A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metasta… (NCT06311721) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
United States315 participantsStarted 2024-09-09
Plain-language summary
The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234
Timeframe: 21 days
2
AUC21d of pembrolizumab (US)
Timeframe: 21 days
3
AUC21d of pembrolizumab (EU)
Timeframe: 21 days
4
AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234
. Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.