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
Inactive

ClinicalTrials ID:NCT06311721

Patient View

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

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

  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.

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