A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Description

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

Conditions

Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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

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

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Condition
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Precision NextGen Oncology and Research Center, Beverly Hills, California, United States, 90212

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Whittier

PIH Health Hospital, Whittier, California, United States, 90602

Plainfield

Accellacare Duly, Plainfield, Illinois, United States, 60585

Farmington Hills

Detroit Clinical Research Center, PC, Farmington Hills, Michigan, United States, 48334

Houston

Millenium Research & Clinical Development, Houston, Texas, United States, 77090

San Antonio

Texas Oncology, P.A, San Antonio, Texas, United States, 78217

Wytheville

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Wytheville, Virginia, United States, 24382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-10-22