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A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Sponsor: Mirati Therapeutics Inc.
Summary
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Official title: A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
630
Start Date
2025-04-24
Completion Date
2032-04-30
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Adagrasib
Specified dose on specified days
Pembrolizumab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Placebo
Specified dose on specified days
Cisplatin
Specified dose on specified days
Locations (317)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Local Institution - 0682
Loma Linda, California, United States
Helios Clinical Research
Long Beach, California, United States
National Jewish Health Medical Center
Denver, Colorado, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Morton Plant Hospital - BayCare Health System
Clearwater, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Local Institution - 0696
Miami, Florida, United States
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Florida Clinical Trials Group.
Plantation, Florida, United States
St. Anthony's Hospital
St. Petersburg, Florida, United States
Florida Clinical Trials Group.
Tamarac, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Springfield Clinic Main Campus
Springfield, Illinois, United States
Northwest Cancer Centers, P.C.
Dyer, Indiana, United States
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Mercy Medical Center
Cedar Rapids, Iowa, United States
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, United States
The University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States
Owensboro Medical Health System
Owensboro, Kentucky, United States
Mercy Health-Paducah Medical Oncology and Hematology
Paducah, Kentucky, United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States
Velocity Clinical Research, Annapolis
Annapolis, Maryland, United States
Maryland Oncology Hematology - Columbia
Columbia, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
SSM Health Cancer Care - Fenton
Fenton, Missouri, United States
Local Institution - 0678
Cooperstown, New York, United States
Ellis Hospital
Schenectady, New York, United States
White Plains Hospital
White Plains, New York, United States
WellSpan Oncology Research
York, Pennsylvania, United States
St Francis Cancer Center
Greenville, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Local Institution - 0697
Nashville, Tennessee, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
University Of Texas Medical Branch At Galveston
Galveston, Texas, United States
Oncology & Hematology of South Texas
Laredo, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
Clinica Adventista Belgrano
CABA, Buenos Aires F.D., Argentina
Sanatorio Plaza
Rosario, Santa Fe Province, Argentina
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Tamworth Hospital
North Tamworth, New South Wales, Australia
Orange Hospital
Orange, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Frankston Hospital
Frankston, Victoria, Australia
Northern Hospital
Melbourne, Victoria, Australia
Latrobe Regional Health
Traralgon, Victoria, Australia
Joondalup Health Campus
Joondalup, Western Australia, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria
Kepler Universitätsklinikum
Linz, Austria
Medizinische Universität Wien
Vienna, Austria
Klinik Floridsdorf
Vienna, Austria
UZ Brussel
Brussels, Bruxelles-Capitale, Région de, Belgium
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium
Jessa Ziekenhuis
Hasselt, Limburg, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
CEDOES
Vitória, Espírito Santo, Brazil
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
Cetus Oncologia - Unidade Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Hospital de Amor Amazônia
Porto Velho, Rondônia, Brazil
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, Brazil
Clínica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Advanze Pesquisa
São Carlos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
A. C. Camargo Cancer Center
São Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil
MBAL Uni Hospital
Panagyurishte, Pazardzhik, Bulgaria
Local Institution - 0628
Sofia, Sofia (stolitsa), Bulgaria
Complex Oncology Center - Ruse EOOD
Rousse, Bulgaria
Trakia Hospital
Stara Zagora, Bulgaria
St. Marys Hospital Center
Montreal, Quebec, Canada
Bradfordhill
Recoleta, Santiago Metropolitan, Chile
FALP
Santiago, Santiago Metropolitan, Chile
The First Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China