ACTIVE_NOT_RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-09-09
Study Completion:2028-05-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06311721

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At least 18 years of age.
  2. 2. Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
  3. 3. Participant has no prior systemic treatment for advanced disease.
  4. 4. Measurable disease according to RECIST v1.1.
  5. 5. Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
  6. 6. Eastern Cooperative Oncology Group performance status score 0 or 1.
  7. 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. 8. Have a life expectancy of at least 3 months.
  1. 1. Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
  2. 2. Participant has active central nervous system metastases not previously treated.
  3. 3. Participant has active or known immune-mediated disorders.
  4. 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. 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.

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Precision NextGen Oncology and Research Center
Beverly Hills, California, 90212
United States
TOI Clinical Research
Cerritos, California, 90703
United States
Cancer and Blood Specialty Clinic (CBSC)
Los Alamitos, California, 90720-3309
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
PIH Health Hospital
Whittier, California, 90602
United States
Millennium Oncology - Hollywood
Hollywood, Florida, 33024
United States
BRCR Medical Center Inc.
Tamarac, Florida, 33321
United States
Accellacare Duly
Plainfield, Illinois, 60585
United States
Accellacare of McFarland
Ames, Iowa, 50010
United States
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, 48334
United States
North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists
Shirley, New York, 11967
United States
Gabrail Cancer Center Research
Canton, Ohio, 44718
United States
Millennium Research and Clinical Development, LLC
Houston, Texas, 77090
United States
Texas Oncology, P.A
San Antonio, Texas, 78217
United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2028-05-29

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2028-05-29

Terms related to this study

Additional Relevant MeSH Terms

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