A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Launched by AMGEN · Mar 8, 2024
Trial Information
Current as of June 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called ABP 234 and comparing it to an existing medication known as Keytruda® (pembrolizumab) for patients with advanced non-squamous non-small cell lung cancer (NSCLC). The goal is to see which of the two treatments is more effective in helping patients with this type of cancer. The trial is currently looking for participants aged 18 and older who have been diagnosed with stage IV non-squamous NSCLC and have not received any prior treatment for their advanced disease. To join, patients need to have measurable disease and certain tumor characteristics, and they should not have specific types of lung cancer or active central nervous system issues.
Participants in the trial can expect to receive either ABP 234 or Keytruda® as part of their treatment. Throughout the study, doctors will monitor their health and response to the medication. This trial provides an opportunity for patients who meet the eligibility criteria to access potentially helpful treatments while contributing to important research in lung cancer care. If you or a loved one is interested in participating, it's a good idea to talk to a healthcare provider for more information.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. At least 18 years of age.
- • 2. Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
- • 3. Participant has no prior systemic treatment for advanced disease.
- • 4. Measurable disease according to RECIST v1.1.
- • 5. Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
- • 6. Eastern Cooperative Oncology Group performance status score 0 or 1.
- • 7. Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and c-ros oncogene 1, receptor tyrosine kinase of the insulin receptor family (ROS-1) negative
- • 8. Have a life expectancy of at least 3 months.
- Exclusion Criteria:
- • 1. Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
- • 2. Participant has active central nervous system metastases not previously treated.
- • 3. Participant has active or known immune-mediated disorders.
- • 4. Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
- • 5. Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.
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
Madrid, , Spain
Stony Brook, New York, United States
Taichung, , Taiwan
Hamamatsu, Shizuoka, Japan
Kaohsiung, , Taiwan
Tainan, , Taiwan
Taichung, , Taiwan
Kuching, Sarawak, Malaysia
Riyadh, , Saudi Arabia
Fukuoka Shi, Fukuoka, Japan
Yokosuka, Kanagawa, Japan
Guadalajara, Jalisco, Mexico
Kanagawa, , Japan
Canton, Ohio, United States
Aschaffenburg, , Germany
Kota Bharu, Kelantan, Malaysia
Taipei, , Taiwan
Oviedo, , Spain
Seoul, , Korea, Republic Of
Wytheville, Virginia, United States
Seoul, , Korea, Republic Of
Alcorcon, , Spain
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Iasi, , Romania
Madrid, , Spain
Seoul, , Korea, Republic Of
Seville, , Spain
Seoul, , Korea, Republic Of
Asahikawa, Hokkaido, Japan
Mataro, , Spain
Sremska Kamenica, , Serbia
Matsumoto, Nagano, Japan
Suwon Si, Gyeonggi Do, Korea, Republic Of
Farmington Hills, Michigan, United States
Kuala Lumpur, , Malaysia
Yokohama, Kanagawa, Japan
Fukuoka, Fukuoka Shi, Japan
Rosario, Santa Fe, Argentina
Curitiba, Parana, Brazil
Barretos, Sao Paulo, Brazil
Cheongju Si, Chungcheongbuk Do, Korea, Republic Of
Quezon City, Metro Manila, Philippines
Cluj Napoca, Cluj, Romania
Alor Setar, Kedah, Malaysia
Alicante, , Spain
Timisoara, Timis, Romania
Shibuya Ku, Tokyo, Japan
Passo Fundo, Rio Grande Do Sul, Brazil
Joinville, Santa Catarina, Brazil
Muang, Chiang Rai, Thailand
Lajeado, Rs, Brazil
Bursa, , Turkey
Poznan, , Poland
Muang, Phitsanulok, Thailand
Bangkok, , Thailand
Bursa, , Turkey
Barcelona, , Spain
Amagasaki, Hyogo, Japan
Linz, , Austria
Sevilla, , Spain
Osaki, Miyagi, Japan
Kaohsiung City, , Taiwan
Ankara, , Turkey
Whittier, California, United States
Ankara, , Turkey
Iloilo City, Iloilo, Philippines
Istanbul, , Turkey
Marseille, , France
Konya, , Turkey
Kawasaki Shi, Kanagawa, Japan
Ankara, , Turkey
Los Angeles, California, United States
Varese, , Italy
Tekirdag, , Turkey
Ipatinga, Minas Gerais, Brazil
Mogi Das Cruzes, Sao Paulo, Brazil
Ankara, , Turkey
Ankara, , Turkey
Sofia, , Bulgaria
Tatabanya, , Hungary
Thane, Maharashtra, India
Vantoux, , France
Batumi, , Georgia
Miyazaki Shi, Miyazaki, Japan
Lodz, , Poland
Ankara, , Turkey
Tbilisi, , Georgia
Tbilisi, , Georgia
Ankara, , Turkey
Lublin, , Poland
Tbilisi, , Georgia
Poznan, , Poland
Cerritos, California, United States
Ijui, Rio Grande Do Sul, Brazil
Funabashi Shi, Chiba, Japan
Ankara, , Turkey
Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia
Houston, Texas, United States
Yenimahalle, Ankara, Turkey
Bydgoszcz, Kujawsko Pomorskie, Poland
Ankara, , Turkey
Tamarac, Florida, United States
Ome Shi, Tokyo, Japan
Nagoya, Aichi, Japan
Barcelona, , Spain
Bordeaux, , France
Beverly Hills, California, United States
Salvador, , Brazil
Tbilisi, , Georgia
Valenciennes, , France
Neihu, Taipei, Taiwan
Bordeaux Cedex, , France
Iizuka Shi, Fukuoka, Japan
Plainfield, Illinois, United States
San Antonio, Texas, United States
Providencia, Region Metropolotana, Chile
Belgaum, Karnataka, India
Fukuyama City, Hiroshima, Japan
Lodz, â¿ã³dzkie, Poland
Vina Del Mar, Region De Valparaiso, Chile
Belgrade, , Serbia
Valencia, , Spain
Jaen, , Spain
Jeonju Si, Jeollabuk Do, Korea, Republic Of
Rionero In Vulture, , Italy
Hiroshima City, Hiroshima, Japan
Hat Yai, Songkhla, Thailand
Belo Horizonte, Minas Gerais, Brazil
Asahikawa, Hokkaidâ¿, Japan
Kumamoto City, Kumamoto, Japan
Sakai City,, Osaka Japan, Japan
Hamamatsu City, Shizuoka, Japan
Pensacola, Florida, United States
Sofia, Sofiya Grad, Bulgaria
Szekszard, Tolna, Hungary
Budapest, , Hungary
Matrahaza, , Hungary
Szekesfehervar, , Hungary
Szolnok, , Hungary
Torokbalint, , Hungary
Monserrato, , Italy
Maebashi Shi, Gunma, Japan
Saitama, , Japan
Ploiesti, Prahova, Romania
Timisoara, Timis, Romania
Jud. Iasi, , Romania
Santiago, Region Metropolitana, Chile
Vina Del Mar, Valparaiso, Chile
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Region Metropolitana, Santiago, Chile
Cautin, , Chile
Santiago De Chile, , Chile
Santiago, , Chile
Bayonne, , France
Landshut, , Germany
Ancona, , Italy
Asahikawa City,, Hokkaido, Japan, Japan
Suwon Si, Gyeonggi, Korea, Republic Of
Malaga, , Spain
Sakarya, , Turkey
Leicester, , United Kingdom
Adana, , Turkey
Napoli, , Italy
Bangkoknoi, Bangkok, Thailand
Gaziantep, , Turkey
Sao Paulo, , Brazil
Ravenna, , Italy
Fortaleza, Ceara, Brazil
Cachoeiro De Itapemirim, Espirito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Londrina, Parana, Brazil
Natal, Rio Grande Do Norte, Brazil
Bento Goncalves, Rio Grande Do Sul, Brazil
Porto Alegre Rio Grande Do Sul, Rio Grande Do Sul, Brazil
Porto Alegre, Rs, Brazil
Chapeco, Santa Catarina, Brazil
Florianopolis, Santa Catarina, Brazil
Jardim Blumenau, Santa Catarina, Brazil
Ribeirao Preto, Sao Paulo, Brazil
Canoas, , Brazil
Landshut, , Germany
Kragujevac, , Serbia
Bangkok, , Thailand
Kadikoy, Istanbul, Turkey
Samsun, , Turkey
Ankara, , Turkey
Vitoria, Espirito Santo, Brazil
Pelotas, Rio Grande Do Sul, Brazil
Porto Alegre, , Brazil
Samsun, , Turkey
Houston, Texas, United States
Vina Del Mar, Valparaiso, Chile
Suwon Si, Gyeonggi, Korea, Republic Of
Sao Jose Do Rio Preto, Sao Paulo, Brazil
Hamamatsu City,, Shizuoka, Japan, Japan
Valencia, , Spain
Yenimahalle, Ankara, Turkey
Bangkok, Krung Thep Maha Nakhon, Thailand
Nimes, , France
Toulon, , France
Yenimahalle, Ankara, Turkey
Taipei, Zhongzheng Dist, Taiwan
Muang, Chiang Mai, Thailand
Santo Andre, Sao Paulo, Brazil
Curitiba, , Brazil
Montpellier, , France
Shirley, New York, United States
Limoges, , France
Douliu City, , Taiwan
Iskender, Edirne, Turkey
Salvador, Bahia, Brazil
Pelotas, Rio Grande Do Sul, Brazil
Dobich, Dobrich, Bulgaria
Kaohsiung County, , Taiwan
Campinas, Sp, Brazil
Sao Paulo, , Brazil
Santiago, , Chile
Santiago, , Chile
Los Alamitos, California, United States
Cachoeiro De Itapemirim, Espirito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Vina Del Mar, Valparaiso, Chile
Neumuenster, , Germany
Sondrio, , Italy
Guadalajara, Jalisco, Mexico
Slupsk, , Poland
Chia Yi, , Taiwan
New Taipei City, , Taiwan
Adana, , Turkey
Lima, , Peru
Lima, , Peru
Florianopolis, Santa Catarina, Brazil
Rio De Janeiro, , Brazil
Gaziantep, , Turkey
Davao, Davao Del Sur, Philippines
Dobrich, , Bulgaria
Providencia, Region Metropolitana, Chile
Limoges, , France
Kumamoto, , Japan
Bacolod City, Negros Occidental, Philippines
Valencia, , Spain
Douliu City, , Taiwan
Talat Bang Khen, Lak Si, Thailand
Kecioeren, Ankara, Turkey
Atakum, Samsun, Turkey
Istanbul, , Turkey
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported