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

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

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

NCT06311721•Amgen

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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.

Locations (219)

Precision NextGen Oncology and Research Center

Beverly Hills, California, United States

TOI Clinical Research

Cerritos, California, United States

Cancer and Blood Specialty Clinic (CBSC)

Los Alamitos, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

PIH Health Hospital

Whittier, California, United States

Millennium Oncology - Hollywood

Hollywood, Florida, United States

BRCR Medical Center Inc.

Tamarac, Florida, United States

Accellacare Duly

Plainfield, Illinois, United States

Accellacare of McFarland

Ames, Iowa, United States

Detroit Clinical Research Center, PC

Farmington Hills, Michigan, United States

Key Dates

Start Date

September 9, 2024

Primary Completion Date

February 14, 2028

Completion Date

May 29, 2028

Last Updated

January 27, 2026

Enrollment

315

ACTUAL participants

Conditions

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

Interventions

ABP 234

DRUG

Pembrolizumab (US)

DRUG

Pembrolizumab (EU)

DRUG

Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

NCT04974957

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

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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