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)
Public ClinicalTrials.gov record NCT05722015. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05722015
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 377 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Formulated with Berahyaluronidase Alfa Biological
- Pemetrexed Drug
- Cisplatin Drug
- Carboplatin Drug
- Paclitaxel Drug
- Nab-paclitaxel Drug
- Pembrolizumab Biological
- Filgrastim Drug
- Pegylated filgrastim Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2023 (Actual)
- Primary completion
- Jul 12, 2024 (Actual)
- Completion
- May 22, 2028 (Estimated)
- Last update posted
- Aug 26, 2026
2023 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) | Phoenix | Arizona | 85004 | — |
| Clermont Oncology Center ( Site 0018) | Clermont | Florida | 34711 | — |
| Mid Florida Hematology and Oncology Center ( Site 0010) | Orange City | Florida | 32763 | — |
| University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022) | Chicago | Illinois | 60612 | — |
| Orchard Healthcare Research Inc. ( Site 0011) | Skokie | Illinois | 60077 | — |
| Franciscan Health Lafayette East ( Site 0020) | Lafayette | Indiana | 47905 | — |
| Mercy Health-Paducah Cancer Center ( Site 0006) | Paducah | Kentucky | 42003 | — |
| Hattiesburg Clinic Hematology/Oncology ( Site 0008) | Hattiesburg | Mississippi | 39401 | — |
| Central Care Cancer Center - Bolivar ( Site 0017) | Bolivar | Missouri | 65613 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 101 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05722015, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05722015 live on ClinicalTrials.gov.