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) (NCT05722015)
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, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (15 items).
Location: St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (110 Sites)
Showing the first 25 of 110 sites.
- 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.
- Instituto Alexander Fleming ( Site 1008) — Buenos Aires, Buenos Aires F.D.
- Clinica Adventista Belgrano-Oncology ( Site 1004) — Buenos Aires, Buenos Aires F.D.
- Sanatorio Parque ( Site 1003) — Rosario, Santa Fe Province
- Hospital Italiano de Córdoba ( Site 1000) — Córdoba,
- CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102) — Fortaleza, Ceará
- Hospital de Cancer de Pernambuco ( Site 1107) — Recife, Pernambuco
- Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100) — Porto Alegre, Rio Grande do Sul
- Instituto Joinvilense de Hematologia e Oncologia ( Site 1101) — Joinville, Santa Catarina
- A. C. Camargo Cancer Center ( Site 1106) — São Paulo,
- IC La Serena Research ( Site 1207) — La Serena, Coquimbo Region
- Oncocentro Valdivia ( Site 1201) — Valdivia, Los Ríos Region
- FALP-UIDO ( Site 1203) — Santiago, Region M. de Santiago
- Oncovida ( Site 1209) — Santiago, Region M. de Santiago
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Non-small Cell Lung Cancer
- LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC — Birmingham, Alabama
- Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers — Sacramento, California
- A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) — Los Angeles, California
- A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer — Fayetteville, Arkansas
- A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. — Hot Springs, Arkansas
Explore by condition: All Metastatic Non-small Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.