, United States
Ascension Providence Cancer Center - Southfield
Southfield, Michigan, United States
Local Institution - 012-974-A
Southfield, Michigan, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Local Institution - 012-841 - A
Billings, Montana, United States
St. Vincent Healthcare Cancer Centers of Montana
Billings, Montana, United States
Sisters of Charity of Leavenworth Health St. Marys
Billings, Montana, United States
Astera Cancer Care - East Brunswick
East Brunswick, New Jersey, United States
Local Institution - 012-975 - A
Edison, New Jersey, United States
Local Institution - 012-975 - B
Monroe, New Jersey, United States
Local Institution - 012-975 - C
Somerset, New Jersey, United States
Local Institution - 012-975 - D
Somerville, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Kettering Health Cancer Center - Main Campus
Kettering, Ohio, United States
Oregon Oncology Specialists
Salem, Oregon, United States
Lifespan Cancer Institute - Rhode Island Hospital
Providence, Rhode Island, United States
Local Institution - 012-960-A
Providence, Rhode Island, United States
Prisma Health Cancer Institute - Faris Road
Greenville, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Texas Oncology - Dallas Fort Worth (DFW) - Arlington Cancer Center North
Arlington, Texas, United States
Texas Oncology - Dallas Fort Worth (DFW) - South Austin
Austin, Texas, United States
US Oncology Research (USOR)
Irving, Texas, United States
Texas Oncology - Sherman
Sherman, Texas, United States
Utah Cancer Specialists - UCS Cancer Center
Salt Lake City, Utah, United States
Local Institution - 012-976-A
Salt Lake City, Utah, United States
Local Institution - 012-976-B
Salt Lake City, Utah, United States
Local Institution - 012-976-C
Salt Lake City, Utah, United States
Local Institution - 012-976-D
Salt Lake City, Utah, United States
Local Institution - 012-976-E
Salt Lake City, Utah, United States
Local Institution - 012-976-F
Salt Lake City, Utah, United States
Local Institution - 012-976-G
Salt Lake City, Utah, United States
Local Institution - 012-976-H
Salt Lake City, Utah, United States
Local Institution - 012-976-I
Salt Lake City, Utah, United States
Local Institution - 012-814 - B
Arlington, Virginia, United States
UVA Health - University Hospital
Charlottesville, Virginia, United States
Local Institution - 012-814 - A
Fairfax, Virginia, United States
NEXT Virginia
Fairfax, Virginia, United States
Local Institution - 012-814 - C
Gainesville, Virginia, United States
Local Institution - 012-814 - D
Leesburg, Virginia, United States
Local Institution - 012-016
Mackay, Queensland, Australia
Local Institution - 012-005
Bedford Park, , Australia
Local Institution - 012-004
Clayton, , Australia
Townsville University Hospital
Douglas, , Australia
Local Institution - 012-013
St Leonards, , Australia
Local Institution - 012-019
Tweed Heads, , Australia
Cancer Care Wollongong
Wollongong, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Klinikum Klagenfurt Am Worthersee
Klagenfurt, , Austria
Uniklinikum Salzburg
Salzburg, , Austria
Wiener Gesundheitsverbund - Klinik Ottakring
Vienna, , Austria
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Local Institution - 012-157
Edegem, , Belgium
Local Institution - 012-155
Ghent, , Belgium
Local Institution - 012-151
Gilly, , Belgium
Local Institution - 012-158
Hasselt, , Belgium
Local Institution - 012-152
Roeselare, , Belgium
Algemeen Ziekenhuis Glorieux Ronse
Ronse, , Belgium
Local Institution - 012-150
Yvoir, , Belgium
Local Institution - 012-164
Hořovice, , Czechia
Local Institution - 012-162
Olomouc, , Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice Bulovka
Praha 8 - Liben, , Czechia
Local Institution - 012-191-A
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Local Institution - 012-191-B
Lyon, Rhone, France
Local Institution - 012-194
Brest, , France
Hopital Louis Pradel
Bron, , France
Local Institution - 012-193
Caen, , France
Local Institution - 012-196
Caen, , France
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Local Institution - 012-192
Dijon, , France
LHopital Nord-Ouest (HNO) - Villefranche-sur-Saone
Gleizé, , France
Hopital Michallon
La Tronche, , France
Centre Hospitalier Regional Universitaire de Lille
Lille, , France
Centre Hospitalier Universitaire Dupuytren 1
Limoges, , France
Institut Paoli-Calmettes
Marseille, , France
Hopital Nord de Marseille
Marseille, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Hopital Emile Muller
Mulhouse, , France
Local Institution - 012-685
Nice, , France
Centre Hospitalier de Cornouaille - Hopital Laennec
Quimper, , France
Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau
Saint-Herblain, , France
Hopital Civil
Strasbourg, , France
Local Institution - 012-197
Strasbourg, , France
Hopital Bretonneau
Tours, , France
Gustave Roussy
Villejuif, , France
Local Institution - 012-219
Bad Berka, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Klinikum Koln-Merheim
Cologne, , Germany
Local Institution - 012-210
Essen, , Germany
Local Institution - 012-214
Gauting, , Germany
Local Institution - 012-671
Giessen, , Germany
LungenClinic Grosshansdorf
Grohansdorf, , Germany
Local Institution - 012-215
Halle, , Germany
Universitatsklinikum Jena
Jena, , Germany
Klinikum Kassel
Kassel, , Germany
Local Institution - 012-224
Löwenstein, , Germany
Local Institution - 012-216
Lübeck, , Germany
Local Institution - 012-220
München, , Germany
Local Institution - 012-672
Offenbach, , Germany
Pius-Hospital Oldenburg
Oldenburg, , Germany
Henry Dunant Hospital Center
Athens, Attica, Greece
Local Institution - 012-236
Athens, , Greece
University General Hospital of Heraklion (PAGNI)
Heraklion, , Greece
Local Institution - 012-235
Larissa, , Greece
"General Oncology Hospital of Kifisias "Agioi Anargyroi""
Nea Kifissia, , Greece
Local Institution - 012-234
Piraeus, , Greece
Metropolitan Hospital
Piraeus, , Greece
BioClinic Thessaloniki
Thessaloniki, , Greece
Local Institution - 012-230
Thessaloniki, , Greece
Local Institution - 012-500
Thessaloniki, , Greece
Anassa General Clinic
Volos, , Greece
Humanity & Health Clinical Trial Centre
Central, , Hong Kong
Prince of Wales Hospital - Hong Kong
Hong Kong, , Hong Kong
Hong Kong United Oncology Centre
Kowloon, , Hong Kong
Local Institution - 012-242
Budapest, , Hungary
Local Institution - 012-244
Budapest, , Hungary
Local Institution - 012-241
Budapest, , Hungary
Local Institution - 012-243
Gyöngyös, , Hungary
Local Institution - 012-763
Gyula, , Hungary
Local Institution - 012-759
Székesfehérvár, , Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, , Hungary
The Meath Foundation
Tallaght, Dublin, Ireland
St. Vincents University Hospital
Dublin, , Ireland
Beaumont Hospital - Dublin
Dublin, , Ireland
St. Jamess Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
University Hospital Limerick
Limerick, , Ireland
Local Institution - 012-276
Alessandria, , Italy
Local Institution - 012-292
Avellino, , Italy
Local Institution - 012-274
Aviano, , Italy
Local Institution - 012-275
Bari, , Italy
Local Institution - 012-765
Brescia, , Italy
Local Institution - 012-286
Candiolo, , Italy
Local Institution - 012-284
Catania, , Italy
Local Institution - 012-282
Catania, , Italy
Local Institution - 012-762
Florence, , Italy
Local Institution - 012-273
Genova, , Italy
Local Institution - 012-285
Genova, , Italy
Local Institution - 012-279
Lecce, , Italy
"Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST"
Meldola, , Italy
Local Institution - 012-296
Milan, , Italy
Local Institution - 012-278
Milan, , Italy
Local Institution - 012-283
Milan, , Italy
Local Institution - 012-271
Napoli, , Italy
Local Institution - 012-277
Napoli, , Italy
Local Institution - 012-770
Novara, , Italy
Local Institution - 012-272
Parma, , Italy
Local Institution - 012-281
Perugia, , Italy
Local Institution - 012-766
Pesaro, , Italy
Local Institution - 012-767
Ravenna, , Italy
Local Institution - 012-295
Roma, , Italy
Local Institution - 012-758
Verona, , Italy
Local Institution - 012-306
Amsterdam, , Netherlands
Amphia Ziekenhuis - Breda Molengracht
Breda, , Netherlands
Local Institution - 012-300
Maastricht, , Netherlands
Local Institution - 012-630
Nijmegen, , Netherlands
Local Institution - 012-308
The Hague, , Netherlands
Local Institution - 012-307
Utrecht, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Instytut MSF
Lodz, , Poland
Local Institution - 012-321
Lublin, , Poland
Local Institution - 012-760
Lublin, , Poland
Local Institution - 012-325
Otwock, , Poland
Local Institution - 012-320
Rzeszów, , Poland
Local Institution - 012-324
Skorzewo, , Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, , Poland
Local Institution - 012-322
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Unidade Local de Saude de Almada-Seixal, E. P. E (Hospital Garcia de Orta)
Almada, , Portugal
Unidade Local de Saude de Braga, E. P. E (Hospital de Braga)
Braga, , Portugal
Local Institution - 012-330
Coimbra, , Portugal
Local Institution - 012-645
Coimbra, , Portugal
Local Institution - 012-333
Guimarães, , Portugal
Local Institution - 012-642
Lisbon, , Portugal
Local Institution - 012-338-A
Lisbon, , Portugal
The Champalimaud Centre for the Unknown
Lisbon, , Portugal
Local Institution - 012-338
Lisbon, , Portugal
Unidade Local de Saude de Loures-Odivelas, EPE (Hospital Beatriz Angelo)
Loures, , Portugal
Hospital CUF Porto
Porto, , Portugal
Local Institution - 012-331
Porto, , Portugal
Local Institution - 012-339
Porto, , Portugal
Unidade Local de Saude de Entre Douro e Vouga, E. P. E
Santa Maria da Feira, , Portugal
Unidade Local de Saude da Arrabida, E. P. E (Centro Hospitalar de Setubal)
Setúbal, , Portugal
Unidade Local de Saude de Gaia/Espinho, E. P. E
Vila Nova de Gaia, , Portugal
Puerto Rico Medical Research Center
San Juan, , Puerto Rico
FDI Clinical Research (Fundacion de Investigacion de Diego) - San Juan
San Juan, , Puerto Rico
PanOncology Trials - Rio Piedras Medical Center
San Juan, , Puerto Rico
Spitalul Jude�ean de Urgen�a dr. Constantin Opri� Baia Mare
Baia Mare, , Romania
SC Policlinica de Diagnostic Rapid SA
Brasov, , Romania
Centrul Oncologic Sanador
Bucharest, , Romania
Local Institution - 012-342
Bucharest, , Romania
Local Institution - 012-344
Cluj-Napoca, , Romania
Local Institution - 012-340
Cluj-Napoca, , Romania
Oncolab Craiova
Craiova, , Romania
Local Institution - 012-343
Craiova, , Romania
Local Institution - 012-513
Iași, , Romania
Ovidius Clinical Hospital
Ovidiu, , Romania
Oncocenter - Oncologie Clinica
Timișoara, , Romania
SC OncoMed SRL
Timișoara, , Romania
Evimed Oncology Clinic
Chelyabinsk, , Russia
"Budgetary Healthcare Institution of the Udmurt Republic "Republican Clinical Oncological Dispensary n.a. Sergey Grigoryevich Pr
Izhevsk, , Russia
"Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical Center" of the Healthcare C
Kislino Village, , Russia
VitaMed - Moscow
Moscow, , Russia
University Headache Clinic
Moscow, , Russia
State Budgetary Healthcare Institution of the Nizhny Novgorod Region Clinical Diagnostic Center
Nizhny Novgorod, , Russia
"Limited Liability Company Medical Sanitary Unit "Clinicist-Clinic Pretor""
Novosibirsk, , Russia
"Budgetary Healthcare Institution of Omsk region "Clinical Oncologic Dispensary""
Omsk, , Russia
Local Institution - 012-355
Saint Petersburg, , Russia
"Federal State Budgetary Institution "Influenza Research Institute named after N.N. A.A. Smorodintsev" of the Ministry of Health
Saint Petersburg, , Russia
Local Institution - 012-354
Saint Petersburg, , Russia
Local Institution - 012-093
Singapore, , Singapore
Raffles Hospital
Singapore, , Singapore
Icon Cancer Centre Farrer Park
Singapore, , Singapore
Oncocare Cancer Centre
Singapore, , Singapore
Parkway Cancer Centre - Gleneagles Hospital
Singapore, , Singapore
Local Institution - 012-111
Busan, , South Korea
Local Institution - 012-522
Busan, , South Korea
Local Institution - 012-101
Busan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Local Institution - 012-110
Daegu, , South Korea
Local Institution - 012-523
Daegu, , South Korea
Local Institution - 012-100
Hwasun-gun, , South Korea
Local Institution - 012-103
Incheon, , South Korea
Local Institution - 012-102
Junggu, , South Korea
Local Institution - 012-520
Seongnam-si, , South Korea
Local Institution - 012-112
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Local Institution - 012-118
Seoul, , South Korea
Local Institution - 012-106
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea - Seoul St. Marys Hospital
Seoul, , South Korea
Catholic University of Korea St. Vincents Hospital
Suwon, , South Korea
Local Institution - 012-107
Suwon, , South Korea
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain
Local Institution - 012-613
A Coruña, , Spain
Local Institution - 012-769
Alicante, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Local Institution - 012-776
Barakaldo, , Spain
Hospital del Mar - Parc de Salut Mar
Barcelona, , Spain
Local Institution - 012-614
Barcelona, , Spain
Local Institution - 012-612
Barcelona, , Spain
Local Institution - 012-600
Barcelona, , Spain
Local Institution - 012-621
Córdoba, , Spain
Local Institution - 012-764
Girona, , Spain
Local Institution - 012-616
Granada, , Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, , Spain
Hospital de Leon
León, , Spain
Local Institution - 012-615
Lugo, , Spain
Local Institution - 012-607
Madrid, , Spain
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Local Institution - 012-606
Madrid, , Spain
Local Institution - 012-601
Madrid, , Spain
Local Institution - 012-609
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Local Institution - 012-626
Majadahonda, , Spain
Local Institution - 012-608
Málaga, , Spain
Local Institution - 012-602
Palma de Mallorca, , Spain
Local Institution - 012-604
Santander, , Spain
Local Institution - 012-629
Seville, , Spain
Consorci Hospital General Universitari de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Local Institution - 012-603
Zaragoza, , Spain
Universitatsspital Basel
Basel, , Switzerland
Spital Simmental-Thun-Saanenland
Thun, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
NHS Lothian
Edinburgh, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA239-0013
Identifier Type: OTHER
Identifier Source: secondary_id
849-012
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0013
Identifier Type: -
Identifier Source: org_study_id
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