A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

Study summary

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPembrolizumab Formulated with Berahyaluronidase Alfa and Pemetrexed

Plus 7 other study approaches.

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 Aug 26, 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?110 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

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 Formulated with Berahyaluronidase Alfa; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Biological: Pembrolizumab; Drug: Filgrastim; Drug: Pegylated filgrastim

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→

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

The key inclusion and

Reasons someone may not be able to joinExclusion criteria

include but are not limited to the following: Inclusion Criteria:
Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
Has a life expectancy of at least 3 months

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

Study sites

U.S. locations

St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)Phoenix, Arizona
Clermont Oncology Center ( Site 0018)Clermont, Florida
Mid Florida Hematology and Oncology Center ( Site 0010)Orange City, Florida
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)Chicago, Illinois
Orchard Healthcare Research Inc. ( Site 0011)Skokie, Illinois
Franciscan Health Lafayette East ( Site 0020)Lafayette, Indiana
Mercy Health-Paducah Cancer Center ( Site 0006)Paducah, Kentucky
Hattiesburg Clinic Hematology/Oncology ( Site 0008)Hattiesburg, Mississippi
Central Care Cancer Center - Bolivar ( Site 0017)Bolivar, Missouri
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)Ciudad Autonoma de Buenos Aires, Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)Mar del Plata, Buenos Aires
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)Buenos Aires, Buenos Aires F.D.

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 26, 2026. Always confirm current availability with the study team.

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