A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Sponsor: Amgen
Sponsor score: 60
ClinicalTrials ID:NCT06311721
This study evaluates the efficacy of ABP 234 versus pembrolizumab in adults with stage IV non-squamous NSCLC. Eligible participants must have measurable disease, no prior systemic treatment, and available tumor tissue for biomarker analysis. Interventions include intravenous ABP 234 and pembrolizumab (US/EU). Participants must have an ECOG score of 0 or 1 and be negative for EGFR, ALK, and ROS-1.
Patient Parameters
| Parameter | Options |
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Program Overview
The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).
Eligibility 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
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Precision NextGen Oncology and Research Center | 90212 | Beverly Hills | California |
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| PIH Health Hospital | 90602 | Whittier | California |
| BRCR Medical Center Inc. | 33321 | Tamarac | Florida |
| Accellacare Duly | 60585 | Plainfield | Illinois |
| Detroit Clinical Research Center, PC | 48334 | Farmington Hills | Michigan |
| Gabrail Cancer Center Research | 44718 | Canton | Ohio |
| Millenium Research & Clinical Development | 77090 | Houston | Texas |
| Texas Oncology, P.A | 78217 | San Antonio | Texas |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | 24382 | Wytheville | Virginia |
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