Clinical trial NCT06311721: A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Official title: A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 927
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).


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.

Primary outcomes:
measure: Objective response (OR)
timeFrame: Week 49
measure: Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234
timeFrame: 21 days
measure: AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234
timeFrame: Week 16 through Week 19
Secondary outcomes:
measure: OR
timeFrame: Week 13
measure: OR
timeFrame: Week 31
measure: Duration of response (DOR)
timeFrame: Up to 2.5 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2.5 years
measure: Overall survival (OS)
timeFrame: Up to 2.5 years
measure: Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234
timeFrame: Day 1 up to Week 107
measure: Cmax_dose1 of pembrolizumab (US)
timeFrame: Day 1 up to Week 107
measure: Cmax_dose1 of pembrolizumab (EU)
timeFrame: Day 1 up to Week 107
measure: Time to maximum concentration following the first dose (tmax_dose1) of ABP 234
timeFrame: Day 1 up to Week 107
measure: Tmax_dose1 of pembrolizumab (US)
timeFrame: Day 1 up to Week 107
measure: Tmax_dose1 of pembrolizumab (EU)
timeFrame: Day 1 up to Week 107
measure: Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234
timeFrame: Week 16 through Week 19
measure: Cmax_ss of pembrolizumab (US)
timeFrame: Week 16 through Week 19
measure: Cmax_ss of of pembrolizumab (EU)
timeFrame: Week 16 through Week 19
measure: Time to maximum concentration at steady state (tmax_ss) of ABP 234
timeFrame: Week 16 through Week 19
measure: Tmax_ss of pembrolizumab (US)
timeFrame: Week 16 through Week 19
measure: Tmax_ss of pembrolizumab (EU)
timeFrame: Week 16 through Week 19
measure: Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234
timeFrame: Week 4
measure: Ctrough_w4 of pembrolizumab (US)
timeFrame: Week 4
measure: Ctrough_w4 of pembrolizumab (EU)
timeFrame: Week 4
measure: Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234
timeFrame: Week 16 through Week 19
measure: Ctrough_ss at pre-dose of pembrolizumab (US)
timeFrame: Week 16 through Week 19
measure: Ctrough_ss at pre-dose of pembrolizumab (EU)
timeFrame: Week 16 through Week 19
measure: AUC21d of pembrolizumab (US)
timeFrame: 21 days
measure: AUC21d of pembrolizumab (EU)
timeFrame: 21 days
measure: AUCtau_ss of pembrolizumab (US)
timeFrame: Week 16 through Week 19
measure: AUCtau_ss pembrolizumab (EU)
timeFrame: Week 16 through Week 19
measure: Number of participants who experience a Treatment-emergent adverse event
timeFrame: Up to 2.5 years
measure: Number of participants who experience a Treatment-emergent serious adverse event
timeFrame: Up to 2.5 years
measure: Number of participants who experience a Treatment-emergent adverse event of interest
timeFrame: Up to 2.5 years
measure: Number of participants who experience anti-drug antibodies (ADA)
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Precision NextGen Oncology and Research Center
state: California
city: Cerritos
country: United States
facility: TOI Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic (CBSC)
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Whittier
country: United States
facility: PIH Health Hospital
state: California
city: Tamarac
country: United States
facility: BRCR Medical Center Inc.
state: Florida
city: Plainfield
country: United States
facility: Accellacare Duly
state: Illinois
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center, PC
state: Michigan
city: Shirley
country: United States
facility: North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Houston
country: United States
facility: Millennium Research and Clinical Development, LLC
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, P.A
state: Texas
city: Wytheville
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Salvador
country: Brazil
facility: Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: CRIO - Centro Regional Integrado de Oncologia
state: Ceara
city: Cachoeiro de Itapemirim
country: Brazil
facility: Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI
state: Espirito Santo
city: Vitoria
country: Brazil
facility: Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia S.A. Unidade Belo Horizonte
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Nucleo de Ensino Pesquisa e Inovacao Mario Penna
state: Minas Gerais
city: Ipatinga
country: Brazil
facility: Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
state: Parana
city: Londrina
country: Brazil
facility: Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
state: Parana
city: Bento Goncalves
country: Brazil
facility: Hospital Tacchini
state: Rio Grande Do Sul
city: Ijui
country: Brazil
facility: Oncosite Centro De Pesquisa Clinica Em Oncologia
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo - HCPF
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
state: Rio Grande Do Sul
city: Porto Alegre Rio Grande Do Sul
country: Brazil
facility: Associacao dos Functionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles (H
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: RS
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul
state: RS
city: Chapeco
country: Brazil
facility: Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
state: Santa Catarina
city: Florianopolis
country: Brazil
facility: CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina
state: Santa Catarina
city: Jardim Blumenau
country: Brazil
facility: Centro de Ensino e Pesquisa Reichow
state: Santa Catarina
city: Joinville
country: Brazil
facility: Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: Sao Paulo
city: Mogi das Cruzes
country: Brazil
facility: Centro Oncologico Mogi das Cruzes
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do R
state: Sao Paulo
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: SP
city: Canoas
country: Brazil
facility: Hospital Nossa Senhora das Gracas
city: Curitiba
country: Brazil
facility: CIONC - Centro Integrado de Oncologia de Curitiba
city: Porto Alegre
country: Brazil
facility: Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cancer (INCA)
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz (HAOC)
city: Sao Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Cancer - IBCC Oncologia
city: Sofia
country: Bulgaria
facility: University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
state: Sofiya-Grad
city: Dobrich
country: Bulgaria
facility: MHAT Dobrich AD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sofiamed
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar Ltda.
state: Region De Valparaiso
city: Providencia
country: Chile
facility: Cdiem
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clinica Santa Maria
state: Region Metropolitana
city: Vina Del Mar
country: Chile
facility: Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
state: Valparaiso
city: Santiago de Chile
country: Chile
facility: K2 Oncology
city: Santiago
country: Chile
facility: Centro de Oncologa de Precisin
city: Santiago
country: Chile
facility: Icegclinic Research and Care
city: Bordeaux Cedex
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
city: Marseille
country: France
facility: Hopital Europeen Marseille
city: Montpellier
country: France
facility: Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier
city: Nimes
country: France
facility: Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
city: Valenciennes
country: France
facility: Clinique Teissier
city: Vantoux
country: France
facility: Hopital Robert Schuman
city: Batumi
country: Georgia
facility: High Technology Hospital Medcenter LTD
city: Tbilisi
country: Georgia
facility: LLC Todua Clinic
city: Tbilisi
country: Georgia
facility: TIM -Tbilisi Institute of Medicine
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Tbilisi
country: Georgia
facility: Medulla - Clinics And Medical Centers
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Landshut
country: Germany
facility: Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut
city: Neumuenster
country: Germany
facility: FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH
city: Napoli
country: Italy
facility: ASL Napoli 1 Centro-Ospedale del Mare
city: Ravenna
country: Italy
facility: AUSL Della Romagna - Ospedale S.Maria delle Croci
city: Nagoya
country: Japan
facility: Japan Community Healthcare Organization Chukyo Hospital
state: Aichi
city: Funabashi-shi
country: Japan
facility: Funabashi Municipal Medical Center
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Iizuka-shi
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Japanese Red Cross Maebashi Hospital
state: Gunma
city: Fukuyama city
country: Japan
facility: Chugoku Central Hospital
state: Hiroshima
city: Hiroshima-city
country: Japan
facility: Hiroshima Prefectural Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Osaki
country: Japan
facility: Osaki Citizen Hospital
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital
state: Miyazaki
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Sakai-city,
country: Japan
facility: NHO Kinki Chuo Chest Medical Center
state: Osaka Japan
city: Hamamatsu City
country: Japan
facility: Hamamatsu Medical Center
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Ome-shi
country: Japan
facility: Ome Medical Center
state: Tokyo
city: Kumamoto
country: Japan
facility: Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
city: Saitama
country: Japan
facility: Kawaguchi Municipal Medical Center
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea, St. Vincent's Hospital
state: Gyeonggi
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz UKM
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Davao
country: Philippines
facility: Davao Doctors Hospital
state: Davao Del Sur
city: Quezon City
country: Philippines
facility: Veterans Memorial Medical Center
state: Metro Manila
city: Bacolod City
country: Philippines
facility: Riverside Medical Center Inc
state: Negros Occidental
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
state: Kujawsko-Pomorskie
city: Lodz
country: Poland
facility: Instytut MSF Sp. z o.o.
city: Lublin
country: Poland
facility: NZOZ Neuromed M. i M. Nastaj Sp.P.
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o.o.
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
city: Belgrade
country: Serbia
facility: Clincial Centre of Serbia
city: Kragujevac
country: Serbia
facility: University Clinical Centre of Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Alicante
country: Spain
facility: Hospital General Universitario de Elche
city: Barcelona
country: Spain
facility: UOMI Cancer Center-Clinica Tres Torres
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Malaga
country: Spain
facility: Hospital Quironsalud Malaga
city: Mataro
country: Spain
facility: Hospital De Mataro
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Senora De Valme
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Quironsalud Valencia
city: Valencia
country: Spain
facility: Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
city: Neihu
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
state: Zhongzheng Dist
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation
city: Douliu City
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
city: Kaohsiung County
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkoknoi
country: Thailand
facility: Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
state: Bangkok
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
state: Chiang Mai
city: Muang
country: Thailand
facility: Chiangrai Prachanukroh Hospital
state: Chiang Rai
city: Bangkok
country: Thailand
facility: Chulalongkorn University
state: Krung Thep Maha Nakhon
city: Talat Bang Khen
country: Thailand
facility: Chulabhorn Hospital
state: Lak Si
city: Muang
country: Thailand
facility: Naresuan University Hospital
state: Phitsanulok
city: Hat-Yai
country: Thailand
facility: Prince Of Songkla Hospital, Prince Of Songkhla University
state: Songkhla
city: Bangkok
country: Thailand
facility: Vajira Hospital
city: Kecioeren
country: Turkey
facility: Gulhane Training and Research Hospital
state: Ankara
city: Iskender
country: Turkey
facility: Trakya University Faculty of Medicine
state: Edirne
city: Atakum
country: Turkey
facility: Ondokuz Mayis University Health Practice and Research Hospital
state: Samsun
city: Adana
country: Turkey
facility: Medical Park Seyhan Hospital
city: Adana
country: Turkey
facility: Adana City Training and Research Hospinal
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hospital
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
city: Ankara
country: Turkey
facility: Liv Hospital Ankara
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Gaziantep
country: Turkey
facility: Medical Point Gaziantep Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Foundation University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Medical Faculty
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Tip Fakultesi
city: Tekirdag
country: Turkey
facility: Namik Kemal Universitesi Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: