AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3Krascendo 2NCT06793215

A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

A Phase 3 study testing Divarasib, Pembrolizumab and Pemetrexed in people with Non-Small Cell Lung Cancer and KRAS G12C Lung Cancer, run by Hoffmann-La Roche at 299 sites in 28 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Divarasib, Pembrolizumab and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
299 sitesin 28 countries
Study dates
24 Oct 2025to 31 Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • Measurable disease, as defined by RECIST v1.1
  • No prior systemic treatment for advanced or metastatic NSCLC
  • Documentation of the presence of a KRAS G12C mutation
  • Documentation of known PD-L1 expression status in tumor tissue
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  • Availability of a representative tumor specimen
  • Adequate end-organ function
  • Eligible to receive a platinum-based chemotherapy regimen

Who cannot join

  • Known concomitant second oncogenic driver with available targeted treatment
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization
  • History of leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
Show all 17Show fewer
  • Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
  • Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung >30Gy within 6 months prior to randomization
  • Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
  • Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
  • Current treatment with medications that are well known to prolong the QT interval
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
  • Prior allogeneic stem cell or solid organ transplantation
  • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate >90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
  • Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
  • Significant cardiovascular disease within 3 months prior to screening

Trial locations and contacts

299 sites in 28 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CO45042 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

299 sites in 28 countries

United States69 sites, 68 recruiting

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508

    Recruiting

  • Ascension Network - St Elizabeth's Hospital

    Appleton, Wisconsin, 54915

    Recruiting

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318

    Recruiting

  • Saint Agnes Hospital - Baltimore - Hunt - PPDS

    Baltimore, Maryland, 21229-5201

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

    Recruiting

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

    Recruiting

  • St. Luke's Cancer Institute

    Boise, Idaho, 83712

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Affiliated Oncologists, LLC

    Chicago Ridge, Illinois, 60415

    Recruiting

  • Community Cancer Institute (CCI)

    Clovis, California, 93611

    Recruiting

  • UC Health Oncology Research

    Colorado Springs, Colorado, 80909

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8575

    Recruiting

  • Mission Cancer + Blood - IMMC

    Des Moines, Iowa, 50309

    Recruiting

  • AsteraCancer Care

    East Brunswick, New Jersey, 08816

    Recruiting

  • Renovatio Clinical - El Paso

    El Paso, Texas, 79915

    Recruiting

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

    Recruiting

  • Profound Research, LLC

    Farmington Hills, Michigan, 48334

    Recruiting

  • Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System

    Fort Collins, Colorado, 80528

    Recruiting

  • Florida Cancer Specialists - SOUTH - SCRI - PPDS

    Fort Myers, Florida, 33901-8108

    Recruiting

  • JPS Health Network

    Fort Worth, Texas, 76104

    Recruiting

  • University of Florida Health at Shands

    Gainesville, Florida, 32610

    Recruiting

  • City of Hope - Phoenix

    Goodyear, Arizona, 85338

    Recruiting

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505

    Recruiting

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

    Recruiting

  • Gibbs Cancer Center & Research Institute

    Greer, South Carolina, 29650

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

    Recruiting

  • BioResearch Partner

    Hialeah, Florida, 33013

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

    Withdrawn

  • Memorial Healthcare System - Memorial Regional Hospital

    Hollywood, Florida, 33021

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4000

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • UCI Health-CIACC

    Irvine, California, 92612

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Recruiting

  • Community Clinical Trials

    Kingwood, Texas, 77339

    Recruiting

  • NHO Revive Research Institute

    Lincoln, Nebraska, 68506

    Recruiting

  • UCLA Oncology Center

    Los Angeles, California, 90024

    Recruiting

  • Texas Tech Health Science Center

    Lubbock, Texas, 79415

    Recruiting

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Recruiting

  • Ascension Columbia St. Mary's

    Milwaukee, Wisconsin, 53211

    Recruiting

  • City of Hope® Atlanta

    Newnan, Georgia, 30265

    Recruiting

  • Hoag Memorial Hospital

    Newport Beach, California, 92658

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • University of California Irvine

    Orange, California, 92868

    Recruiting

  • Advent Health Orlando

    Orlando, Florida, 32804

    Recruiting

  • Palo Alto Medical Foundation Research Center

    Palo Alto, California, 94301

    Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

    Recruiting

  • Firsthealth of The Carolinas

    Pinehurst, North Carolina, 28374

    Recruiting

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • WakeMed

    Raleigh, North Carolina, 27610

    Recruiting

  • Cancer Care Specialists

    Reno, Nevada, 89511

    Recruiting

  • Sutter Institute for Medical Research

    Roseville, California, 95661

    Recruiting

  • Metro-Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

    Recruiting

  • California Pacific Medical Center

    San Francisco, California, 94115

    Recruiting

  • Summit Cancer Care PC

    Savannah, Georgia, 31405

    Recruiting

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Recruiting

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    St. Petersburg, Florida, 33701

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Recruiting

  • Montefiore Einstein Cancer Center

    The Bronx, New York, 10461

    Recruiting

  • Renovatio Clinical

    The Woodlands, Texas, 77380

    Recruiting

  • University of Texas Health Center at Tyler

    Tyler, Texas, 75708

    Recruiting

  • Florida Cancer Specialists - EAST - SCRI - PPDS

    West Palm Beach, Florida, 33401-3406

    Recruiting

  • Reading Hospital - McGlinn Cancer Institute

    West Reading, Pennsylvania, 19611

    Recruiting

  • Clinical Research Alliance

    Westbury, New York, 11590

    Recruiting

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

    Recruiting

  • City of Hope® Cancer Center Chicago

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

Germany26 sites, 26 recruiting

  • Vivantes - Klinikum Im Friedrichshain;Innere Medizin ? Hämatologie, Onkologie und Palliativmedizin

    Berlin, 10249

    Recruiting

  • Charite - Universitätsmedizin Berlin

    Berlin, 13353

    Recruiting

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165

    Recruiting

  • Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus;Medizinische Klinik und Poliklinik I

    Dresden, 01307

    Recruiting

  • KEM/Evang. Kliniken Essen Mitte gGmbH

    Essen, 45136

    Recruiting

  • Universitätsklinikum Essen

    Essen, 45147

    Recruiting

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

    Recruiting

  • Asklepios Fachkliniken GmbH

    Gauting, 82131

    Recruiting

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

    Recruiting

  • Christliches Klinikum Halle (Saale) GmbH, Standort Dölau

    Halle, 06120

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Asklepios Klinik Harburg

    Hamburg, 21075

    Recruiting

  • KRH Klinikum Siloah-Oststadt-Heidehaus

    Hanover, 30459

    Recruiting

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

    Recruiting

  • Universität Des Saarlandes

    Homburg, 66421

    Recruiting

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

    Recruiting

  • ViDia Christliche Kliniken Karlsruhe;Medizinische Klinik 2, Studienzentrale Prof. MzB. / Raum G.018

    Karlsruhe, 76137

    Recruiting

  • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein

    Löwenstein, 74245

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

    Recruiting

  • Universität Mannheim

    Mannheim, 68167

    Recruiting

  • Klinikum Bogenhausen

    München, 81925

    Recruiting

  • Universitaetsklinikum Muenster

    Münster, 48149

    Recruiting

  • Pius Hospital Oldenburg

    Oldenburg, 26121

    Recruiting

  • Universitätsklinikum Regensburg

    Regensburg, 93053

    Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Recruiting

  • Klinikum Würzburg Mitte gGmbH

    Würzburg, 97074

    Recruiting

Other trials in Germany

Japan20 sites, 20 recruiting

  • Fujita Health University Hospital

    Aichi, 470-1192

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Recruiting

  • Kurume University Hospital

    Fukuoka, 830-0011

    Recruiting

  • Hakodate Goryoukaku Hospital

    Hokkaido, 040-8611

    Recruiting

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

    Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520

    Recruiting

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

    Recruiting

  • Sendai Kousei Hospital

    Miyagi, 981-0914

    Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

    Recruiting

  • Kansai Medical University Hospital

    Osaka, 573-1191

    Recruiting

  • Kindai University Hospital

    Osaka, 590-0197

    Recruiting

  • Tohoku University Hospital

    Sendai, 980-8574

    Recruiting

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045

    Recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

    Recruiting

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

    Recruiting

Other trials in Japan

China19 sites, 19 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • the First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233000

    Recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Recruiting

  • The second Xiangya hospital of central south university

    Changsha, 410100

    Recruiting

  • West China Hospital - Sichuan University

    Chengdu, 611130

    Recruiting

  • The First Affilicated Hospital, Sun Yat-sen University

    Guangzhou

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Recruiting

  • Anhui Provincial Hospital(The First Affiliated Hospital of USTC)

    Hefei, Anhui, 230036

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Recruiting

  • Yunnan Cancer Hospital

    Kunming

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330209

    Recruiting

  • Nantong Tumor Hospital

    Nantong, 226361

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Recruiting

  • Shanghai East Hospital

    Shanghai, 200120

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

    Recruiting

  • Tumor Hospital of the affiliated medical college of Shantou University

    Shantou, 515000

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Recruiting

Other trials in China

Italy16 sites, 16 recruiting

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli Venezia Giulia, 33081

    Recruiting

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)

    Genoa, Liguria, 16132

    Recruiting

  • USL 6 Toscana Nord Ovest ? P.O. Livorno

    Livorno, Tuscany, 57124

    Recruiting

  • IEO Istituto Europeo di Oncologia

    Milan, Lombardy, 20141

    Recruiting

  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    Milan, Lombardy, 20162

    Recruiting

  • Humanitas Centro Catanese Di Oncologia

    Misterbianco (CT), Sicily, 95045

    Recruiting

  • A.O. Universitaria Policlinico Di Modena

    Modena, Emilia-Romagna, 41100

    Recruiting

  • Azienda Ospedaliera San Gerardo di Monza

    Monza MI, Lombardy, 20900

    Recruiting

  • AORN Ospedali dei Colli Ospedale Monaldi

    Naples, Campania, 80131

    Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

    Recruiting

  • Presidio san salvatore muraglia

    Pesaro, Emilia-Romagna, 61122

    Recruiting

  • Ospedale P. Pederzoli Casa di cura Privata

    Peschiera Del Garda (VR), Veneto, 37019

    Recruiting

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00151

    Recruiting

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168

    Recruiting

  • Ospedale Giuseppe Moscati

    Statte, Apulia, 74010

    Recruiting

  • Ospedale di Trento-Presidio Ospedaliero Santa Chiara

    Trento, Trentino-Alto Adige, 38122

    Recruiting

Other trials in Italy

Spain15 sites, 15 recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Recruiting

  • ICO L'Hospitalet

    Barcelona, 08908

    Recruiting

  • Complejo Hospitalario Universitario Insular?Materno Infantil

    Las Palmas de Gran Canaria, LAS Palmas, 35016

    Recruiting

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027

    Recruiting

  • Hospital Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

    Recruiting

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

    Recruiting

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

France14 sites, 14 recruiting

  • CHU Angers

    Angers, 49933

    Recruiting

  • Hopital Avicenne

    Bobigny, 93009

    Recruiting

  • Hôpital Louis Pradel, Hospices Civils de Lyon

    Bron, 69677

    Recruiting

  • Centre Francois Baclesse

    Caen, 14076

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • CHU Montpellier

    Montpellier, 34295

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Recruiting

  • Groupe Hospitalier Paris Saint Joseph

    Paris, 75014

    Recruiting

  • Hopital Tenon

    Paris, 75970

    Recruiting

  • CHU Bordeaux

    Pessac, 33604

    Recruiting

  • Centre Hospitalier Universitaire de Reims

    Reims, 51092

    Recruiting

  • CH de Saint Quentin

    Saint-Quentin, 02321

    Recruiting

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091

    Recruiting

  • Centre Hospitalier Bretagne Atlantique Vannes

    Vannes, 56017

    Recruiting

Other trials in France

United Kingdom12 sites, 12 recruiting

  • Blackpool Teaching Hospitals NHS Foundation Trust , Victoria Hospital

    Blackpool, FY3 8NR

    Recruiting

  • Bristol Haematology & Oncology Centre

    Bristol, BS2 8ED

    Recruiting

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, CT1 3NG

    Recruiting

  • Velindre NHS Trust - Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ

    Recruiting

  • Barts and the London NHS Trust

    London, E1 2ES

    Recruiting

  • Royal Marsden Hospital - Fulham

    London, SW3 6JJ

    Recruiting

  • Sarah Cannon Research Institute

    London, W1G 6AD

    Recruiting

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone, ME16 9QQ

    Recruiting

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE

    Recruiting

  • University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

    Recruiting

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Poland10 sites, 10 recruiting

  • Centrum Pulmonologii i Torakochirurgii

    Bystra, 43-360

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

    Recruiting

  • Krakowski Szpital Specjalistyczny im sw.Jana Pawla II

    Krakow, 31-202

    Recruiting

  • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

    Recruiting

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357

    Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569

    Recruiting

  • Radomskie Centrum Onkologii

    Radom, 26-600

    Recruiting

  • Instytut Gruzlicy I Chorob Pluc

    Warsaw, 01-138

    Recruiting

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, 05-135

    Recruiting

  • Dolnoslaskie Centrum Chorob Pluc

    Wroclaw, 53-439

    Recruiting

Other trials in Poland

Canada9 sites, 9 recruiting

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

    Recruiting

  • William Osler Health Centre - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

    Recruiting

  • BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

    Kelowna, British Columbia, V1Y 5L3

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • CHU de Quebec - Hopital de l'Enfant-Jesus

    Québec, G1J 1Z4

    Recruiting

  • Centre Hospitalier Regional De Rimouski

    Rimouski, Quebec, G5L 5T1

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Recruiting

  • BC Cancer - Victoria

    Victoria, British Columbia, V8R 6V5

    Recruiting

Other trials in Canada

Australia8 sites, 7 recruiting

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

    Recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Recruiting

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Withdrawn

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

    Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Belgium8 sites, 7 recruiting

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300

    Recruiting

  • UZ Brussel

    Brussels, 1090

    Recruiting

  • Cliniques Universitaires St-Luc

    Brussels, 1200

    Withdrawn

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

    Recruiting

  • UZ Leuven Gasthuisberg

    Leuven, 3000

    Recruiting

  • CHU de Liège (Sart Tilman)

    Liège, 4000

    Recruiting

  • CHU HELORA - Hôpital de Mons - Site Kennedy

    Mons, 7000

    Recruiting

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Brazil7 sites, 7 recruiting

  • Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

    Recruiting

  • Centro Integrado de Oncologia de Curitiba

    Curitiba, Paraná, 80810-050

    Recruiting

  • Crio - Centro Regional Integrado de Oncologia

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About this study

Official title: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Being tested
Divarasib, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin
Keywords
Advanced Non-Small Cell Lung Cancer, KRAS G12 Lung Cancer, Advanced Lung Cancer, Metastatic lung cancer, Divarasib, KRAS G12C Inhibitor, KRAS G12C Positive, KRAS Mutation, KRAS G12C Mutation, Lung Cancer Mutation
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DivarasibDrug

    Divarasib will be administered orally QD

  • PembrolizumabDrug

    Pembrolizumab will be administered via IV infusion Q3W

  • PemetrexedDrug

    Pemetrexed will be administered via IV infusion Q3W

  • CarboplatinDrug

    Carboplatin will be administered via IV infusion Q3W

  • CisplatinDrug

    Cisplatin will be administered via IV infusion Q3W

Study groups in NCT06793215
Study groupRoleWhat they receive
Divarasib + PembrolizumabExperimentalParticipants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W)
Receives: Drug: Divarasib; Drug: Pembrolizumab
Pembrolizumab + Pemetrexed + Carboplatin or CisplatinActive comparatorParticipants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W
Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)

    Measured: Up to approximately 5 years

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause

    Measured: Up to approximately 5 years

Secondary outcomes (9)

  1. Objective Response

    Objective response is defined as complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by BICR according to RECIST v1.1

    Measured: Up to approximately 5 years

  2. Change from Baseline on the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (EORTC QLQ-LC13) Cough Scale

    Measured: Baseline up to Cycle 5 Day 1 (each cycle is 21 days)

  3. Change from Baseline on the EORTC Quality of Life Questionnaire (QLQ-C30) Dyspnea Item and Physical Functioning Scale

    Measured: Baseline up to Cycle 5 Day 1 (each cycle is 21 days)

  4. Duration of Response (DOR)

    DOR is defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)

    Measured: Up to approximately 5 years

  5. Percentage of Participants with Adverse Events (AEs)

    Measured: Up to approximately 5 years

  6. Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Measured: Up to approximately 5 years

  7. Change from Baseline in the Severity of Selected Symptomatic Treatment Toxicities as Assessed Through use of the NCI PRO-CTCAE

    Measured: Up to approximately 5 years

  8. Frequency of Participants' Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the single-item EORTC Item List (IL46)

    Measured: Up to approximately 5 years

  9. Change from Baseline on the EORTC QLQ-C30 and QLQ-LC13 Functional and Global Health Status Score/Quality of Life Score (GHS/QoL)

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start24 Oct 2025
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06793215
Sponsor's protocol ID
CO45042
Acronym
Krascendo 2
Status last verified
Nov 2026
First submitted
20 Jan 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Divarasib, Pembrolizumab and Pemetrexed in people with Non-Small Cell Lung Cancer and KRAS G12C Lung Cancer, run by Hoffmann-La Roche at 299 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 299 sites in United States, Germany, Japan, China, Italy and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: CO45042 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06793215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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