Spots Global Cancer Trial Database for Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
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Trial Identification
Brief Title: Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
Official Title: A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
Study ID: NCT05853575
Interventions
Study Description
Brief 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.
Detailed Description: 849-021 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Providence Medical Foundation, Santa Rosa, California, United States
Durham VA Medical Center, Durham, North Carolina, United States
VA North Texas Healthcare System/Dallas VA Medical Center, Dallas, Texas, United States
Centre Hospitalier de Bretagne Sud - Hopital du Scorff, Lorient, , France
APHM Hopital Nord, Marseille, , France
Hopital Haut-Leveque-Maladies Respiratoires, Pessac, , France
National Cancer Center, Goyang-si, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hopital Universitario Virgen De La Macarena, Sevilla, , Spain
China Medical University Hospital - Internal Medicine, Taichung City, , Taiwan
Ankara Liv Hospital Tibbi Onkoloji, Ankara, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Gulhane Egitim ve Arastirma Hastanesi tibbi Onkoloji Klinigi, Ankara, , Turkey
Memorial Ankara Hastanesi Tibbi Onkoloji, Ankara, , Turkey
Trakya Universitesi Hastanesi Ic Hastaliklari Anabilim Dali Tibbi Onkoloji, Edirne, , Turkey
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Tibbi Onkoloji, Istanbul, , Turkey
Istanbul Onkoloji Hastanesi Tibbi Onkoloji, Istanbul, , Turkey
Contact Details
Name: Julie Meade, MD
Affiliation: Mirati Therapeutics
Role: STUDY_DIRECTOR
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