Clinical Trials in Japan / NCT06311721
Active, not recruiting
Phase 3
A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
NCT06311721 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
ABP 234: Intravenous administration
Pembrolizumab (US): Intravenous administration
Pembrolizumab (EU): Intravenous administration
Study summary
The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).
Eligibility
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 outcome measure(s)
- Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 — 21 days
- AUC21d of pembrolizumab (US) — 21 days
- AUC21d of pembrolizumab (EU) — 21 days
- AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234 — Week 16 through Week 19
- AUCtau_ss of pembrolizumab (US) — Week 16 through Week 19
- AUCtau_ss of pembrolizumab (EU) — Week 16 through Week 19
Trial sites (218)
| Facility | City | Region | Status |
|---|---|---|---|
| Precision NextGen Oncology and Research Center | Beverly Hills | California | |
| TOI Clinical Research | Cerritos | California | |
| Cancer and Blood Specialty Clinic (CBSC) | Los Alamitos | California | |
| Valkyrie Clinical Trials | Los Angeles | California | |
| PIH Health Hospital | Whittier | California | |
| Millennium Oncology - Hollywood | Hollywood | Florida | |
| BRCR Medical Center Inc. | Tamarac | Florida | |
| Accellacare Duly | Plainfield | Illinois | |
| Accellacare of McFarland | Ames | Iowa | |
| Detroit Clinical Research Center, PC | Farmington Hills | Michigan | |
| North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists | Shirley | New York | |
| Gabrail Cancer Center Research | Canton | Ohio | |
| Millennium Research and Clinical Development, LLC | Houston | Texas | |
| Texas Oncology, P.A | San Antonio | Texas | |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Wytheville | Virginia | |
| Instituto de Investigaciones Clinicas Mar del Plata | Mar del Plata | Buenos Aires | |
| Centro de Investigacion Pergamino SA | Pergamino | Buenos Aires | |
| Fundacion ARS Medica | San Salvador de Jujuy | Jujuy Province | |
| Sanatorio Britanico De Rosario | Rosario | Santa Fe Province | |
| Hospital Provincial del Centenario | Rosario | Santa Fe Province | |
| IONC - Instituto Oncologico de Cordoba | Córdoba | Argentina | |
| Klinikum Klagenfurt am Woerthersee | Klagenfurt | Austria | |
| Ordensklinikum Linz GmbH Elisabethinen | Linz | Austria | |
| CRIO - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | |
| OC Oncoclinicas Oncovida | Brasília | Destrito Federal | |
| Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI | Cachoeiro de Itapemirim | Espírito Santo | |
| Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita | Vitória | Espírito Santo | |
| Hospital Santa Izabel, Santa Casa de Misericordia da Bahia | Salvador | Estado de Bahia | |
| Cetus Oncologia S.A. Unidade Belo Horizonte | Belo Horizonte | Minas Gerais | |
| Nucleo de Ensino Pesquisa e Inovacao Mario Penna | Belo Horizonte | Minas Gerais | |
| Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I | Ipatinga | Minas Gerais | |
| Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner | Curitiba | Paraná | |
| Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL | Londrina | Paraná | |
| Liga Contra o Cancer | Natal | Rio Grande do Norte | |
| Hospital Tacchini | Bento Gonçalves | Rio Grande do Sul | |
| Oncosite Centro De Pesquisa Clinica Em Oncologia | Ijuí | Rio Grande do Sul | |
| Hospital Bruno Born | Lajeado | Rio Grande do Sul | |
| Hospital da Cidade de Passo Fundo - HCPF | Passo Fundo | Rio Grande do Sul | |
| Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks) | Pelotas | Rio Grande do Sul | |
| Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul | Porto Alegre | Rio Grande do Sul |
+ 178 more sites — see the full list on the official registry below.
More Amgen trials in Japan
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Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06311721 on ClinicalTrials.gov ↗ ← All trials in Japan