Trial Title:
A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
NCT ID:
NCT06311721
Condition:
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
ABP 234
Description:
Intravenous administration
Arm group label:
ABP 234
Intervention type:
Drug
Intervention name:
Pembrolizumab (US)
Description:
Intravenous administration
Arm group label:
Pembrolizumab (US)
Other name:
Keytruda®
Intervention type:
Drug
Intervention name:
Pembrolizumab (EU)
Description:
Intravenous administration
Arm group label:
Pembrolizumab (EU)
Other name:
Keytruda®
Summary:
The primary objective of this study is to compare the efficacy of ABP 234 with the
pembrolizumab reference product (Keytruda®).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Precision NextGen Oncology and Research Center
Address:
City:
Beverly Hills
Zip:
90212
Country:
United States
Status:
Recruiting
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Facility:
Name:
PIH Health Hospital
Address:
City:
Whittier
Zip:
90602
Country:
United States
Status:
Recruiting
Facility:
Name:
Accellacare Duly
Address:
City:
Plainfield
Zip:
60585
Country:
United States
Status:
Recruiting
Facility:
Name:
Millenium Research & Clinical Development
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology, P.A
Address:
City:
San Antonio
Zip:
78217
Country:
United States
Status:
Recruiting
Facility:
Name:
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Address:
City:
Vina del Mar
Zip:
2540364
Country:
Chile
Status:
Recruiting
Facility:
Name:
Cdiem
Address:
City:
Providencia
Zip:
7500859
Country:
Chile
Status:
Recruiting
Facility:
Name:
LLC Todua Clinic
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
KLE University - Jawaharlal Nehru Medical College (JNMC)
Address:
City:
Belgaum
Zip:
590010
Country:
India
Status:
Terminated
Facility:
Name:
Bhakti Vedanta Hospital and Research Institute
Address:
City:
Thane
Zip:
401107
Country:
India
Status:
Terminated
Facility:
Name:
Irccs - Centro Di Riferimento Oncologico Della Basilicata (Crob)
Address:
City:
Rionero In Vulture
Zip:
85028
Country:
Italy
Status:
Terminated
Facility:
Name:
Japan Community Healthcare Organization Chukyo Hospital
Address:
City:
Nagoya
Zip:
457-8510
Country:
Japan
Status:
Recruiting
Facility:
Name:
Chugoku Central Hospital
Address:
City:
Fukuyama city
Zip:
720-0001
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hiroshima Prefectural Hospital
Address:
City:
Hiroshima-city
Zip:
734-8530
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hyogo Prefectural Amagasaki General Medical Center
Address:
City:
Amagasaki
Zip:
660-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yokohama City University Hospital
Address:
City:
Yokohama
Zip:
236-0004
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaki Citizen Hospital
Address:
City:
Osaki
Zip:
989-6183
Country:
Japan
Status:
Recruiting
Facility:
Name:
Miyazaki Prefectural Miyazaki Hospital
Address:
City:
Miyazaki-shi
Zip:
880-8510
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ome Medical Center
Address:
City:
Ome-shi
Zip:
198-0042
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kangbuk Samsung Hospital
Address:
City:
Seoul
Zip:
03181
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea Seoul St. Mary's Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Centra Medyczne Medyceusz Sp. z o. o.
Address:
City:
Lodz
Zip:
91-053
Country:
Poland
Status:
Terminated
Facility:
Name:
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
Address:
City:
Jaen
Zip:
23007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Start date:
September 9, 2024
Completion date:
June 17, 2026
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311721
http://www.amgentrials.com