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A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Summary
The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
Official title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
338
Start Date
2024-09-23
Completion Date
2029-11-30
Last Updated
2026-09-16
Healthy Volunteers
No
Interventions
Divarasib
Divarasib will be administered orally QD
Sotorasib
Sotorasib will be administered orally QD
Adagrasib
Adagrasib will be administred orally BID
Locations (151)
Banner Health MD Anderson AZ
Gilbert, Arizona, United States
Los Angeles Cancer Network
Los Angeles, California, United States
UCLA Hematology / Oncology Clinic
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
St. Petersburg, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
New England Cancer Specialists
Westbrook, Maine, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Minnesota Oncology Edina
Edina, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Oncology Associates of Oregon, P.C
Eugene, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC - Chattanooga
Chattanooga, Tennessee, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
JPS Health Network
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - Northeast Texas
Longview, Texas, United States
Hospital Britanico
Buenos Aires, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina
Liverpool Hospital
Liverpool, New South Wales, Australia
GenesisCare North Shore
St Leonards, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Krankenhaus Nord - Klinik Floridsdorf
Vienna, Austria
AZORG Campus Aalst-Moorselbaan
Aalst, Belgium
UZ Brussel
Brussels, Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium
CHU de Liège (Sart Tilman)
Liège, Belgium
CHU UCL Mont-Godinne
Mont-godinne, Belgium
AZ Delta (Campus Rumbeke)
Roeselare, Belgium
Vitaz
Sint-Niklaas, Belgium
ZAS Sint Augustinus Wilrijk
Wilrijk, Belgium
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
William Osler Health Centre - Brampton Civic Hospital
Brampton, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Aarhus Universitetshospital
Aarhus N, Denmark
Herlev Hospital
Herlev, Denmark
Regionshospitalet Gødstrup
Herning, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Kuopio Uni Hospital
Kuopio, Finland
CHRU Brest
Brest, France
Chu Toulouse
Bron, France
Hopital Louis Pradel
Bron, France
CHRU Lille
Lille, France
Centre Leon Berard
Lyon, France
CHU Montpellier
Montpellier, France
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
Nice, France
Hopital Tenon
Paris, France
CHU Bordeaux
Pessac, France
CH de Saint Quentin
Saint-Quentin, France
Chru de Strasbourg
Strasbourg, France
Hia Sainte Anne
Toulon, France
Evangelische Lungenklinik Berlin
Berlin, Germany
Helios Klinikum Emil von Behring GmbH
Berlin, Germany
Klinikum Koeln-Merheim
Cologne, Germany
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
Asklepios Fachkliniken GmbH
Gauting, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
Lungenklinik Hemer
Hemer, Germany
Universität Des Saarlandes
Homburg, Germany
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
Löwenstein, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Klinikum Bogenhausen
München, Germany
Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie
Münster, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Klinikum Würzburg Mitte gGmbH
Würzburg, Germany
Uoa Sotiria Hospital
Athens, Greece
Errikos Dynan Hospital
Athens, Greece
University Hospital of Larissa
Larissa, Greece
Theageneio Hospital
Thessaloniki, Greece
Ag. Loukas Hospital
Thessaloniki, Greece
Tuen Mun Hospital
Hong Kong, Hong Kong
Prince of Wales Hosp
Shatin, Hong Kong
Irccs Ist. Tumori Giovanni Paolo Ii
Bari, Apulia, Italy
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, Italy
IRCCS Istituto Regina Elena (IFO)
Rome, Lazio, Italy
Ospedale Policlinico San Martino
Genoa, Liguria, Italy
Ospedale Civile SS Annunziata
Sassari, Sardinia, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, Italy
Kyushu University Hospital
Fukuoka, Japan