RecruitingPhase 2NCT05853575

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

Sponsor

Mirati Therapeutics Inc.

Enrollment

200 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Cancer Advanced Cancer Malignant Neoplasm of Lung

Summary

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different dose schedules of Adagrasib — a targeted drug for a specific type of lung cancer mutation called KRAS G12C — to find out which dosing approach is safer and more effective. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C gene mutation - You have already been treated with platinum-based chemotherapy (like cisplatin or carboplatin) AND an immune checkpoint inhibitor (a type of immunotherapy) - Your prior treatment side effects have resolved **You may NOT be eligible if...** - You have previously been treated with a KRAS G12C inhibitor - Your cancer could potentially be removed by surgery - You have large or untreated brain tumors, or brainstem tumors - You have other serious medical conditions or take medications that could make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdagrasib

KRAS G12C inhibitor

Locations(120)

Samsung Medical Center

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Rambam Health Care Campus

Haifa, Israel

Klinički bolnički centar Sestre milosrdnice

Zagreb, City of Zagreb, Croatia

Local Institution - 101

Santa Rosa, California, 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

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 - HÃ´pital Nord LaÃ"nnec (HGRL) - Service dOncologie medicale â€" Unite dOncologie thoracique

Nantes, Pays de la Loire Region, France

Kansas City VA Hospital

Kansas City, Missouri, United States

Local Institution - 103

Minneapolis, Minnesota, United States

A.C. Camargo Cancer Center

São Paulo, Brazil

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

Local Institution - 650

Krakow, Lesser Poland Voivodeship, Poland

Centre Hosptalier De Villefranche-Sur-Saone - Oncologie Medicale - Cancerolo

Villefranche-sur-Saône, Rhône, France

Centre Hôspitalier de Bretagne Sud - Hôpital du Scorff

Lorient, France

Bnai Zion Medical Center Rheumatology Unit

Haifa, Tel Aviv, Israel

Centre Hospitalier de Cornouaille

Quimper, France

Hôpital Bégin - Service d'Oncologie

Saint-Mandé, France

Local Institution - 577

Pátrai, Achaïa, Greece

Attikon Hospital - 2nd Critical Care

Haidari - Athens, Pella, Greece

St. Luke's Hospital S.A.

Panórama, Greece

Local Institution - 600

Szolnok, Jász-Nagykun-Szolnok, Hungary

Local Institution - 603

Debrecen, Hungary

Theageneio Cancer Hospital

Thessaloniki, Greece

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

General Hospital Of Thessaloniki Papageorgiou

Thessaloniki, Greece

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 - 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

St. Antonius Hospital

Utrecht, Netherlands

Local Institution - 152

San Martín de Porres, Lima region, Peru

Local Institution - 151

Surquillo, Lima region, Peru

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

AP-HM Hopital Nord

Marseille, Rhône, France

GIE Groupe hospitalier Paris Saint-Joseph/Vinci

Paris, France

Shaare Zedek Medical center

Jerusalem, Jerusalem, Israel

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, Italy

General Hospital of Athens "Alexandra"

Athens, Attica, Greece

Local Institution - 328

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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

Local Institution - 751

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

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

Local Institution - 326

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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)

Local Institution - 709

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)

Local Institution - 377

Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand

Local Institution - 726

Bucharest, Romania

Hospital Universitario Virgen de la Macarena - Oncología Médica

Seville, Spain

Hospital Universitari Dexeus Grupo Quironsalud

Barcelona, Spain

Ege University Medical Faculty - Pulmonary

Izmir, Turkey (Türkiye)

Local Institution - 104

Chicago, Illinois, United States

Veterans Affairs Medical Center (VAMC) - Durham - Oncology

Durham, North Carolina, United States

Hospital Clinico Universitario De Valencia - Oncologia Médica y Hematologia

Valencia, Spain

Local Institution - 684

Valencia, Spain

Assuta Medical Center

Tel Aviv, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center - Oncology - Hematology/Oncology

Tel Aviv, Israel

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Local Institution - 679

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

VA North Texas Healthcare System/Dallas VA Medical Center

Dallas, Texas, United States

A.C. Camargo Cancer Center

São Paulo, Brazil

Local Institution - 400

Osaka, Ôsaka [Osaka], Japan

Anthoni van Leeuwenhoek Ziekenhuis, Nederlands Kanker Instit

Amsterdam, North Holland, Netherlands

Local Institution - 582

Athens, Attica, Greece

Hospital Universitario Vall d'Hebron - Oncología Médica

Barcelona, Spain

Local Institution - 689

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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