Active Not RecruitingPhase 3NCT06698042
Official study title

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

Study summary

Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body. Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPembrolizumab (+) Berahyaluronidase alfa and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 21, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?67 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Biological: Pembrolizumab (+) Berahyaluronidase alfa; Biological: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Providence Medical Foundation ( Site 0117)Fullerton, California
  • Illinois Cancer Care ( Site 0101)Peoria, Illinois
  • Montefiore Medical Center ( Site 0104)The Bronx, New York
  • University of Cincinnati Medical Center ( Site 0112)Cincinnati, Ohio
  • Beijing Peking Union Medical College Hospital ( Site 5000)Beijing, Beijing Municipality
  • Chongqing University Three Gorges Hospital ( Site 5018)Chongqing, Chongqing Municipality
  • Fujian Province Cancer Hospital ( Site 5007)Fuzhou, Fujian
  • The First Affiliated hospital of Xiamen University ( Site 5008)Xiamen, Fujian
  • The first affiliated hospital, Sun Yat-Sen university ( Site 5011)Guangzhou, Guangdong
  • Southern Medical University Nanfang Hospital ( Site 5003)Guangzhou, Guangdong
  • Huizhou Central People's Hospital ( Site 5004)Huizhou, Guangdong
  • Jiangmen Center Hospital ( Site 5001)Jiangmen, Guangdong

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2026. Always confirm current availability with the study team.

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