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ACTIVE NOT RECRUITING
NCT06497556
PHASE3

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

View on ClinicalTrials.gov

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

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

Divarasib

Divarasib will be administered orally QD

DRUG

Sotorasib

Sotorasib will be administered orally QD

DRUG

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

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