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)
Launched by AMGEN · Jun 26, 2023
Trial Information
Current as of May 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called CodeBreaK 202, is studying two different treatments for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation known as KRAS p. G12C. The trial aims to compare how long patients can live without their cancer getting worse (this is known as progression-free survival) when they receive either sotorasib combined with standard chemotherapy or pembrolizumab combined with standard chemotherapy.
To participate, patients need to be diagnosed with advanced stage IV or stage IIIB/C nonsquamous NSCLC and have the KRAS mutation, but not a specific protein called PD-L1. They should not have had previous cancer treatments for their advanced cancer and should be in relatively good health. If eligible, participants will receive one of the two treatment combinations and will be closely monitored throughout the study. This trial is currently looking for patients aged between 18 and 100, regardless of gender, to help determine which treatment may be more effective for this type of lung cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
- • 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
About Amgen
Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
New York, New York, United States
Nice, , France
Copenhagen, , Denmark
Saskatoon, Saskatchewan, Canada
Regina, Saskatchewan, Canada
Chicago, Illinois, United States
Madrid, , Spain
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Concord, New South Wales, Australia
Vejle, , Denmark
Durham, North Carolina, United States
Singapore, , Singapore
Nottingham, , United Kingdom
Houston, Texas, United States
Barcelona, , Spain
Toowoomba, Queensland, Australia
Sonderborg, , Denmark
Madrid, , Spain
Melbourne, Victoria, Australia
Woolloongabba, Queensland, Australia
Birmingham, , United Kingdom
Sutton, , United Kingdom
Khon Kaen, , Thailand
Taipei, , Taiwan
Santander, Cantabria, Spain
Groningen, , Netherlands
London, , United Kingdom
Paris, , France
Taipei, , Taiwan
Chengdu, Sichuan, China
Madrid, , Spain
Villejuif, , France
Campbelltown, New South Wales, Australia
Taichung, , Taiwan
Quimper, , France
Seoul, , Korea, Republic Of
Worcester, Massachusetts, United States
Albuquerque, New Mexico, United States
Athens, , Greece
Tainan, , Taiwan
Paris, , France
Lodz, , Poland
Bangkok, , Thailand
Yonago Shi, Tottori, Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Melbourne, Victoria, Australia
Aarau, , Switzerland
Natori Shi, Miyagi, Japan
Niigata Shi, Niigata, Japan
Sunto Gun, Shizuoka, Japan
Umea, , Sweden
Bunkyo Ku, Tokyo, Japan
Lublin, , Poland
Inverness, , United Kingdom
Bangkok, , Thailand
Beijing, , China
Barcelona, Cataluña, Spain
Hong Kong, , Hong Kong
Ploiesti, , Romania
La Roche Sur Yon, , France
Northwood, , United Kingdom
Graz, , Austria
Chicago, Illinois, United States
Gent, , Belgium
Torokbalint, , Hungary
Kuantan, Pahang, Malaysia
Salzburg, , Austria
Hangzhou, Zhejiang, China
Truro, , United Kingdom
Nanjing, Jiangsu, China
Zhengzhou, Henan, China
Bucuresti, , Romania
Fuzhou, Fujian, China
Xiamen, Fujian, China
Brno, , Czechia
Taipei, , Taiwan
Baden, , Switzerland
Milano, , Italy
Goettingen, , Germany
Firenze, , Italy
Zwolle, , Netherlands
Waratah, New South Wales, Australia
Wels, , Austria
Chiang Mai, , Thailand
Songkla, , Thailand
Istanbul, , Turkey
Changsha, Hunan, China
Goteborg, , Sweden
Basel, , Switzerland
Majadahonda, Madrid, Spain
Singapore, , Singapore
Kurume Shi, Fukuoka, Japan
Changchun, Jilin, China
Seoul, , Korea, Republic Of
Athens, , Greece
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Quebec City, Quebec, Canada
Firenze, , Italy
Salvador, Bahia, Brazil
Maastricht, , Netherlands
Ube Shi, Yamaguchi, Japan
Kunming, Yunnan, China
Changchun, , China
Zuerich, , Switzerland
Aarhus N, , Denmark
Milano, , Italy
Kowloon, , Hong Kong
Toon Shi, Ehime, Japan
Seoul, , Korea, Republic Of
Guadalajara, Jalisco, Mexico
Torquay, , United Kingdom
Shanghai, Shanghai, China
Riga, , Latvia
Paris, , France
Bari, , Italy
Parma, , Italy
Recife, Pernambuco, Brazil
Iasi, , Romania
Créteil, , France
Nanchang, Jiangxi, China
Amersfoort, , Netherlands
Monterrey, Nuevo León, Mexico
Hong Kong, , Hong Kong
Zhengzhou, Henan, China
Busan, , Korea, Republic Of
Chengdu, Sichuan, China
Beijing, Beijing, China
Beijing, , China
Taiyuan, Shanxi, China
Creteil, , France
Xiamen, Fujian, China
Okayama Shi, Okayama, Japan
Wuhan, , China
Incheon, , Korea, Republic Of
Wuhan, Hubei, China
Porto, , Portugal
Fukuoka Shi, Fukuoka, Japan
Kanazawa Shi, Ishikawa, Japan
Olomouc, , Czechia
Athens, , Greece
Harbin, Heilongjiang, China
Santiago, , Chile
Fuzhou, , China
Luoyang, Henan, China
Knoxville, Tennessee, United States
Pittsburgh, Pennsylvania, United States
Liège, , Belgium
Tainan, , Taiwan
Nagoya Shi, Aichi, Japan
Warszawa, , Poland
Barcelona, Cataluña, Spain
Itajai, Santa Catarina, Brazil
Denizli, , Turkey
Chiba Shi, Chiba, Japan
Sendai Shi, Miyagi, Japan
Athens, , Greece
Changsha, Hunan, China
Athens, , Greece
Matsuyama Shi, Ehime, Japan
Cluj Napoca, , Romania
Taoyuan, , Taiwan
Nanchang, Jiangxi, China
Xiangyang, Hubei, China
Kashiwa Shi, Chiba, Japan
Koto Ku, Tokyo, Japan
Barcelona, Cataluña, Spain
Lisboa, , Portugal
Budapest, , Hungary
Plzen, , Czechia
Valencia, Comunidad Valenciana, Spain
Harderwijk, , Netherlands
Sevilla, Andalucía, Spain
Valencia, Comunidad Valenciana, Spain
Bangkok, , Thailand
Chengdu, , China
Sofia, , Bulgaria
Shantou, Guangdong, China
Osaka Shi, Osaka, Japan
Sapporo Shi, Hokkaido, Japan
Brasilia, Distrito Federal, Brazil
Hirakata Shi, Osaka, Japan
Nanjing, Jiangsu, China
Las Palmas De Gran Canaria, Canarias, Spain
Poitiers Cedex, , France
Perugia, , Italy
Timisoara, , Romania
Pessac Cedex, , France
Montreal, Quebec, Canada
Kitaadachi Gun, Saitama, Japan
Leuven, , Belgium
Riga, , Latvia
Wakayama Shi, Wakayama, Japan
Itajaí, Santa Catarina, Brazil
Medellin, Antioquia, Colombia
Thessaloniki, , Greece
Lima, , Peru
Matosinhos, , Portugal
Ankara, , Turkey
Rennes, , France
Guangzhou, Guangdong, China
Louisville, Kentucky, United States
Chongqing, Chongqing, China
Barcelona, Cataluña, Spain
Takarazuka Shi, Hyogo, Japan
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Krems, , Austria
Porto Alegre, Rio Grande Do Sul, Brazil
Thessaloniki, , Greece
Kawasaki Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Goyang Si Gyeonggi Do, , Korea, Republic Of
Lisboa, , Portugal
Bucuresti, , Romania
Cluj Napoca, , Romania
Yangsan Si, Gyeongsangnam Do, , Korea, Republic Of
Baoding, Hebei, China
Guangzhou, Guangdong, China
Toulouse Cedex 9, , France
Porto Alegre, Rio Grande Do Sul, Brazil
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Osakasayama Shi, Osaka, Japan
Bucaramanga, Santander, Colombia
Istanbul, , Turkey
Tilburg, , Netherlands
Klagenfurt, , Austria
Temuco, Cautín, Chile
Santiago, , Chile
Lisboa, , Portugal
Zaragoza, Aragón, Spain
Hefei, Anhui, China
Adelaide, South Australia, Australia
Kobenhavn, , Denmark
Kyoto Shi, Kyoto, Japan
Sakai Shi, Osaka, Japan
Birmingham, , United Kingdom
Taizhou, , China
Kingswood, New South Wales, Australia
Lanzhou, Gansu, China
Nanning, Guangxi, China
Marseille Cedex 20, , France
Strasbourg Cedex, , France
Napoli, , Italy
Fukuyama Shi, Hiroshima, Japan
Taichung, , Taiwan
Viedma, Río Negro, Argentina
Taizhou, Zhejiang, China
Istanbul, , Turkey
Panagyurishte, , Bulgaria
Sofia, , Bulgaria
Toronto, Ontario, Canada
Temuco, Cautín, Chile
Przemysl, , Poland
Malaga, Andalucía, Spain
Buenos Aires, , Argentina
Kempten, , Germany
Mechelen, , Belgium
San Salvador De Jujuy, Jujuy, Argentina
Mexico City, Distrito Federal, Mexico
Hirosaki Shi, Aomori, Japan
Thessaloniki, , Greece
Meldola (Fc), , Italy
Kitakyushu Shi, Fukuoka, Japan
Bialystok, , Poland
Barretos, São Paulo, Brazil
Paris Cedex 20, , France
Besancon, , France
Valledupar, Cesar, Colombia
Salta, , Argentina
Sao Paulo, São Paulo, Brazil
Monza (Mb), , Italy
Anyang, Henan, China
Ankara, , Turkey
Izmir, , Turkey
Besancon Cedex, , France
Rio De Janeiro, , Brazil
Sao Jose Do Rio Preto, São Paulo, Brazil
Farkasgyepu, , Hungary
Capital Federal, Buenos Aires, Argentina
Gyor, , Hungary
Gdynia, , Poland
Tatabanya, , Hungary
Ankara, , Turkey
Szekesfehervar, , Hungary
Craiova, , Romania
Nantes Cedex 2, , France
St Leonards, New South Wales, Australia
Herning, , Denmark
Hospitalet De Llobregat, Cataluña, Spain
Toulon, , France
Pinehurst, North Carolina, United States
Incheon, , Korea, Republic Of
Santa Cruz Do Sul, Rio Grande Do Sul, Brazil
Budapest, , Hungary
Gyongyos, , Hungary
Istanbul, , Turkey
Samsun, , Turkey
Rosario, Santa Fe, Argentina
Kobe Shi, Hyogo, Japan
Bystra, , Poland
Krakow, , Poland
Poznan, , Poland
Gävle, , Sweden
Marousi, , Greece
Caba, Buenos Aires, Argentina
Halifax, Nova Scotia, Canada
Boulogne Billancourt, , France
Montpellier, , France
Reims Cedex, , France
Santiago, , Chile
São Paulo, , Brazil
Lille Cedex, , France
Cachoeiro De Itapemirim, Espírito Santo, Brazil
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
La Rioja, , Argentina
Auderghem, , Belgium
Le Mans, , France
Tours Cedex 9, , France
Villefranche Sur Saone Cedex, , France
Bystra, , Poland
Gauting, , Germany
Chemnitz, , Germany
Nimes Cedex 9, , France
Athens, , Greece
Torokbalint, , Hungary
Halifax, Nova Scotia, Canada
Talca, , Chile
Catania, , Italy
Lisboa, , Portugal
Lisboa, , Portugal
Adana, , Turkey
Montreal, Quebec, Canada
Lublin, , Poland
Guadalajara, , Mexico
Sendai Shi, Miyagi, Japan
Muenchen, , Germany
Antalya, , Turkey
Sao Paulo, São Paulo, Brazil
Paris Cedex 20, , France
Rouen Cedex, , France
Napoli, , Italy
Monterrey, Nuevo León, Mexico
A Coruña, Galicia, Spain
Sao Paulo, São Paulo, Brazil
La Plata, Buenos Aires, Argentina
Belem, Pará, Brazil
Recife, Pernambuco, Brazil
Santos, São Paulo, Brazil
São Paulo, , Brazil
Liuzhou, Guangxi, China
Nanning, Guangxi, China
Linyi, Shandong, China
Nantong, Zhejiang, China
Bengbu, Anhui, China
Jinan, Shandong, China
Pleven, , Bulgaria
Fuzhou, Fujian, China
Haikou, Hainan, China
Weifang, Shandong, China
Bogotá, Cundinamarca, Colombia
Saint Priest En Jarez, , France
Hong Kong, , Hong Kong
Reims Cedex, , France
Caen, , France
Aydin, , Turkey
Istanbul, , Turkey
Belo Horizonte, Minas Gerais, Brazil
Monteria, Córdoba, Colombia
Xi'an, Shanxi, China
Barranquilla, , Colombia
Canoas, Rio Grande Do Sul, Brazil
Natal, Rio Grande Do Norte, Brazil
Bogota, Cundinamarca, Colombia
Arequipa, , Peru
Lima, , Peru
Pereira, Risaralda, Colombia
Walbrzych, , Poland
Lima, , Peru
Caen, , France
Saint Priest En Jarez, , France
Tours Cedex 9, , France
Villefranche Sur Saone Cedex, , France
Monteria, Córdoba, Colombia
Brasilia, Distrito Federal, Brazil
Samut Sakhon, , Thailand
Bucaramanga, Santander, Colombia
Sofia, , Bulgaria
Kowloon, , Hong Kong
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported