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
NCT ID: NCT06497556
Last Updated: 2025-11-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
320 participants
INTERVENTIONAL
2024-09-23
2029-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Divarasib
Participants will receive divarasib orally, once daily (QD).
Divarasib
Divarasib will be administered orally QD
KRAS G12C inhibitor
Participants will receive sotorasib orally QD or adagrasib orally twice a day (BID)
Sotorasib
Sotorasib will be administered orally QD
Adagrasib
Adagrasib will be administred orally BID
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Divarasib
Divarasib will be administered orally QD
Sotorasib
Sotorasib will be administered orally QD
Adagrasib
Adagrasib will be administred orally BID
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Documentation of the presence of a KRAS G12C mutation
* Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of \>= 12 weeks
Exclusion Criteria
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Known concomitant second oncogenic driver
* Mixed small-cell lung cancer or large cell neuroendocrine histology
* Known and untreated, or active central nervous system (CNS) metastases
* Leptomeningeal disease or carcinomatous meningitis
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
* Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
* Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
* More than 30 Gy of radiotherapy to the lung within 6 months of randomization
* Uncontrolled tumor-related pain
* Unresolved toxicities from prior anticancer therapy
* History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner Health MD Anderson AZ
Gilbert, Arizona, United States
Banner Health MD Anderson AZ
Phoenix, Arizona, United States
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
Los Angeles Cancer Network
Los Angeles, California, United States
UCLA Hematology / Oncology Clinic
Los Angeles, California, United States
Community Clinical Trials
Orange, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
UC Health Oncology Research
Colorado Springs, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Bay Pines Foundation Inc
Bay Pines, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Florida Cancer Specialists.
St. Petersburg, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Summit Cancer Care PC
Savannah, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, United States
Mission Cancer + Blood - IMMC
Waukee, Iowa, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Norton Cancer Institute- Poplar
Louisville, Kentucky, United States
VA Shreveport Healthcare System
Shreveport, Louisiana, United States
New England Cancer Specialists
Westbrook, Maine, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana Farber/Harvard Cancer Center (Foxborough)
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institute
Methuen, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System;Clinical Trials Office
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Minnesota Oncology Edina
Edina, Minnesota, United States
Nebraska Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Renown Regional Medical Center Hospital
Reno, Nevada, United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, United States
New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York, New York, United States
Mount SInai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, United States
New York Cancer & Blood Specialists
The Bronx, New York, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Firsthealth of The Carolinas
Pinehurst, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
SCRI Mark H. Zangmeister Center
Columbus, Ohio, 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
Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 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
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, United States
Hospital Britanico
Buenos Aires, , Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, , Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, , Argentina
Sanatorio Parque S.A.
Rosario, , Argentina
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
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
Klinik Penzing
Vienna, , Austria
Institut für Lungenforschung Wien
Vienna, , Austria
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 Brasilia
Brasília, Federal District, Brazil
Clinica Onconeo
Campo Grande, Mato Grosso do Sul, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 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
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, , Brazil
William Osler Health Centre - Brampton Civic Hospital
Brampton, Ontario, Canada
Princess Margaret Cancer Center
Toronto, 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
Turku Uni Central Hospital
Turku, , Finland
CHU Angers
Angers, , France
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
Charité Universitätsmedizin Berlin, Med Klinik Infekto und Pneumo
Berlin, , Germany
Helios Klinikum Emil von Behring GmbH
Berlin, , Germany
Klinikum Braunschweig
Braunschweig, , 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
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Lungenklinik Hemer
Hemer, , Germany
Universität Des Saarlandes
Homburg, , Germany
Lungenfachklinik Immenhausen
Immenhausen, , Germany
Uniklinik Schleswig-Holstein
Kiel, , Germany
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
Löwenstein, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Universität Mannheim
Mannheim, , Germany
Klinikum Bogenhausen
München, , Germany
Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie
Münster, , Germany
Pius Hospital Oldenburg
Oldenburg, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Klinikum Würzburg Mitte gGmbH
Würzburg, , Germany
Uoa Sotiria Hospital
Athens, , Greece
Errikos Dynan Hospital
Athens, , Greece
Metropolitan Hospital Fourth Oncology Clinic
Faliro, , Greece
University Hospital of Larissa
Larissa, , Greece
Theageneio Hospital
Thessaloniki, , Greece
Ag. Loukas Hospital
Thessaloniki, , Greece
Hong Kong Integrated Oncology Centre
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Tuen Mun Hospital
Hong Kong, , Hong Kong
Prince of Wales Hosp
Shatin, , Hong Kong
Irccs Ist. Tumori Giovanni Paolo Ii
Bari, Apulia, Italy
Az. Osp. Pugliese Ciaccio
Catanzaro, Calabria, Italy
AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna, Italy
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, Italy
AUSL della Romagna
Ravenna, Emilia-Romagna, Italy
Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, Italy
IRCCS Istituto Regina Elena (IFO)
Rome, Lazio, Italy
Ospedale Policlinico San Martino
Genoa, Liguria, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
IRCCS Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
A.O.U. Maggiore della Carità
Novara, Piedmont, Italy
Ospedale Civile SS Annunziata
Sassari, Sardinia, Italy
AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello
Palermo, Sicily, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padua, Veneto, Italy
Shikoku Cancer Center
Ehime, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Sendai Kousei Hospital
Miyagi, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Kindai University Hospital
Osaka, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Centro de Infusion E Investigacion Oncologia de Saltillo Sc
Saltillo, Coahuila, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Clínica Integral Internacional de Oncología S de RL de CV
Puebla City, Puebla, Mexico
PanAmerican Clinical Research, Querétaro
Querétaro City, Querétaro, Mexico
ARKE Estudios Clínicos S.A. de C.V.
Mexico City, , Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Ziekenhuis Rijnstate
Arnhem, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Ziekenhuis St. Jansdal
Harderwijk, , Netherlands
Medisch Centrum Haaglanden, locatie Antoniushove
Leidschendam, , Netherlands
Isala
Zwolle, , Netherlands
Instytut "Centrum Zdrowia Matki Polki"
?ód?, , Poland
Kujawsko-Pomorskie Centrum Pulmonologii
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, , Poland
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Krakow, , Poland
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, , Poland
Radomskie Centrum Onkologii
Radom, , Poland
Instytut Gruzlicy I Chorob Pluc
Warsaw, , Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
Warsaw, , Poland
Dolno?L?Skie Centrum Onkologii, Pulmonologii I Hematologii
Wroc?aw, , Poland
Hospital de Braga
Braga, , Portugal
CHUC - Unidade de Pneumologia Oncológica
Coimbra, , Portugal
Centro Clinico Champalimaud
Lisbon, , Portugal
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, , Portugal
IPO do Porto
Porto, , Portugal
National Cancer Centre
Singapore, , Singapore
Curie Oncology (Farrer)
Singapore, , Singapore
Pusan National University Hospital
Busan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
St. Vincent's Hospital
Gyeonggi-do, , South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Institut Catala d Oncologia Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Nuestra Senora de Valme
Seville, Sevilla, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Vall Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Gävle Sjukhus
Gävle, , Sweden
Hsin-Chu Branch of National Taiwan University Hospital
Hsinchu, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Vajira Hospital
Bangkok, , Thailand
Siriraj Hospital - Chulabhorn Bone Marrow Transplant Centre
Bangkok, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Velindre NHS Trust - Velindre Cancer Centre
Cardiff, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Guy's Hospital - Cancer Centre
London, , United Kingdom
Royal Marsden Hospital - London
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: BO45217 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-510908-37-00
Identifier Type: OTHER
Identifier Source: secondary_id
BO45217
Identifier Type: -
Identifier Source: org_study_id