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Clinical Trials List

Protocol Number20210033
NCT Number(ClinicalTrials.gov Identfier)NCT06311721
Active

2024-05-01 - 2029-03-31

Phase III

Not yet recruiting10

Recruiting1

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/18

Investigators and Locations

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 賴學緯 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 賴俊良 無
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator JIN-YUAN SHIH 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE 無
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

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

Objectives

Primary Objectives • Compare the efficacy of ABP 234 with the reference drug pembrolizumab • Compare the pharmacokinetic (PK) profile of ABP 234 with the reference drug pembrolizumab Secondary Objectives • Compare the efficacy of ABP 234 with the reference drug pembrolizumab • Compare the pharmacokinetic (PK) profile of ABP 234 with the reference drug pembrolizumab • Compare the safety profile of ABP 234 with the reference drug pembrolizumab • Compare the immunogenicity of ABP 234 with the reference drug pembrolizumab

Test Drug

Injectables

Active Ingredient

ABP234
Pembrolizumab

Dosage Form

270
270

Dosage

25 MG/ML
100 mg/vial

Endpoints

-

Inclution Criteria

Inclusion Criteria:

At least 18 years of age.
Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
Participant has no prior systemic treatment for advanced disease.
Measurable disease according to RECIST v1.1.
Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
Eastern Cooperative Oncology Group performance status score 0 or 1.
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
Have a life expectancy of at least 3 months.

Exclusion Criteria

Exclusion Criteria:

Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
Participant has active central nervous system metastases not previously treated.
Participant has active or known immune-mediated disorders.
Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    927 participants

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