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: 2026-01-20
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
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ACTIVE_NOT_RECRUITING
PHASE3
338 participants
INTERVENTIONAL
2024-09-23
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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Divarasib
Divarasib will be administered orally QD
Sotorasib
Sotorasib will be administered orally QD
Adagrasib
Adagrasib will be administred orally BID
Eligibility Criteria
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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
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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)
Padua, Veneto, Italy
Kyushu University Hospital
Fukuoka, , Japan
Sendai Kousei Hospital
Miyagi, , Japan
Kindai University Hospital
Osaka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
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
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, , Poland
Instytut Gruzlicy I Chorob Pluc
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
St. Vincent's Hospital
Gyeonggi-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
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
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 Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Gävle Sjukhus
Gävle, , Sweden
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
Songklanagarind Hospital
Songkhla, , Thailand
Addenbrooke's Hospital
Cambridge, , 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
Nottingham City Hospital
Nottingham, , United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
Countries
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Other Identifiers
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2024-510908-37-00
Identifier Type: OTHER
Identifier Source: secondary_id
BO45217
Identifier Type: -
Identifier Source: org_study_id
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