Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
NCT ID: NCT05853575
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-02-16
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Adagrasib 600mg BID
Adagrasib 600mg BID without regard to food
Adagrasib
KRAS G12C inhibitor
Adagrasib 400mg BID
Adagrasib 400mg BID with food
Adagrasib
KRAS G12C inhibitor
Interventions
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Adagrasib
KRAS G12C inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
* Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
* Have recovered from their prior treatment and blood tests are within a safe range.
Exclusion Criteria
* Have cancer that can potentially be removed with surgery.
* Patients with brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
* Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
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 - 751
Belgrade, , Serbia
Local Institution - 101
Santa Rosa, California, United States
Local Institution - 104
Chicago, Illinois, United States
Local Institution - 103
Minneapolis, Minnesota, United States
Kansas City VA Hospital
Kansas City, Missouri, United States
Veterans Affairs Medical Center (VAMC) - Durham - Oncology
Durham, North Carolina, United States
VA North Texas Healthcare System/Dallas VA Medical Center
Dallas, Texas, United States
Ensino e Terapia de Inovação Clinica AMO-ÉTICA / Ética Pesquisa e Ensino
Salvador, Estado de Bahia, Brazil
Uniao Brasileira de Educacao E Assistencia
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Oncocentro Belo Horizonte
Belo Horizonte, São Paulo, Brazil
A.C. Camargo Cancer Center
São Paulo, , Brazil
A.C. Camargo Cancer Center
São Paulo, , Brazil
Klinički bolnički centar Sestre milosrdnice
Zagreb, City of Zagreb, Croatia
Local Institution - 525
Pula, Istria County, Croatia
Specijalna Bolnica Medico - Rijeka
Rijeka, Primorje-Gorski Kotar County, Croatia
CHU de Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Hopital Haut-Leveque - Maladies respiratoires
Pessac, Gironde, France
Institut de Cancerologie de I'Ouest - Service d'Oncologie Medicale - Service d'Oncologie Médicale
Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier Universitaire D' Angers Hôpital Larrey - PNEUMOLOGIE - Département de PNEUMOLOGIE
Angers, Maine-et-Loire, France
CHU de Nantes - Hôpital Nord LaÃ"nnec (HGRL) - Service dOncologie medicale â€" Unite dOncologie thoracique
Nantes, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Poitiers - Service d'oncologie Médicale Oncologie Medicale - Cancerolo
Poitiers, Poitou-Charentes, France
Centre Hospitalier Universitaire de Nice
Nice, Provence-Alpes-Côte d'Azur Region, France
AP-HM Hopital Nord
Marseille, Rhône, France
Centre Hosptalier De Villefranche-Sur-Saone - Oncologie Medicale - Cancerolo
Villefranche-sur-Saône, Rhône, France
Centre Hôspitalier de Bretagne Sud - Hôpital du Scorff
Lorient, , France
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Paris, , France
Centre Hospitalier de Cornouaille
Quimper, , France
Hôpital Bégin - Service d'Oncologie
Saint-Mandé, , France
Local Institution - 577
Pátrai, Achaïa, Greece
General Hospital of Athens "Alexandra"
Athens, Attica, Greece
Local Institution - 582
Athens, Attica, Greece
Attikon Hospital - 2nd Critical Care
Haidari - Athens, Pella, Greece
St. Luke's Hospital S.A.
Panórama, , Greece
Theageneio Cancer Hospital
Thessaloniki, , Greece
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, , Greece
Local Institution - 600
Szolnok, Jász-Nagykun-Szolnok, Hungary
Local Institution - 603
Debrecen, , Hungary
Shaare Zedek Medical center
Jerusalem, Jerusalem, Israel
Bnai Zion Medical Center Rheumatology Unit
Haifa, Tel Aviv, Israel
Assuta Medical Center
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus
Haifa, , Israel
Tel Aviv Sourasky Medical Center - Oncology - Hematology/Oncology
Tel Aviv, , Israel
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
Pesaro, Pesaro E Urbino, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Piedmont, Italy
Istituto di Candiolo, IRCCS
Candiolo, Torino, Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, , Italy
Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia
Perugia, , Italy
Istituto Nazionale Tumori Regina Elena - IRCCS - IFO
Roma, , Italy
Ehime University Hospital
Tōon, Ehime, Japan
Local Institution - 403
Nishinomiya, Hyôgo [Hyogo], Japan
National Cancer Center Hospital East
Kashiwa, Tiba [Chiba], Japan
Local Institution - 400
Osaka, Ôsaka [Osaka], Japan
Local Institution - 128
Tuxtla Gutiérrez, Chiapas, Mexico
Local Institution - 129
Colonia Nápoles, Mexico City, Mexico
Local Institution - 127
Colonia Roma, Mexico City, Mexico
Local Institution - 125
Toluca, , Mexico
Local Institution - 802
Breda, North Brabant, Netherlands
Anthoni van Leeuwenhoek Ziekenhuis, Nederlands Kanker Instit
Amsterdam, North Holland, Netherlands
St. Antonius Hospital
Utrecht, , Netherlands
Local Institution - 152
San Martín de Porres, Lima region, Peru
Local Institution - 151
Surquillo, Lima region, Peru
Local Institution - 650
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 651
Gdynia, Pomeranian Voivodeship, Poland
Local Institution - 653
Lublin, , Poland
Medisprof - Medical Oncology
Cluj-Napoca, Cluj, Romania
Ovidius Clinical Hospital
Ovidiu, Constanța County, Romania
Local Institution - 727
Craiova, Dolj, Romania
Oncolab - Medical Oncology
Craiova, Dolj, Romania
Centrul de Oncologie Sf Nectarie - Medical Oncology
Craiova, Dolj, Romania
Oncocenter- Oncologie Clinica - Medical Oncology
Timișoara, Timiș County, Romania
Local Institution - 726
Bucharest, , Romania
Centrul de Oncologie Euroclinic
Iași, , Romania
Spitalul Clinic Judetean De Urgenta Sibiu
Sibiu, , Romania
Sigmedical Services S.R.L.
Suceava, , Romania
Local Institution - 750
Kamenitz, Vojvodina, Serbia
University Clinical Center of Nis, Clinic for Pediatrics-Department for Pulmonology
Nis, Vojvodina, Serbia
Local Institution - 753
Belgrade, , Serbia
University Clinical Center of Kragujevac, Center for Internal Oncology
Kragujevac, Šumadijski Okrug, Serbia
National Cancer Center
Goyang-si, Gyeonggido [Kyonggi-do], South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
Local Institution - 328
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Local Institution - 326
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea
Complejo Hospitalario Universitario De Santiago - Oncología Médica
Santiago de Compostela, A Coruña, Spain
Hospital Regional Universitario De Málaga
Málaga, Andalusia, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Local Institution - 686
Santander, Cantabria, Spain
Local Institution - 676
Oviedo, Principality of Asturias, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, , Spain
Hospital Universitario Vall d'Hebron - Oncología Médica
Barcelona, , Spain
Local Institution - 689
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Local Institution - 679
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Virgen de la Macarena - Oncología Médica
Seville, , Spain
Hospital Clinico Universitario De Valencia - Oncologia Médica y Hematologia
Valencia, , Spain
Local Institution - 684
Valencia, , Spain
Local Institution - 351
Kaohsiung City, Kaohsiung, Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Kaohsuing City, Kaohsiung, Taiwan
Chung Shan Medical University Hospital - Internal Medicine
Taichung, Taichung, Taiwan
China Medical University Hospital - Internal Medicine
Taichung, Taichung, Taiwan
China Medical University Hospital - Internal Medicine
Taichung, Taichung, Taiwan
Local Institution - 355
Taichung, Taichung, Taiwan
Local Institution - 354
Taipei City, Taipei, Taiwan
Local Institution - 376
Muang, Chiang Mai, Thailand
Local Institution - 377
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Local Institution - 375
Khon Kaen, , Thailand
Holistic Center for Cancer Study and Care
Songkhla, , Thailand
Memorial Ankara Hastanesi
Ankara, Ankara/Cankaya, Turkey (Türkiye)
Gülhane Eğitim ve Araştırma Hastanesi
Ankara, Etlik/Ankara, Turkey (Türkiye)
Medipol Mega Hospital
Istanbul, Samsun, Turkey (Türkiye)
Istanbul Oncology Hospital - Medical Oncology
Istanbul, Samsun, Turkey (Türkiye)
Local Institution - 703
Istanbul, Samsun, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
Ankara, , Turkey (Türkiye)
Ankara Liv Hospital
Ankara, , Turkey (Türkiye)
Ankara City Hospital - Medical Oncology
Ankara, , Turkey (Türkiye)
Trakya Univ Hastanesi Ic Hastal
Edirne, , Turkey (Türkiye)
Goztepe SuleymanYalcin Sehir Hast
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty - Pulmonary
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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January Fields-Meehan, Site 105
Role: primary
Michael Kelley, Site 100
Role: primary
Lawrence Feldman, Site 106
Role: primary
Aknar Freire de Carvalho Calabrich, Site 181
Role: primary
Carlos Henrique Barrios, Site 177
Role: primary
Giuliano Borges, Site 182
Role: primary
Rodrigo Guimarães, Site 178
Role: primary
Helano Freitas, Site 175
Role: primary
Helano Freitas, Site 102
Role: primary
Jasmina Brozic, Site 527
Role: primary
Dragan Trivanovic, Site 529
Role: primary
Denis Moro-Sibilot, Site 559
Role: primary
Remi Veillon, Site 556
Role: primary
Sandrine Hiret, Site 553
Role: primary
Youssef Oulkhouir, Site 554
Role: primary
Elvire Pons-Tostivint, Site 555
Role: primary
Sheik Emambux, Site 557
Role: primary
Jacques Boutros, Site 561
Role: primary
PASCALE TOMASINI, Site 551
Role: primary
LIONEL FALCHERO, Site 560
Role: primary
Regine Lamy, Site 552
Role: primary
Charles Naltet, Site 562
Role: primary
Romain Corre, Site 558
Role: primary
Hugo PICCHI, Site 550
Role: primary
Michalis Liontos, Site 575
Role: primary
Amanda Psyrri, Site 579
Role: primary
Ippokratis Korantzis, Site 580
Role: primary
THEODORA TSIOUDA, Site 576
Role: primary
Eleni Timotheadou, Site 581
Role: primary
Nir Peled, Site 625
Role: primary
Abed Agbaria, Site 629
Role: primary
Elizabeth Dudnik, Site 628
Role: primary
Sameh Daher, Site 627
Role: primary
Ofer Merimsky, Site 626
Role: primary
rita chiari, Site 778
Role: primary
federica biello, Site 777
Role: primary
Vanesa Gregorc, Site 780
Role: primary
Antonio Passaro, Site 779
Role: primary
Giulio Metro, Site 775
Role: primary
Federico Cappuzzo, Site 776
Role: primary
Naoyuki 尚之 Nogami 野上, Site 401
Role: primary
Shigeki 茂樹 Umemura 梅村, Site 402
Role: primary
Site 129
Role: primary
Site 127
Role: primary
Site 125
Role: primary
willemijn Theelen, Site 800
Role: primary
E. (Lisanne) Kastelijn, Site 801
Role: primary
Anghel Adrian Udrea, Site 732
Role: primary
Laura Mazilu, Site 731
Role: primary
Dan Lungulescu, Site 729
Role: primary
Michael Schenker, Site 734
Role: primary
Roxana Scheusan, Site 730
Role: primary
Constantin Volovat, Site 733
Role: primary
Monica Patran, Site 725
Role: primary
Doina Ganea, Site 728
Role: primary
Milan Rancic, Site 754
Role: primary
Marina Petrovic, Site 752
Role: primary
Youngjoo Lee, Site 327
Role: primary
Se-Hoon 세훈 Lee 이, Site 325
Role: primary
Jorge Jose Garcia Gonzalez, Site 680
Role: primary
Alexandra Cantero González, Site 678
Role: primary
Aitor Azkarate, Site 685
Role: primary
Margarita Majem Tarruella, Site 683
Role: primary
ANDRES AGUILAR, Site 687
Role: primary
Nuria Pardo Aranda, Site 681
Role: primary
Antonio Calles Blanco, Site 675
Role: primary
Carlos Aguado de la Rosa, Site 688
Role: primary
David Baz, Site 682
Role: primary
Valentina Gambardella, Site 677
Role: primary
Chien-Hao 建豪 Lai 賴, Site 352
Role: primary
Gee-Chen 基晟 Chang 張, Site 353
Role: primary
Te-Chun 德椿 Hsia 夏, Site 179
Role: primary
Te-Chun 德椿 Hsia 夏, Site 350
Role: primary
Arunee Dechaphunkul, Site 378
Role: primary
Umut Demirci, Site 705
Role: primary
Nuri Karadurmus, Site 702
Role: primary
Ahmet Bilici, Site 709
Role: primary
Engin Erdemoglu, Site 710
Role: primary
Cengiz Karacin, Site 704
Role: primary
Saadettin Kilickap, Site 701
Role: primary
Mehmet Ali Nahit Sendur, Site 706
Role: primary
Muhammet Hacioglu, Site 700
Role: primary
Mahmut Gumus, Site 707
Role: primary
Tuncay Goksel, Site 708
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-503523-25
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0012
Identifier Type: OTHER
Identifier Source: secondary_id
849-021
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0012
Identifier Type: -
Identifier Source: org_study_id
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