Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
Public ClinicalTrials.gov record NCT05609968. 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.
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Official title
An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).
Study identification
- NCT ID
- NCT05609968
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 614 participants
Conditions and interventions
Conditions
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 6, 2023 (Actual)
- Primary completion
- Jan 12, 2027 (Estimated)
- Completion
- Aug 23, 2028 (Estimated)
- Last update posted
- Dec 24, 2025
2023 – 2028
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Infirmary Cancer Care ( Site 0418) | Mobile | Alabama | 36607 | — |
| Profound Research LLC ( Site 0444) | Oceanside | California | 92056-4522 | — |
| Clermont Oncology Center ( Site 0421) | Clermont | Florida | 34711 | — |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417) | Miami | Florida | 33136 | — |
| Mid Florida Hematology and Oncology Center ( Site 0416) | Orange City | Florida | 32763 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407) | Marietta | Georgia | 30060 | — |
| Our Lady of the Lake RMC ( Site 0424) | Baton Rouge | Louisiana | 70808 | — |
| Henry Ford Hospital ( Site 0412) | Detroit | Michigan | 48202 | — |
| Profound Research LLC ( Site 0440) | Farmington Hills | Michigan | 48334 | — |
| Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425) | Minneapolis | Minnesota | 55407 | — |
| Basil Clinical ( Site 0441) | Inwood | New York | 11096 | — |
| White Plains Hospital-Center for Cancer Care ( Site 0403) | White Plains | New York | 10601 | — |
| Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408) | Portland | Oregon | 97227 | — |
| Oregon Health & Science University ( Site 0427) | Portland | Oregon | 97239 | — |
| Houston Methodist Hospital ( Site 0419) | Houston | Texas | 77030 | — |
| Central Texas Veterans health care ( Site 0414) | Temple | Texas | 76504 | — |
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 164 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05609968, 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 Dec 24, 2025 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05609968 live on ClinicalTrials.gov.