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Using pembrolizumab with berahyaluronidase alfa to treat metastatic non-small cell lung cancer

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06698042

This study is testing if a new way of giving a cancer treatment called pembrolizumab, combined with another drug, can help people with newly diagnosed metastatic non-small cell lung cancer feel better and live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionspembrolizumab, immunotherapy
Locations55 sites (Peoria, Illinois and 54 other locations)
Trial IDNCT06698042 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the effectiveness of pembrolizumab, an immunotherapy, combined with berahyaluronidase alfa for patients with newly diagnosed metastatic non-small cell lung cancer (NSCLC). The study aims to compare the pharmacokinetics of pembrolizumab when administered as an intravenous infusion versus a subcutaneous injection. Participants will be monitored for measurable disease progression and response to treatment over time. The goal is to identify the most effective method of delivering this treatment to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed squamous or nonsquamous NSCLC who have measurable disease and have not received prior systemic anticancer therapy for their metastatic condition.

Not a fit: Patients with small cell lung cancer, active central nervous system metastases, or those who have received prior systemic therapy for metastatic NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and convenient treatment option for patients with metastatic non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with pembrolizumab in treating NSCLC, but the combination with berahyaluronidase alfa is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.

Exclusion Criteria:

* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.

Where this trial is running

Peoria, Illinois and 54 other locations

+5 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 Lung CancerNon-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.