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, 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)
2 other identifiers
interventional
750
37 countries
375
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
375 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2023
CompletedFirst Posted
Study publicly available on registry
June 27, 2023
CompletedStudy Start
First participant enrolled
November 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 29, 2032
May 1, 2026
April 1, 2026
3.6 years
May 23, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
Approximately 2.5 years
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Approximately 2.5 years
Secondary Outcomes (24)
Objective Response Rate (ORR)
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
From Baseline to Week 12
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale
From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Cough Subscale
From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Chest Pain Subscale
From Baseline to Week 12
- +19 more secondary outcomes
Study Arms (2)
Sotorasib combined with carboplatin and pemetrexed
EXPERIMENTALSotorasib administered in combination with carboplatin and pemetrexed.
Pembrolizumab combined with carboplatin and pemetrexed
ACTIVE COMPARATORPembrolizumab administered in combination with carboplatin and pemetrexed.
Interventions
Oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (380)
Sansum Clinic
Santa Barbara, California, 93105, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Norton Cancer Institute - Brownsboro
Louisville, Kentucky, 40241, United States
Reliant Medical Group Inc
Worcester, Massachusetts, 01606, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27710, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374, United States
Alliance Cancer Specialists - Media
Media, Pennsylvania, 19063, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Regional One Health
Memphis, Tennessee, 38103, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203, United States
Oncology Consultants PA
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
US Oncology Research Investigational Products Center
Irving, Texas, 75063, United States
Hospital Britanico de Buenos Aires
CABA, Buenos Aires, C1280AEB, Argentina
Instituto Alexander Fleming
Capital Federal, Buenos Aires, C1426ANZ, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900AUR, Argentina
Fundacion Ars Medica
San Salvador de Jujuy, Jujuy Province, 4600, Argentina
Clinica Viedma
Viedma, Río Negro Province, 8500, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio Parque SA
Rosario, Santa Fe Province, 2000, Argentina
Centro Oncologico Korben
Buenos Aires, 1426, Argentina
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
La Rioja, F5300COE, Argentina
Centro de Diagnostico Investigacion y Tratamiento
Salta, 4400, Argentina
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Cancer Centre
Kingswood, New South Wales, 2747, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
GenesisCare -North Shore Oncology
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298, Australia
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Cancer Research South Australia
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Klinikum Klagenfurt am Woerthersee
Klagenfurt, 9020, Austria
Universitaetsklinikum Krems
Krems, 3500, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Klinikum Wels - Grieskirchen GmbH
Wels, 4600, Austria
Chirec - Delta Ziekenhuis
Auderghem, 1160, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Regional de la Citadelle
Liège, 4000, Belgium
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
Mechelen, 2800, Belgium
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District, 70200-730, Brazil
Oncoclinicas Onco Vida Distrito Federal
Brasília, Federal District, 70390-150, Brazil
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
Belo Horizonte, Minas Gerais, 30380-472, Brazil
Centro de Tratamento Oncologico - Cto
Belém, Pará, 66073-005, Brazil
Instituto Medicina Integral Imip
Recife, Pernambuco, 50070-550, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59062-000, Brazil
Associação Beneficente de Canoas
Canoas, Rio Grande do Sul, 92030-000, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Centro de pesquisa em oncologia Hospital Ana Nery
Santa Cruz do Sul, Rio Grande do Sul, 96835-090, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220, Brazil
Fundacao pio xII Barretos
Barretos, São Paulo, 14784-400, Brazil
Santa Casa de Misericordia de Santos - Iscms
Santos, São Paulo, 11075-900, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Beneficencia Portuguesa de Sao Paulo - Bp
São Paulo, São Paulo, 01323-030, Brazil
Fundacao Antonio Prudente
São Paulo, São Paulo, 01509-900, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250-905, Brazil
Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas
São Paulo, 01236-030, Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, 01246-000, Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
Panagyurishte, 4500, Bulgaria
University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD
Pleven, 5800, Bulgaria
Multiprofile Hospital for Active Treatment for Womens Health - Nadezhda OOD
Sofia, 1330, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
Queen Elizabeth II, Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, H4A 3J1, Canada
CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Institut Universitaire de cardiologie et de pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
James Lind Centro de Investigacion del Cancer
Temuco, Cautín, 4800827, Chile
Clinica CIDO
Temuco, Cautín, 4810218, Chile
Orlandi Oncologia
Santiago, 7500713, Chile
Fundacion Arturo Lopez Perez
Santiago, 7500836, Chile
Biocinetic servicios medicos limitada
Santiago, 8330336, Chile
Centro de Investigacion del Maule
Talca, 346000, Chile
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004, China
Anhui Chest Hospital
Hefei, Anhui, 230022, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350109, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Gansu Province Cancer Hospital
Lanzhou, Gansu, 730050, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
Affiliated Cancer Hospital and institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Liuzhou Peoples Hospital
Liuzhou, Guangxi, 545006, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Hainan Cancer Hospital
Haikou, Hainan, 570311, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
AnYang Tumor Hospital
Anyang, Henan, 455001, China
The First Affiliated Hospital of Henan University of Science And Technology
Luoyang, Henan, 471003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College Of Hust
Wuhan, Hubei, 430030, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
Xiangya Hospital Central South University
Changsha, Hunan, 410000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Linyi Peoples Hospital
Linyi, Shandong, 276002, China
Weifang Peoples Hospital
Weifang, Shandong, 261071, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
The First Affiliated Hospital of Xi An JiaoTong University
Xi’an, Shanxi, 710065, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
West China Hospital Sichuan University
Chengdu, Sichuan, 611135, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
the First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Nantong Tumor Hospital
Nantong, Zhejiang, 226361, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Chest Hospital, Capital Medical University
Beijing, 101149, China
Fundacion Colombiana de Cancerologia Clinica Vida
Medellín, Antioquia, 050030, Colombia
Sociedad de Oncologia y Hematologia del Cesar
Valledupar, Cesar Department, 200001, Colombia
Instituto Nacional de Cancerologia
Bogota, Cundinamarca, 111711, Colombia
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
Bogotá, Cundinamarca, 110131, Colombia
Instituto Medico de Alta Tecnologia sas - Imat sas
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente SAS
Pereira, Risaralda Department, 660001, Colombia
Fundacion cardiovascular de Colombia
Bucaramanga, Santander Department, 681017, Colombia
Centro Cancerologico del Caribe LTDA CECAC
Barranquilla, Colombia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Plzen
Pilsen, 305 99, Czechia
Aarhus Universitetshospital
Aarhus N, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Regionshospitalet Godstrup
Herning, 7400, Denmark
Sonderborg Sygehus
Sønderborg, 6400, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
Besançon, 25030, France
Centre Hospitalier Universitaire Ambroise Pare
Boulogne-Billancourt, 92104, France
Centre Hospitalier Universitaire de Caen - Hopital Cote de Nacre
Caen, 14000, France
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010, France
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925, France
Centre Hospitalier - Le Mans
Le Mans, 72000, France
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
Lille, 59037, France
Centre Hospitalier Universitaire Nord
Marseille, 13915, France
Centre de Cancerologie du Grand Montpellier-Clinique Clementville
Montpellier, 34070, France
Hopital prive du Confluent
Nantes, 44277, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital Universitaire Caremeau
Nîmes, 30029, France
Institut Curie
Paris, 75005, France
Groupe Hospitalier Paris Saint Joseph
Paris, 75014, France
Hopital Cochin
Paris, 75014, France
Hopital Tenon
Paris, 75020, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604, France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, 86021, France
Centre Hospitalier de Cornouaille
Quimper, 29000, France
Centre Hospitalier Universitaire de Reims - Hopital Christian Cabrol
Reims, 51092, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
Rouen, 76031, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091, France
Hopital d instruction des armees sainte anne
Toulon, 83800, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31059, France
Centre Hospitalier Regional Universitaire de Tours - Hopital Bretonneau
Tours, 37044, France
Hopital Nord Ouest Villefranche sur Saone
Villefranche-sur-Saône, 69400, France
Gustave Roussy
Villejuif, 94805, France
Klinikum Chemnitz GmbH
Chemnitz, 09113, Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82130, Germany
Universitaetsmedizin Goettingen
Göttingen, 37075, Germany
Klinikverbund Allgaeu
Kempten, 87439, Germany
Klinikum der LMU Muenchen
München, 80366, Germany
251 General Airforce Hospital
Athens, 11525, Greece
Henry Dunant Hospital Center
Athens, 11526, Greece
Alexandra Hospital
Athens, 11528, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, 12462, Greece
Iaso Hospital
Athens, 15123, Greece
Metropolitan Hospital
Athens, 18547, Greece
Iaso General Clinic
Marousi, 15123, Greece
Metaxa Anticancer Hospital
Piraeus, 18537, Greece
Theagenion Cancer Hospital
Thessaloniki, 54007, Greece
Agios Loukas Clinic
Thessaloniki, 55236, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Kowloon, Hong Kong
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121, Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582, Hungary
Matrai Gyogyintezet
Gyöngyös, 3200, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5000, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, 2045, Hungary
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
Azienda Socio Sanitaria Territoriale Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico
Catania, 95123, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB), 20900, Italy
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Naples, 80138, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156, Italy
Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia
Pesaro, 61122, Italy
IRCCS Istituti Fisioterapici Ospitalieri
Rome, 00144, Italy
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
Udine, 33100, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8563, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Ehime University Hospital
Toon-shi, Ehime, 791-0295, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers
Fukuyama-shi, Hiroshima, 720-0001, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Kobe Minimally invasive Cancer Center
Kobe, Hyōgo, 650-0046, Japan
Takarazuka City Hospital
Takarazuka-shi, Hyōgo, 665-0827, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 981-0914, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Sakai-shi, Osaka, 590-0197, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai-shi, Osaka, 591-8555, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Tottori University Hospital
Yonago-shi, Tottori, 683-8504, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
National Hospital Organization Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, 755-0241, Japan
Pauls Stradins Clinical University Hospital
Riga, 1002, Latvia
Riga East Clinical University Hospital
Riga, 1079, Latvia
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Health Pharma Professional Research SA de CV
Mexico City, Mexico City, 03100, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Oncare
Monterrey, Nuevo León, CP66220, Mexico
Actualidad Basada en la Investigación del Cáncer
Guadalajara, 44680, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Sint Jansdal Ziekenhuis
Harderwijk, 3844 DG, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
Centro de Investigacion Vallesur
Arequipa, 04001, Peru
Hospital Nacional Adolfo Guevara Velasco
Cusco, 08003, Peru
Oncosalud
Lima, 15036, Peru
Unidad de Investigación Clínica Internacional Sede San Borja
Lima, 15036, Peru
Hospital de Apoyo Departamental Maria Auxiliadora
Lima, 15801, Peru
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-540, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, 43-360, Poland
Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
Gdynia, 81-519, Poland
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
Krakow, 31-826, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Uniwerystecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-090, Poland
Med Polonia Sp zoo
Poznan, 60-693, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37-700, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Specjalistyczny Szpital im Dra Alfreda Sokolowskiego
Wałbrzych, 58-309, Poland
Hospital Cuf Tejo
Lisbon, 1350-352, Portugal
Fundacao Champalimaud
Lisbon, 1400-038, Portugal
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
Hospital Cuf porto
Porto, 4100-180, Portugal
Pan American Center for Oncology Trials
Ponce, 00730, Puerto Rico
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, 022328, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
SC Medisprof SRL
Cluj-Napoca, 400641, Romania
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200542, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
SC Oncomed SRL
Timișoara, 300239, Romania
National University Hospital
Singapore, 119228, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Pusan National University Hospital
Busan, 49241, South Korea
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongsangnam-do, 50612, South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, 15006, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Gavle Sjukhus
Gävle, 801 87, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Kantonsspital Aarau
Aarau, 5001, Switzerland
Kantonsspital Baden
Baden, 5404, Switzerland
Universitaetsspital Basel
Basel, 4031, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
Veterans General Hospital - Taichung
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Hospital, Liouying
Tainan, 73657, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305, Taiwan
Vajira Hospital
Bangkok, 10300, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Banphaeo General Hospital
Samut Sakhon, 74120, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Medical Park Seyhan Hastanesi
Adana, 01140, Turkey (Türkiye)
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, 01250, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230, Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, 06560, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, 07050, Turkey (Türkiye)
Aydin Adnan Menderes Universitesi Tip Fakultesi
Aydin, 09100, Turkey (Türkiye)
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20070, Turkey (Türkiye)
Prof Dr Cemil Tascioglu Sehir Hastanesi
Istanbul, 34010, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Memorial Bahcelievler Hastanesi
Istanbul, 34180, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, 34865, Turkey (Türkiye)
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, 34890, Turkey (Türkiye)
Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35110, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55200, Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Raigmore Hospital
Inverness, IV2 3UJ, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LQ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2023
First Posted
June 27, 2023
Study Start
November 16, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 29, 2032
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request