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)
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.
Checked against the public recordLast updated Aug 26, 2026 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The key inclusion and exclusion 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 Exclusion Criteria: * Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has received prior systemic anticancer therapy for metastatic NSCLC * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids * Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has an active infection requiring systemic therapy * Has a history of human immunodeficiency virus (HIV) infection * Has a history of Hepatitis B or C * Has not adequately recovered from major surgery or has ongoing surgical complications * Has a history of allogenic tissue/solid organ transplant
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.