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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

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