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Comparing ABP 234 and Keytruda® for advanced lung cancer

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

Phase 3 Interventional Amgen · NCT06311721

This study is testing if a new drug called ABP 234 works better than the standard treatment Keytruda® for adults with advanced lung cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment927 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, pembrolizumab
Locations169 sites (Beverly Hills, California and 168 other locations)
Trial IDNCT06311721 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of ABP 234 compared to the established treatment Keytruda® (pembrolizumab) in patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Participants must be at least 18 years old and have confirmed stage IV NSCLC without prior systemic treatment for advanced disease. The study will involve measuring disease progression and response to treatment using established criteria. Tumor tissue samples will also be collected for biomarker analysis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stage IV non-squamous NSCLC who have not received prior systemic treatment.

Not a fit: Patients with small cell lung cancer or those who have received prior systemic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Beverly Hills, California and 168 other locations

+119 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.