Non-Small Cell Lung Cancer (NSCLC)Phase 3NCT05920356
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
A Phase 3 study testing Sotorasib and Pembrolizumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Amgen at 424 sites in 38 countries.
Trial summary
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Sotorasib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 424 sitesin 38 countries
- Study dates
- 16 Nov 2023to 29 Jun 2032
- Phase
- Phase 3
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
- No history of systemic anticancer therapy in metastatic/non-curable settings
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
Who cannot join
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
- Symptomatic (treated or untreated) brain metastases
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
- Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
- Prior therapy with a KRAS G12C inhibitor
Trial locations and contacts
424 sites in 38 countries. Contact the study team or a site near you to ask about taking part.
424 sites in 38 countries
China51 sites, 50 recruiting
- Recruiting
AnYang Tumor Hospital
Anyang, Henan, 455001
- Recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410000
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 611135
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350109
- Recruiting
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080
- Recruiting
Affiliated Cancer Hospital and institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095
- Recruiting
Hainan Cancer Hospital
Haikou, Hainan, 570311
- Recruiting
the First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
- Recruiting
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
- Terminated
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Recruiting
Anhui Chest Hospital
Hefei, Anhui, 230022
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
- Recruiting
Gansu Province Cancer Hospital
Lanzhou, Gansu, 730050
- Recruiting
Linyi Peoples Hospital
Linyi, Shandong, 276002
- Recruiting
Liuzhou Peoples Hospital
Liuzhou, Guangxi, 545006
- Recruiting
The First Affiliated Hospital of Henan University of Science And Technology
Luoyang, Henan, 471003
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210012
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
- Recruiting
Nantong Tumor Hospital
Nantong, Zhejiang, 226361
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
- Recruiting
Weifang Peoples Hospital
Weifang, Shandong, 261071
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
- Recruiting
Tongji Hospital Tongji Medical College Of Hust
Wuhan, Hubei, 430030
- Recruiting
The First Affiliated Hospital of Xi An JiaoTong University
Xi’an, Shanxi, 710065
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
France35 sites, 30 recruiting
- Recruiting
Centre Hospitalier de la Cote Basque
Bayonne, 64100
- Recruiting
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
Besançon, 25030
- Recruiting
Centre Hospitalier Universitaire Ambroise Pare
Boulogne-Billancourt, 92104
- Recruiting
Centre Hospitalier Universitaire de Brest - Hopital Cavale Blanche
Brest, 29609
- Recruiting
Centre Hospitalier Universitaire de Caen - Hopital Cote de Nacre
Caen, 14000
- Recruiting
Centre Hospitalier Metropole Savoie
Chambéry, 73000
- Recruiting
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010
- Recruiting
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925
- Recruiting
Centre Hospitalier - Le Mans
Le Mans, 72000
- Recruiting
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
Lille, 59037
- Recruiting
Hopital Saint Joseph
Marseille, 13285
- Recruiting
Centre Hospitalier Universitaire Nord
Marseille, 13915
- Recruiting
Centre de Cancerologie du Grand Montpellier-Clinique Clementville
Montpellier, 34070
- Recruiting
Hopital prive du Confluent
Nantes, 44277
- Terminated
Centre Antoine Lacassagne
Nice, 06189
- Recruiting
Hopital Universitaire Caremeau
Nîmes, 30029
- Recruiting
Centre Hospitalier Regional d Orleans
Orléans, 45067
- Recruiting
Institut Curie
Paris, 75005
- Recruiting
Groupe Hospitalier Paris Saint Joseph
Paris, 75014
- Terminated
Hopital Cochin
Paris, 75014
- Recruiting
Hopital Tenon
Paris, 75020
- Terminated
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604
- Recruiting
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, 86021
- Terminated
Centre Hospitalier de Cornouaille
Quimper, 29000
- Recruiting
Centre Hospitalier Universitaire de Reims - Hopital Christian Cabrol
Reims, 51092
- Recruiting
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033
- Terminated
Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
Rouen, 76031
- Recruiting
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, 35760
- Recruiting
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270
- Recruiting
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
- Recruiting
Hopital d instruction des armees sainte anne
Toulon, 83800
- Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31059
- Recruiting
Centre Hospitalier Regional Universitaire de Tours - Hopital Bretonneau
Tours, 37044
- Recruiting
Hopital Nord Ouest Villefranche sur Saone
Villefranche-sur-Saône, 69400
- Recruiting
Gustave Roussy
Villejuif, 94805
Japan33 sites, 33 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
- Recruiting
Chiba Cancer Center
Chiba, Chiba, 260-8717
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
- Recruiting
Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
Fukuyama-shi, Hiroshima, 720-0001
- Recruiting
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
- Recruiting
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8563
- Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
- Recruiting
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511
- Recruiting
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, 807-8556
- Recruiting
Kobe Minimally invasive Cancer Center
Kobe, Hyōgo, 650-0046
- Recruiting
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
- Recruiting
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
- Recruiting
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
- Recruiting
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
- Recruiting
Kindai University Hospital
Sakai-shi, Osaka, 590-0197
- Recruiting
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai-shi, Osaka, 591-8555
- Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi, 981-0914
- Recruiting
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293
- Recruiting
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
- Recruiting
Takarazuka City Hospital
Takarazuka-shi, Hyōgo, 665-0827
- Recruiting
Ehime University Hospital
Toon-shi, Ehime, 791-0295
- Recruiting
National Hospital Organization Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, 755-0241
- Recruiting
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
- Recruiting
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
- Recruiting
Tottori University Hospital
Yonago-shi, Tottori, 683-8504
United States30 sites, 26 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
- Recruiting
Messino Cancer Centers Asheville
Asheville, North Carolina, 28806
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
- Recruiting
Boca Raton Clinical Research Coral Springs
Coral Springs, Florida, 33065
- Recruiting
Dayton Physician's Network
Dayton, Ohio, 45415
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Medical University of South Carolina
Florence, South Carolina, 29505
- Recruiting
Oncology Consultants PA
Houston, Texas, 77030
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
US Oncology Research Investigational Products Center
Irving, Texas, 75063
- Recruiting
Mercyhealth
Janesville, Wisconsin, 53548
- Terminated
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, 37920
- Recruiting
Medical University of South Carolina Health Lancaster Medical Center
Lancaster, South Carolina, 29720
- Completed
Norton Cancer Institute - Brownsboro
Louisville, Kentucky, 40241
- Recruiting
Alliance Cancer Specialists - Media
Media, Pennsylvania, 19063
- Recruiting
Regional One Health
Memphis, Tennessee, 38103
- Recruiting
Regis Clinical Research LLC
Miami, Florida, 33126
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203
- Terminated
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713
- Recruiting
Illinois Cancer Specialists
Niles, Illinois, 60714
- Recruiting
Vista Oncology Inc PS
Olympia, Washington, 98506
- Recruiting
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
- Terminated
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Florida Clinical Trials Group Plantation
Plantation, Florida, 33322
- Recruiting
Sansum Clinic
Santa Barbara, California, 93105
- Recruiting
Guthrie Medical Group
Sayre, Pennsylvania, 18840
- Recruiting
Florida Clinical Trials Group Tamarac
Tamarac, Florida, 33321
- Recruiting
Reliant Medical Group Inc
Worcester, Massachusetts, 01606
Brazil24 sites, 12 recruiting
- Recruiting
Fundacao pio xII Barretos
Barretos, São Paulo, 14784-400
- Terminated
Centro de Tratamento Oncologico - Cto
Belém, Pará, 66073-005
- Recruiting
Cenantron Centro Avançado de Tratamento Oncologico Ltda
Belo Horizonte, Minas Gerais, 30130-090
- Terminated
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
Belo Horizonte, Minas Gerais, 30380-472
- Terminated
Hospital Sirio Libanes Brasilia
Brasília, Federal District, 70200-730
- Terminated
Oncoclinicas Onco Vida Distrito Federal
Brasília, Federal District, 70390-150
- Terminated
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, 29308-014
- Terminated
Associação Beneficente de Canoas
Canoas, Rio Grande do Sul, 92030-000
- Terminated
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220
- Recruiting
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59062-000
- Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
- Recruiting
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
- Recruiting
Instituto Medicina Integral Imip
Recife, Pernambuco, 50070-550
- Recruiting
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250-905
- Terminated
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110
- Recruiting
Centro de pesquisa em oncologia Hospital Ana Nery
Santa Cruz do Sul, Rio Grande do Sul, 96835-090
- Terminated
Santa Casa de Misericordia de Santos - Iscms
Santos, São Paulo, 11075-900
- Terminated
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
- Terminated
Beneficencia Portuguesa de Sao Paulo - Bp
São Paulo, São Paulo, 01323-030
- Recruiting
Fundacao Antonio Prudente
São Paulo, São Paulo, 01509-900
- Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, São Paulo, 05652-900
- Terminated
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
São Paulo, 01236-030
- Recruiting
Instituto Cancer Sao Paulo Icesp
São Paulo, 01246-000
Spain22 sites, 17 recruiting
- Terminated
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, 15006
- Recruiting
Hospital Universitario de Badajoz
Badajoz, Extremadura, 06080
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08003
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
- Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
- Recruiting
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908
- Recruiting
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35016
- Recruiting
Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Terminated
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
- Terminated
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
- Terminated
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
- Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid, Castille and León, 47005
- Terminated
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009
Turkey (Türkiye)22 sites, 18 recruiting
- Recruiting
Medical Park Seyhan Hastanesi
Adana, 01140
- Recruiting
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, 01250
- Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230
- Recruiting
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, 06560
- Recruiting
Liv Hospital Ankara
Ankara, 06680
- Recruiting
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
- Recruiting
Akdeniz Universitesi Tip Fakultesi
Antalya, 07050
- Recruiting
Aydin Adnan Menderes Universitesi Tip Fakultesi
Aydin, 09100
- Terminated
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20070
- Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
- Recruiting
Istanbul Bakirkoy Doktor Sadi Konuk Egitim ve Arastirma Hastanesi
Istanbul, 34147
- Terminated
Memorial Bahcelievler Hastanesi
Istanbul, 34180
- Recruiting
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214
- Recruiting
Istinye Universitesi Hastanesi Medical Park Gaziosmanpasa
Istanbul, 34250
- Recruiting
Prof Dr Cemil Tascioglu Sehir Hastanesi
Istanbul, 34384
- Recruiting
Acibadem Maslak Hastanesi
Istanbul, 34457
- Recruiting
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
- Recruiting
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, 34865
- Terminated
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, 34890
- Recruiting
Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35110
- Recruiting
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575
- Terminated
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200
Italy16 sites, 15 recruiting
- Recruiting
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124
- Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
- Recruiting
iNOC Istituto Nazionale Oncologico Candiolo Istituto Ricovero e Cura Carattere Scientifico
Candiolo, 10060
- Recruiting
Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico
Catania, 95123
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
- Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), 47014
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
- Terminated
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB), 20900
- Recruiting
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Naples, 80131
- Recruiting
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Naples, 80138
- Recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
- Recruiting
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156
- Recruiting
Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia
Pesaro, 61122
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
- Recruiting
IRCCS Istituti Fisioterapici Ospitalieri
Rome, 00144
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
Udine, 33100
Greece13 sites, 10 recruiting
- Recruiting
University General Hospital of Alexandroupoli
Alexandroupoli, 68100
- Recruiting
251 General Airforce Hospital
Athens, 11525
- Recruiting
Henry Dunant Hospital Center
Athens, 11526
- Recruiting
Alexandra Hospital
Athens, 11528
- Terminated
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, 12462
- Terminated
Iaso Hospital
Athens, 15123
- Recruiting
Metropolitan Hospital
Athens, 18547
- Terminated
Iaso General Clinic
Marousi, 15123
- Recruiting
University Hospital of Patras
Pátrai, 26504
- Recruiting
Metaxa Anticancer Hospital
Piraeus, 18537
- Recruiting
Theagenion Cancer Hospital
Thessaloniki, 54007
- Recruiting
Agios Loukas Clinic
Thessaloniki, 55236
- Recruiting
European Interbalkan Medical Center
Thessaloniki, 57001
Argentina11 sites, 7 recruiting
- Recruiting
Centro Oncologico Korben
Buenos Aires, 1426
- Terminated
Hospital Britanico de Buenos Aires
CABA, Buenos Aires, C1280AEB
- Recruiting
Instituto Alexander Fleming
Capital Federal, Buenos Aires, C1426ANZ
- Terminated
Instituto Argentino de Diagnostico y Tratamiento IADT
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1012AAR
- Recruiting
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900AUR
- Terminated
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
La Rioja, F5300COE
- Recruiting
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
- Recruiting
Sanatorio Parque SA
Rosario, Santa Fe Province, 2000
- Recruiting
Centro de Diagnostico Investigacion y Tratamiento
Salta, 4400
- Terminated
Fundacion Ars Medica
San Salvador de Jujuy, Jujuy Province, 4600
- Recruiting
Clinica Viedma
Viedma, Río Negro Province, 8500
Australia11 sites, 7 recruiting
- Recruiting
Cancer Research South Australia
Adelaide, South Australia, 5000
- Recruiting
Campbelltown Hospital
Campbelltown, New South Wales, 2560
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
- Recruiting
Nepean Cancer Centre
Kingswood, New South Wales, 2747
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Completed
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
- Completed
GenesisCare -North Shore Oncology
St Leonards, New South Wales, 2065
- Recruiting
Toowoomba Hospital
Toowoomba, Queensland, 4350
- Terminated
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
- Completed
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Poland11 sites, 7 recruiting
- Terminated
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-540
- Recruiting
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, 43-360
- Terminated
Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
Gdynia, 81-519
- Recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Gliwice, 44-102
- Terminated
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
Krakow, 31-826
- Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
- Recruiting
Uniwerystecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-090
- Terminated
Med Polonia Sp zoo
Poznan, 60-693
- Recruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37-700
- Recruiting
Specjalistyczny Szpital im Dra Alfreda Sokolowskiego
Wałbrzych, 58-309
- Recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-781
Colombia9 sites, 7 recruiting
- Recruiting
Centro Cancerologico del Caribe LTDA CECAC
Barranquilla
- Recruiting
Instituto Nacional de Cancerologia
Bogota, Cundinamarca, 111711
- Recruiting
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
Bogotá, Cundinamarca, 110131
- Terminated
Fundacion cardiovascular de Colombia
Bucaramanga, Santander Department, 681017
- Recruiting
Hemato Oncologos SA
Cali, Valle del Cauca Department, 760042
- Recruiting
Fundacion Colombiana de Cancerologia Clinica Vida
Medellín, Antioquia, 050030
- Recruiting
Instituto Medico de Alta Tecnologia sas - Imat sas
Montería, Departamento de Córdoba
- Recruiting
Oncologos del Occidente SAS
Pereira, Risaralda Department, 660001
- Terminated
Sociedad de Oncologia y Hematologia del Cesar
Valledupar, Cesar Department, 200001
Hungary9 sites, 6 recruiting
- Recruiting
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121
- Recruiting
Budapesti Uzsoki Utcai Korhaz
Budapest, 1145
- Recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582
- Recruiting
Matrai Gyogyintezet
Gyöngyös, 3200
- Terminated
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024
- Recruiting
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
- Terminated
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5000
- Terminated
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800
- Recruiting
Reformatus Pulmonologiai Centrum
Törökbálint, 2045
Romania8 sites, 8 recruiting
- Recruiting
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, 022328
- Recruiting
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
- Recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015
- Recruiting
SC Medisprof SRL
Cluj-Napoca, 400641
- Recruiting
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200542
- Recruiting
Institutul Regional de Oncologie Iasi
Iași, 700483
- Recruiting
Spitalul Municipal Ploiesti
Ploieşti, 100337
- Recruiting
SC Oncomed SRL
Timișoara, 300239
South Korea8 sites, 4 recruiting
- Terminated
Pusan National University Hospital
Busan, 49241
- Recruiting
National Cancer Center
Goyang-si Gyeonggi-do, 10408
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Terminated
Korea University Anam Hospital
Seoul, 02841
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Terminated
Korea University Guro Hospital
Seoul, 08308
- Terminated
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongsangnam-do, 50612
United Kingdom8 sites, 6 recruiting
- Terminated
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
- Terminated
Raigmore Hospital
Inverness, IV2 3UJ
- Recruiting
Royal Marsden Hospital
London, SW3 6JJ
- Recruiting
Mount Vernon Cancer Centre
Northwood, HA6 2RN
- Recruiting
Nottingham City Hospital
Nottingham, NG5 1PB
- Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
- Recruiting
Torbay Hospital
Torquay, TQ2 7AA
- Recruiting
Royal Cornwall Hospital
Truro, TR1 3LQ
Austria7 sites, 6 recruiting
- Recruiting
Medizinische Universitaet Graz
Graz, 8036
- Recruiting
Klinikum Klagenfurt am Woerthersee
Klagenfurt, 9020
- Recruiting
Universitaetsklinikum Krems
Krems, 3500
- Recruiting
Klinik Oberwart
Oberwart, 7400
- Completed
Landeskrankenhaus Salzburg
Salzburg, 5020
- Recruiting
Standort Penzing der Klinik Ottakring
Vienna, 1140
- Recruiting
Klinikum Wels - Grieskirchen GmbH
Wels, 4600
Canada7 sites, 4 recruiting
- Recruiting
Queen Elizabeth II, Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
- Recruiting
McGill University Health Centre Glen Site
Montreal, Quebec, H4A 3J1
- Recruiting
CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
- Terminated
Institut Universitaire de cardiologie et de pneumologie de Quebec
Québec, Quebec, G1V 4G5
- Terminated
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
- Terminated
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
- Recruiting
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Chile7 sites, 3 recruiting
- Terminated
Orlandi Oncologia
Santiago, 7500713
- Recruiting
Fundacion Arturo Lopez Perez
Santiago, 7500836
- Recruiting
Biocinetic servicios medicos limitada
Santiago, 8330336
- Terminated
Centro de Investigacion del Maule
Talca, 346000
- Terminated
James Lind Centro de Investigacion del Cancer
Temuco, Cautín, 4800827
- Terminated
Clinica CIDO
Temuco, Cautín, 4810218
- Recruiting
Onco Centro Apys
Viña del Mar, Valparaiso, 2520598
Netherlands7 sites, 6 recruiting
- Recruiting
Meander Medisch Centrum
Amersfoort, 3813 TZ
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
- Terminated
Sint Jansdal Ziekenhuis
Harderwijk, 3844 DG
- Recruiting
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
- Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
- Recruiting
Isala Klinieken
Zwolle, 8025 AB
Taiwan7 sites, 4 recruiting
- Terminated
China Medical University Hospital
Taichung, 40447
- Recruiting
Veterans General Hospital - Taichung
Taichung, 40705
- Terminated
National Cheng Kung University Hospital
Tainan, 70403
- Terminated
Chi Mei Hospital, Liouying
Tainan, 73657
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Thailand7 sites, 4 recruiting
- Recruiting
Vajira Hospital
Bangkok, 10300
- Terminated
King Chulalongkorn Memorial Hospital
Bangkok, 10330
- Recruiting
Phramongkutklao Hospital
Bangkok, 10400
- Recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
- Terminated
Srinagarind Hospital
Khon Kaen, 40002
- Recruiting
Banphaeo General Hospital
Samut Sakhon, 74120
- Terminated
Songklanagarind Hospital
Songkhla, 90110
Belgium6 sites, 4 recruiting
- Completed
Chirec - Delta Ziekenhuis
Auderghem, 1160
- Recruiting
Algemeen Ziekenhuis Maria Middelares
Ghent, 9000
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
- Recruiting
Centre Hospitalier Regional de la Citadelle
Liège, 4000
- Completed
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
Mechelen, 2800
Mexico6 sites, 2 recruiting
- Terminated
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
- Terminated
Actualidad Basada en la Investigación del Cáncer
Guadalajara, 44680
- Terminated
Health Pharma Professional Research SA de CV
Mexico City, Mexico City, 03100
- Terminated
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
- Recruiting
Oncare
Monterrey, Nuevo León, CP66220
- Recruiting
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020
Portugal6 sites, 4 recruiting
- Recruiting
Hospital Cuf Tejo
Lisbon, 1350-352
- Recruiting
Fundacao Champalimaud
Lisbon, 1400-038
- Terminated
Hospital da Luz, SA
Lisbon, 1500-650
- Recruiting
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
Lisbon, 1769-001
- Recruiting
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513
- Terminated
Hospital Cuf porto
Porto, 4100-180
Bulgaria5 sites, 1 recruiting
- Recruiting
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
Panagyurishte, 4500
- Terminated
University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD
Pleven, 5800
- Terminated
Multiprofile Hospital for Active Treatment for Womens Health - Nadezhda OOD
Sofia, 1330
- Terminated
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407
- Terminated
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527
Czechia5 sites, 3 recruiting
- Completed
Fakultni nemocnice Brno
Brno, 625 00
- Recruiting
Masarykuv onkologicky ustav
Brno, 656 53
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
- Completed
Fakultni nemocnice Olomouc
Olomouc, 779 00
- Recruiting
Fakultni nemocnice Plzen
Pilsen, 305 99
Denmark5 sites, 1 recruiting
- Terminated
Aarhus Universitetshospital
Aarhus N, 8200
- Terminated
Rigshospitalet
Copenhagen, 2100
- Recruiting
Regionshospitalet Godstrup
Herning, 7400
- Terminated
Sonderborg Sygehus
Sønderborg, 6400
- Terminated
Vejle Sygehus
Vejle, 7100
Germany5 sites, 3 recruiting
- Recruiting
Klinikum Chemnitz GmbH
Chemnitz, 09113
- Completed
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82130
- Recruiting
Universitaetsmedizin Goettingen
Göttingen, 37075
- Recruiting
Klinikverbund Allgaeu
Kempten, 87439
- Completed
Klinikum der LMU Muenchen
München, 80366
Peru5 sites, 2 recruiting
- Terminated
Centro de Investigacion Vallesur
Arequipa, 04001
- Recruiting
Hospital Nacional Adolfo Guevara Velasco
Cusco, 08003
- Terminated
Oncosalud
Lima, 15036
- Recruiting
Unidad de Investigación Clínica Internacional Sede San Borja
Lima, 15036
- Terminated
Hospital de Apoyo Departamental Maria Auxiliadora
Lima, 15801
Switzerland4 sites, 2 recruiting
- Terminated
Kantonsspital Aarau
Aarau, 5001
- Recruiting
Kantonsspital Baden
Baden, 5404
- Terminated
Universitaetsspital Basel
Basel, 4031
- Recruiting
Universitaetsspital Zuerich
Zurich, 8091
Hong Kong3 sites
- Terminated
Queen Mary Hospital, The University of Hong Kong
Hong Kong
- Terminated
Princess Margaret Hospital
Kowloon
- Terminated
Queen Elizabeth Hospital, Hong Kong
Kowloon
Malaysia3 sites, 3 recruiting
- Recruiting
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 59100
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
- Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100
Sweden3 sites, 1 recruiting
- Terminated
Gavle Sjukhus
Gävle, 801 87
- Terminated
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
- Recruiting
Norrlands Universitetssjukhus
Umeå, 901 85
Latvia2 sites
- Completed
Pauls Stradins Clinical University Hospital
Riga, 1002
- Terminated
Riga East Clinical University Hospital
Riga, 1079
Singapore2 sites, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119228
- Terminated
Tan Tock Seng Hospital
Singapore, 308433
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials
Ponce, 00730
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- Sotorasib, Pembrolizumab
- Keywords
- Oncology, Lung Cancer, PD-L1, KRAS p.G12C, Sotorasib, Pembrolizumab, Carboplatin, Pemetrexed, CodeBreaK 202, NSCLC, PD-L1 Negative, AMG 510, LUMAKRAS ®, LUMYKRAS ®
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotorasibDrug
Also called AMG 510, LUMYKRAS ®, LUMAKRAS ®
Oral administration
PembrolizumabDrug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Sotorasib combined with carboplatin and pemetrexed | Experimental | Sotorasib administered in combination with carboplatin and pemetrexed. Receives: Drug: Sotorasib |
| Pembrolizumab combined with carboplatin and pemetrexed | Active comparator | Pembrolizumab administered in combination with carboplatin and pemetrexed. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
Measured: Approximately 2.5 years
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Measured: Approximately 2.5 years
Secondary outcomes (24)
Objective Response Rate (ORR)
Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.
Measured: From Baseline up to end of study (EOS) (approximately 5.5 years)
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score
Measured: From Baseline to Week 12
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale
Measured: From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Cough Subscale
Measured: From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Chest Pain Subscale
Measured: From Baseline to Week 12
Change in Physical Function as Measured by QLQ-C30
Measured: From Baseline to Week 12
Change in Global Health Status as Measured by QLQ-C30
Measured: From Baseline to Week 12
Progression-free Survival 2 (PFS2)
PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or death from any cause, whichever occurs first.
Measured: From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-LC13 Subscale Scores
Measured: From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-C30 Subscale Scores
Measured: From Baseline up to EOS (approximately 5.5 years)
Time to Deterioration in QLC-LC13 Subscale Scores
Measured: From Baseline to Week 12
Time to Deterioration in QLC-C30 Subscale Scores
Measured: From Baseline to Week 12
Change in Summary Scores and Visual Analogue Scale (VAS) Scores
Measured by EuroQol-5 Dimension (EQ-5D-5L).
Measured: From Baseline up to EOS (approximately 5.5 years)
Duration of Response
Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.
Measured: From Baseline up to EOS (approximately 5.5 years)
Time to Response
Defined as the time from randomization to first evidence of PR or CR per BICR.
Measured: From Baseline up to EOS (approximately 5.5 years)
Disease Control
Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.
Measured: From Baseline up to EOS (approximately 5.5 years)
PFS
Based on investigator tumor assessments per RECIST v1.1.
Measured: From Baseline up to EOS (approximately 5.5 years)
Objective Response
Based on investigator tumor assessments per RECIST v1.1.
Measured: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Treatment-Emergent Adverse Events
Measured: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Vital Signs
Measured: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests
Measured: From Baseline up to EOS (approximately 5.5 years)
Maximum Plasma Concentration (Cmax) of Sotorasib
Measured: Pre-dose Day 1 up to Day 64
Minimum Plasma Concentration (Cmin) of Sotorasib
Measured: Pre-dose Day 1 up to Day 64
Area Under The Curve (AUC) of Sotorasib
Measured: Pre-dose Day 1 up to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start16 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion29 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920356
- Sponsor's protocol ID
- 20190341
- Other IDs
- 2022-501863-41-00
- Status last verified
- Oct 2026
- First submitted
- 23 May 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request