Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
Public ClinicalTrials.gov record NCT04956692. 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 Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.
Study identification
- NCT ID
- NCT04956692
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 531 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab SC Biological
- Pembrolizumab IV Biological
- Paclitaxel Drug
- Nab-Paclitaxel Drug
- Carboplatin Drug
- Cisplatin Drug
- Pemetrexed 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
- Aug 5, 2021 (Actual)
- Primary completion
- Apr 4, 2023 (Actual)
- Completion
- Aug 24, 2026 (Actual)
- Last update posted
- Oct 7, 2026
2021 – 2026
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Bernards Medical Center ( Site 0103) | Jonesboro | Arkansas | 72401 | — |
| St Joseph Heritage Healthcare-Oncology ( Site 0102) | Fullerton | California | 92835 | — |
| Cancer Blood and Specialty Clinic ( Site 0105) | Los Alamitos | California | 90720 | — |
| PIH Health Hematology Medical Oncology ( Site 0106) | Whittier | California | 90602 | — |
| Holy Cross Hospital ( Site 0017) | Fort Lauderdale | Florida | 33308 | — |
| Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104) | Hollywood | Florida | 33021 | — |
| Advent Health ( Site 0013) | Orlando | Florida | 32804 | — |
| Fort Wayne Medical Oncology and Hematology ( Site 0101) | Fort Wayne | Indiana | 46804 | — |
| Baptist Health Lexington ( Site 0099) | Lexington | Kentucky | 40503 | — |
| St Luke's Hospital - Kansas City ( Site 0033) | Kansas City | Missouri | 64111 | — |
| St. Vincent Frontier Cancer Center ( Site 0058) | Billings | Montana | 59102 | — |
| Montefiore Medical Center [Bronx, NY] ( Site 0040) | The Bronx | New York | 10461 | — |
| The University of Tennessee Medical Center ( Site 0050) | Knoxville | Tennessee | 37920 | — |
| Tennessee Oncology ( Site 0051) | Nashville | Tennessee | 37203 | — |
| Oncology Consultants, PA ( Site 0052) | Houston | Texas | 77030 | — |
| Millennium Physicians - Oncology ( Site 0097) | Houston | Texas | 77090 | — |
| Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100) | Blacksburg | Virginia | 24060 | — |
| West Virginia University ( Site 0056) | Morgantown | West Virginia | 26506 | — |
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 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04956692, 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 Oct 7, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04956692 live on ClinicalTrials.gov.