A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
- Conditions
- Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06311721
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 927
- At least 18 years of age.
- Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
- Participant has no prior systemic treatment for advanced disease.
- Measurable disease according to RECIST v1.1.
- Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
- Eastern Cooperative Oncology Group performance status score 0 or 1.
- 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
- Have a life expectancy of at least 3 months.
- Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
- Participant has active central nervous system metastases not previously treated.
- Participant has active or known immune-mediated disorders.
- Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab (US) Pembrolizumab (US) Part 1: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed. ABP 234 ABP 234 Part 1: Participants will receive ABP 234 followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive ABP 234 followed by pemetrexed. Pembrolizumab (EU) Pembrolizumab (EU) Part 1: Participants will receive EU-approved pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive EU-approved pembrolizumab followed by pemetrexed.
- Primary Outcome Measures
Name Time Method Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 21 days Objective response (OR) Week 49 OR defined as an overall response of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234 Week 16 through Week 19
- Secondary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234 Week 16 through Week 19 Cmax_ss of pembrolizumab (US) Week 16 through Week 19 Cmax_ss of of pembrolizumab (EU) Week 16 through Week 19 Number of participants who experience a Treatment-emergent adverse event Up to 2.5 years Number of participants who experience a Treatment-emergent serious adverse event Up to 2.5 years Number of participants who experience a Treatment-emergent adverse event of interest Up to 2.5 years Tmax_ss of pembrolizumab (EU) Week 16 through Week 19 OR Week 31 Duration of response (DOR) Up to 2.5 years Overall survival (OS) Up to 2.5 years Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234 Day 1 up to Week 107 Time to maximum concentration following the first dose (tmax_dose1) of ABP 234 Day 1 up to Week 107 Tmax_dose1 of pembrolizumab (US) Day 1 up to Week 107 Tmax_dose1 of pembrolizumab (EU) Day 1 up to Week 107 Tmax_ss of pembrolizumab (US) Week 16 through Week 19 Ctrough_w4 of pembrolizumab (US) Week 4 Ctrough_w4 of pembrolizumab (EU) Week 4 Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234 Week 16 through Week 19 Time to maximum concentration at steady state (tmax_ss) of ABP 234 Week 16 through Week 19 Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234 Week 4 AUC21d of pembrolizumab (US) 21 days AUC21d of pembrolizumab (EU) 21 days Number of participants who experience anti-drug antibodies (ADA) Up to 2.5 years Ctrough_ss at pre-dose of pembrolizumab (US) Week 16 through Week 19 Ctrough_ss at pre-dose of pembrolizumab (EU) Week 16 through Week 19 AUCtau_ss of pembrolizumab (US) Week 16 through Week 19 AUCtau_ss pembrolizumab (EU) Week 16 through Week 19 Progression-free survival (PFS) Up to 2.5 years Cmax_dose1 of pembrolizumab (US) Day 1 up to Week 107 Cmax_dose1 of pembrolizumab (EU) Day 1 up to Week 107
Trial Locations
- Locations (170)
Gazi University Faculty of Medicine
🇹🇷Yenimahalle, Ankara, Turkey
Precision NextGen Oncology and Research Center
🇺🇸Beverly Hills, California, United States
TOI Clinical Research
🇺🇸Cerritos, California, United States
Cancer and Blood Specialty Clinic (CBSC)
🇺🇸Los Alamitos, California, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
PIH Health Hospital
🇺🇸Whittier, California, United States
BRCR Medical Center Inc.
🇺🇸Tamarac, Florida, United States
Accellacare Duly
🇺🇸Plainfield, Illinois, United States
Detroit Clinical Research Center, PC
🇺🇸Farmington Hills, Michigan, United States
North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists
🇺🇸Shirley, New York, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Millennium Research and Clinical Development, LLC
🇺🇸Houston, Texas, United States
Texas Oncology, P.A
🇺🇸San Antonio, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
🇺🇸Wytheville, Virginia, United States
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Austria
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
🇧🇷Salvador, Bahia, Brazil
CRIO - Centro Regional Integrado de Oncologia
🇧🇷Fortaleza, Ceara, Brazil
Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI
🇧🇷Cachoeiro de Itapemirim, Espirito Santo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
🇧🇷Vitoria, Espirito Santo, Brazil
Cetus Oncologia S.A. Unidade Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
🇧🇷Ipatinga, Minas Gerais, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
🇧🇷Curitiba, Parana, Brazil
Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
🇧🇷Londrina, Parana, Brazil
Hospital Tacchini
🇧🇷Bento Goncalves, Rio Grande Do Sul, Brazil
Oncosite Centro De Pesquisa Clinica Em Oncologia
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Hospital da Cidade de Passo Fundo - HCPF
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
🇧🇷Pelotas, Rio Grande Do Sul, Brazil
Associacao dos Functionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles (H
🇧🇷Porto Alegre Rio Grande Do Sul, Rio Grande Do Sul, Brazil
Hospital Bruno Born
🇧🇷Lajeado, RS, Brazil
Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul
🇧🇷Porto Alegre, RS, Brazil
Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
🇧🇷Chapeco, Santa Catarina, Brazil
CEPEN Centro de Pesquisa e Ensino em Sade de Santa Catarina.
🇧🇷Florianopolis, Santa Catarina, Brazil
Centro de Ensino e Pesquisa Reichow
🇧🇷Jardim Blumenau, Santa Catarina, Brazil
Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
🇧🇷Joinville, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
🇧🇷Barretos, Sao Paulo, Brazil
Centro Oncologico Mogi das Cruzes
🇧🇷Mogi das Cruzes, Sao Paulo, Brazil
Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC
🇧🇷Ribeirao Preto, Sao Paulo, Brazil
Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia
🇧🇷Santo Andre, Sao Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do R
🇧🇷Sao Jose do Rio Preto, Sao Paulo, Brazil
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, SP, Brazil
Hospital Nossa Senhora das Gracas
🇧🇷Canoas, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba
🇧🇷Curitiba, Brazil
Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio
🇧🇷Porto Alegre, Brazil
Hospital Sao Rafael
🇧🇷Salvador, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
🇧🇷Sao Paulo, Brazil
Instituto Brasileiro de Controle do Cancer - IBCC Oncologia
🇧🇷Sao Paulo, Brazil
MHAT Dobrich AD
🇧🇬Dobich, Dobrich, Bulgaria
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
🇧🇬Sofia, Sofiya-Grad, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed
🇧🇬Sofia, Bulgaria
Centro de Investigaciones Clinicas Vina del Mar Ltda.
🇨🇱Vina del Mar, Region De Valparaiso, Chile
Clinica Santa Maria
🇨🇱Santiago, Region Metropolitana, Chile
Cdiem
🇨🇱Providencia, Region Metropolotana, Chile
Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
🇨🇱Vina Del Mar, Valparaiso, Chile
K2 Oncology
🇨🇱Santiago de Chile, Chile
Centro de Oncologa de Precisin
🇨🇱Santiago, Chile
Icegclinic Research and Care
🇨🇱Santiago, Chile
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
🇫🇷Bordeaux, France
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
🇫🇷Limoges, France
Hopital Europeen Marseille
🇫🇷Marseille, France
Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier
🇫🇷Montpellier, France
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
🇫🇷Nimes, France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
🇫🇷Toulon, France
Clinique Teissier
🇫🇷Valenciennes, France
Hopital Robert Schuman
🇫🇷Vantoux, France
High Technology Hospital Medcenter LTD
🇬🇪Batumi, Georgia
LLC Todua Clinic
🇬🇪Tbilisi, Georgia
TIM -Tbilisi Institute of Medicine
🇬🇪Tbilisi, Georgia
New Hospitals
🇬🇪Tbilisi, Georgia
Medulla - Clinics And Medical Centers
🇬🇪Tbilisi, Georgia
Studienzentrum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut
🇩🇪Landshut, Germany
FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH
🇩🇪Neumuenster, Germany
ASL Napoli 1 Centro-Ospedale del Mare
🇮🇹Napoli, Italy
AUSL Della Romagna - Ospedale S.Maria delle Croci
🇮🇹Ravenna, Italy
S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
🇮🇹Sondrio, Italy
Japan Community Healthcare Organization Chukyo Hospital
🇯🇵Nagoya, Aichi, Japan
Funabashi Municipal Medical Center
🇯🇵Funabashi-shi, Chiba, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Aso Iizuka Hospital
🇯🇵Iizuka-shi, Fukuoka, Japan
Japanese Red Cross Maebashi Hospital
🇯🇵Maebashi-shi, Gunma, Japan
Chugoku Central Hospital
🇯🇵Fukuyama city, Hiroshima, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima-city, Hiroshima, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa City,, Hokkaido, Japan, Japan
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Hyogo, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Kanagawa, Japan
Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
🇯🇵Kumamoto city, Kumamoto, Japan
Osaki Citizen Hospital
🇯🇵Osaki, Miyagi, Japan
Miyazaki Prefectural Miyazaki Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
NHO Kinki Chuo Chest Medical Center
🇯🇵Sakai-city,, Osaka Japan, Japan
Hamamatsu Medical Center
🇯🇵Hamamatsu City,, Shizuoka, Japan, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Ome Medical Center
🇯🇵Ome-shi, Tokyo, Japan
Nippon Medical School Musashikosugi Hospital
🇯🇵Kanagawa, Japan
Kawaguchi Municipal Medical Center
🇯🇵Saitama, Japan
Chungbuk National University Hospital
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
The Catholic University Of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju-si, Jeollabuk-do, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Kedah, Malaysia
Hospital Raja Perempuan Zainab II
🇲🇾Kota Bharu, Kelantan, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
Hospital Canselor Tuanku Muhriz UKM
🇲🇾Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Universidad de Guadalajara - Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Oncocare
🇵🇪Lima, Peru
Clinica Internacional S.A. Sede San Borja
🇵🇪Lima, Peru
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-Pomorskie, Poland
Instytut MSF Sp. z o.o.
🇵🇱Lodz, Poland
NZOZ Neuromed M. i M. Nastaj Sp.P.
🇵🇱Lublin, Poland
NZOZ Medpolonia Sp. Z o.o.
🇵🇱Poznan, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
🇵🇱Slupsk, Poland
Clincial Centre of Serbia
🇷🇸Belgrade, Serbia
University Clinical Centre of Kragujevac
🇷🇸Kragujevac, Serbia
Institute for Pulmonary Diseases of Vojvodina
🇷🇸Sremska Kamenica, Serbia
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcon, Spain
Hospital General Universitario de Elche
🇪🇸Alicante, Spain
UOMI Cancer Center-Clinica Tres Torres
🇪🇸Barcelona, Spain
Hospital Quironsalud Barcelona
🇪🇸Barcelona, Spain
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
🇪🇸Jaen, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Quironsalud Malaga
🇪🇸Malaga, Spain
Hospital De Mataro
🇪🇸Mataro, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Nuestra Senora De Valme
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Seville, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
🇪🇸Valencia, Spain
Hospital Quironsalud Valencia
🇪🇸Valencia, Spain
Tri-Service General Hospital
🇨🇳Neihu, Taipei, Taiwan
National Taiwan University Hospital (NTUH)
🇨🇳Taipei, Zhongzheng Dist, Taiwan
Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation
🇨🇳Chia-Yi, Taiwan
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
🇨🇳Douliu City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung County, Taiwan
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
🇨🇳New Taipei City, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
🇹🇭Bangkoknoi, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
🇹🇭Muang, Chiang Mai, Thailand
Chiangrai Prachanukroh Hospital
🇹🇭Muang, Chiang Rai, Thailand
Naresuan University Hospital
🇹🇭Muang, Phitsanulok, Thailand
Prince Of Songkla Hospital, Prince Of Songkhla University
🇹🇭Hat-Yai, Songkhla, Thailand
Vajira Hospital
🇹🇭Bangkok, Thailand
King Chulalongkorn Memorial Hospital, Chulalongkom University
🇹🇭Bangkok, Thailand
Trakya University Faculty of Medicine
🇹🇷Iskender, Edirne, Turkey
Istanbul Medeniyet University Medical Faculty
🇹🇷Kadikoy, Istanbul, Turkey
Medical Park Seyhan Hospital
🇹🇷Adana, Turkey
Adana City Training and Research Hospinal
🇹🇷Adana, Turkey
Gulhane Training and Research Hospital
🇹🇷Ankara, Turkey
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
🇹🇷Ankara, Turkey
Memorial Ankara Hospital
🇹🇷Ankara, Turkey
Liv Hospital Ankara
🇹🇷Ankara, Turkey
Ankara Bilkent City Hospital
🇹🇷Ankara, Turkey
Uludag University Medical Faculty
🇹🇷Bursa, Turkey
Bezmialem Foundation University Medical Faculty
🇹🇷Istanbul, Turkey
Necmettin Erbakan University Meram Medical Faculty
🇹🇷Konya, Turkey
Sakarya Universitesi Tip Fakultesi
🇹🇷Sakarya, Turkey
Ondokuz Mayis University Health Practice and Research Hospital
🇹🇷Samsun, Turkey
Namik Kemal Universitesi Hastanesi
🇹🇷Tekirdag, Turkey