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)
Running, not enrolling · Phase 3
Conditions studied: Metastatic Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT05722015
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 377
- Starts
- 2023-02-14
- Expected to finish
- 2028-05-22
- Last updated by the study team
- 2025-09-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clermont Oncology Center ( Site 0018) — Clermont, Florida, United States
- Mid Florida Hematology and Oncology Center ( Site 0010) — Orange City, Florida, United States
- University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022) — Chicago, Illinois, United States
- Orchard Healthcare Research Inc. ( Site 0011) — Skokie, Illinois, United States
- Franciscan Health Lafayette East ( Site 0020) — Lafayette, Indiana, United States
- Mercy Health-Paducah Cancer Center ( Site 0006) — Paducah, Kentucky, United States
- Hattiesburg Clinic Hematology/Oncology ( Site 0008) — Hattiesburg, Mississippi, United States
- Central Care Cancer Center - Bolivar ( Site 0017) — Bolivar, Missouri, United States
- Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001) — Mar del Plata, Buenos Aires, Argentina
- Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002) — Buenos Aires, Buenos Aires F.D., Argentina
- Instituto Alexander Fleming ( Site 1008) — Buenos Aires, Buenos Aires F.D., Argentina
- Clinica Adventista Belgrano-Oncology ( Site 1004) — Buenos Aires, Buenos Aires F.D., Argentina
- Sanatorio Parque ( Site 1003) — Rosario, Santa Fe Province, Argentina
- Hospital Italiano de Córdoba ( Site 1000) — Córdoba, Argentina
- CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102) — Fortaleza, Ceará, Brazil
- Hospital de Cancer de Pernambuco ( Site 1107) — Recife, Pernambuco, Brazil
- Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100) — Porto Alegre, Rio Grande do Sul, Brazil
- Instituto Joinvilense de Hematologia e Oncologia ( Site 1101) — Joinville, Santa Catarina, Brazil
- A. C. Camargo Cancer Center ( Site 1106) — São Paulo, Brazil
- IC La Serena Research ( Site 1207) — La Serena, Coquimbo Region, Chile
- Oncocentro Valdivia ( Site 1201) — Valdivia, Los Ríos Region, Chile
- FALP-UIDO ( Site 1203) — Santiago, Region M. de Santiago, Chile
- Oncovida ( Site 1209) — Santiago, Region M. de Santiago, Chile
- St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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