Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
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)
Study ID: NCT05920356
Conditions
Study Description
Brief Summary: The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Illinois at Chicago, Chicago, Illinois, United States
Norton Cancer Institute - Brownsboro, Louisville, Kentucky, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center Knoxville, Knoxville, Tennessee, United States
Hospital Britanico de Buenos Aires, Caba, Buenos Aires, Argentina
Instituto Alexander Fleming, Capital Federal, Buenos Aires, Argentina
Instituto Argentino de Diagnostico y Tratamiento IADT, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundacion Ars Medica, San Salvador de Jujuy, Jujuy, Argentina
Clinica Viedma, Viedma, Río Negro, Argentina
Sanatorio Parque SA, Rosario, Santa Fe, Argentina
Centro Oncologico Korben, Buenos Aires, , Argentina
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer, La Rioja, , Argentina
Centro de Diagnostico Investigacion y Tratamiento, Salta, , Argentina
Campbelltown Hospital, Campbelltown, New South Wales, Australia
Concord Repatriation General Hospital, Concord, New South Wales, Australia
GenesisCare -North Shore Oncology, St Leonards, New South Wales, Australia
Toowoomba Hospital, Toowoomba, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Cancer Research South Australia, Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Medizinische Universitaet Graz, Graz, , Austria
Klinikum Klagenfurt am Woerthersee, Klagenfurt, , Austria
Universitaetsklinikum Krems, Krems, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Chirec - Delta Ziekenhuis, Auderghem, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Regional de la Citadelle, Liège, , Belgium
Algemeen Ziekenhuis Sint-Maarten, Mechelen, , Belgium
Instituto de Medicina Integral Professor Fernando Figueira, Recife, Pernambuco, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre, Rio Grande Do Sul, Brazil
Centro de pesquisa em oncologia Hospital Ana Nery, Santa Cruz do Sul, Rio Grande Do Sul, Brazil
Catarina Pesquisa Clinica, Itajaí, Santa Catarina, Brazil
Beneficencia Portuguesa de Sao Paulo, Sao Paulo, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp, São Paulo, , Brazil
Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagyurishte, , Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD, Sofia, , Bulgaria
Queen Elizabeth II, Health Sciences Centre, Halifax, Nova Scotia, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
McGill University Health Centre Glen Site, Montreal, Quebec, Canada
CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal, Montreal, Quebec, Canada
Institut Universitaire de cardiologie et de pneumologie de Quebec, Quebec City, Quebec, Canada
James Lind Centro de Investigacion del Cancer, Temuco, Cautín, Chile
Clinica CIDO, Temuco, Cautín, Chile
Orlandi Oncologia, Santiago, , Chile
Fundacion Arturo Lopez Perez, Santiago, , Chile
Biocinetic, Santiago, , Chile
Centro de Investigacion del Maule, Talca, , Chile
Guangdong Provincial Peoples Hospital, Guangzhou, Guangdong, China
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Plzen, Plzen, , Czechia
Aarhus Universitetshospital, Aarhus N, , Denmark
Regionshospitalet Godstrup, Herning, , Denmark
Rigshospitalet, Kobenhavn, , Denmark
Sonderborg Sygehus, Sonderborg, , Denmark
Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz, Besancon cedex, , France
Centre Hospitalier Universitaire Ambroise Pare, Boulogne-Billancourt, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
Centre Hospitalier - Le Mans, Le Mans, , France
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon, Lille Cedex, , France
Centre Hospitalier Universitaire Nord, Marseille Cedex 20, , France
Centre de Cancerologie du Grand Montpellier-Clinique Clementville, Montpellier, , France
Hopital Universitaire Caremeau, Nimes cedex 9, , France
Hôpital Tenon, Paris Cedex 20, , France
Institut Curie, Paris, , France
Groupe Hospitalier Paris Saint Joseph, Paris, , France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque, Pessac Cedex, , France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie, Poitiers Cedex, , France
Centre Hospitalier de Cornouaille, Quimper, , France
Centre Hospitalier Universitaire de Reims - Hôpital Maison blanche, Reims Cedex, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou, Rennes, , France
Hopital d instruction des armees sainte anne, Toulon, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey, Toulouse Cedex 9, , France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau, Tours Cedex 9, , France
Hopital Nord-Ouest Villefranche, Villefranche Sur Saone Cedex, , France
Gustave Roussy, Villejuif, , France
Klinikum Chemnitz GmbH, Chemnitz, , Germany
Universitaetsmedizin Goettingen, Goettingen, , Germany
Klinikverbund Allgaeu, Kempten, , Germany
Klinikum der LMU Muenchen, Muenchen, , Germany
251 General Airforce Hospital, Athens, , Greece
Henry Dunant Hospital Center, Athens, , Greece
Alexandra Hospital, Athens, , Greece
Attikon University Hospital, Athens, , Greece
Metropolitan Hospital, Athens, , Greece
Iaso General Clinic, Marousi, , Greece
Theagenion Cancer Hospital, Thessaloniki, , Greece
Agios Loukas Clinic, Thessaloniki, , Greece
European Interbalkan Medical Center, Thessaloniki, , Greece
University of Hong Kong, Queen Mary Hospital, Hong Kong, , Hong Kong
Orszagos Koranyi Pulmonologiai Intezet, Budapest, , Hungary
Farkasgyepui Tudogyogyintezet, Farkasgyepu, , Hungary
Matrai Gyogyintezet, Gyongyos, , Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz, Szekesfehervar, , Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz, Tatabanya, , Hungary
Reformatus Pulmonologiai Centrum, Torokbalint, , Hungary
IRCCS Istituto Tumori Giovanni Paolo II, Bari, , Italy
Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico, Catania, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola (FC), , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza (MB), , Italy
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi, Napoli, , Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia, Perugia, , Italy
Nagoya University Hospital, Nagoya-shi, Aichi, Japan
Hirosaki University Hospital, Hirosaki-shi, Aomori, Japan
Chiba Cancer Center, Chiba-shi, Chiba, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan
Ehime University Hospital, Toon-shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health Japan, Kitakyushu-shi, Fukuoka, Japan
Kurume University Hospital, Kurume-shi, Fukuoka, Japan
Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers, Fukuyama-shi, Hiroshima, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo-shi, Hokkaido, Japan
Kobe Minimally invasive Cancer Center, Kobe-shi, Hyogo, Japan
Takarazuka City Hospital, Takarazuka-shi, Hyogo, Japan
Kanazawa University Hospital, Kanazawa-shi, Ishikawa, Japan
St Marianna University Hospital, Kawasaki-shi, Kanagawa, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
Kyoto University Hospital, Kyoto-shi, Kyoto, Japan
Miyagi Cancer Center, Natori-shi, Miyagi, Japan
Sendai Kousei Hospital, Sendai-shi, Miyagi, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
Okayama University Hospital, Okayama-shi, Okayama, Japan
Kansai Medical University Hospital, Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute, Osaka-shi, Osaka, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
National Hospital Organization Kinki-chuo Chest Medical Center, Sakai-shi, Osaka, Japan
Saitama Cancer Center, Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan
Tottori University Hospital, Yonago-shi, Tottori, Japan
Wakayama Medical University Hospital, Wakayama-shi, Wakayama, Japan
National Hospital Organization Yamaguchi-Ube Medical Center, Ube-shi, Yamaguchi, Japan
National Cancer Center, Goyang-si Gyeonggi-do, , Korea, Republic of
Gachon University Gil Hospital, Incheon, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Pauls Stradins Clinical University Hospital, Riga, , Latvia
Riga East Clinical University Hospital, Riga, , Latvia
Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia
Pantai Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia
University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia
Actualidad Basada en la Investigación del Cáncer, Guadalajara, , Mexico
Meander Medisch Centrum, Amersfoort, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Sint Jansdal Ziekenhuis, Harderwijk, , Netherlands
Maastricht Universitair Medisch Centrum, Maastricht, , Netherlands
Elisabeth-TweeSteden Ziekenhuis, Tilburg, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, , Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej, Bystra, , Poland
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo, Krakow, , Poland
Uniwerystecki Szpital Kliniczny Nr 4 w Lublinie, Lublin, , Poland
Med Polonia Sp zoo, Poznan, , Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu, Przemysl, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warszawa, , Poland
Fundacao Champalimaud, Lisboa, , Portugal
Hospital da Luz, SA, Lisboa, , Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente, Lisboa, , Portugal
Hospital Cuf Tejo, Lisboa, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano, Matosinhos, , Portugal
Hospital Cuf porto, Porto, , Portugal
Institutul Oncologic, Prof Dr Alexandru Trestioreanu, Bucuresti, , Romania
Spitalul Universitar de Urgenta Bucuresti, Bucuresti, , Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj Napoca, , Romania
SC Medisprof SRL, Cluj Napoca, , Romania
Centrul de Oncologie Sf Nectarie SRL, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Spitalul Municipal Ploiesti, Ploiesti, , Romania
SC Oncomed SRL, Timisoara, , Romania
Tan Tock Seng Hospital, Singapore, , Singapore
Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, Aragón, Spain
Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Canarias, Spain
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital del Mar, Barcelona, Cataluña, Spain
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals, Hospitalet de Llobregat, Cataluña, Spain
Hospital Clinico Universitario de Valencia, Valencia, Comunidad Valenciana, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Sahlgrenska Universitetssjukhuset, Goteborg, , Sweden
Gavle Sjukhus, Gävle, , Sweden
Kantonsspital Aarau, Aarau, , Switzerland
Kantonsspital Baden, Baden, , Switzerland
Universitaetsspital Basel, Basel, , Switzerland
Veterans General Hospital - Taichung, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Phramongkutklao Hospital, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, , Thailand
Srinagarind Hospital, Khon Kaen, , Thailand
Songklanagarind Hospital, Songkla, , Thailand
Medical Park Seyhan Hastanesi, Adana, , Turkey
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara, , Turkey
Ankara Bilkent Sehir Hastanesi, Ankara, , Turkey
Akdeniz Universitesi Tip Fakultesi, Antalya, , Turkey
Pamukkale Universitesi Tip Fakultesi Hastanesi, Denizli, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul, , Turkey
Bagcilar Medipol Mega Universite Hastanesi, Istanbul, , Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
Izmir Ekonomi Universitesi Medical Point Hastanesi, Izmir, , Turkey
Raigmore Hospital, Inverness, , United Kingdom
Torbay Hospital, Torquay, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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