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NCT05609968 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
- 20
- Study locations
NCT05609968: Active Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.
NCT05609968 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 614 participants, above the 319-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (92% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05609968, a Phase 3 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
- 20
- Study locations
Study Summary
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%).
Primary Outcome
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as per the Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 is modified to follow a maxi
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Sacituzumab Govitecan
Study Locations (20)
Florida
- Clermont Oncology Center ( Site 0421) - Clermont
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417) - Miami
- Mid Florida Hematology and Oncology Center ( Site 0416) - Orange City
Michigan
- Henry Ford Hospital ( Site 0412) - Detroit
- Profound Research LLC ( Site 0440) - Farmington Hills
New York
- Basil Clinical ( Site 0441) - Inwood
- White Plains Hospital-Center for Cancer Care ( Site 0403) - White Plains
Oregon
- Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408) - Portland
- Oregon Health & Science University ( Site 0427) - Portland
Texas
- Houston Methodist Hospital ( Site 0419) - Houston
- Central Texas Veterans health care ( Site 0414) - Temple
Alabama
- Infirmary Cancer Care ( Site 0418) - Mobile
California
- Profound Research LLC ( Site 0444) - Oceanside
Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407) - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2023-02-06 |
| Est. Completion | 2028-08-23 |
| Phase | Phase 3 |
What the registry record for NCT05609968 still lists
NCT05609968 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, above the 319-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (92% higher).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05609968 names 20 study sites across 14 states, led by Florida, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT05609968 about?
NCT05609968 is a clinical study titled "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)". 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 blinde...
What is the current status of trial NCT05609968?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2023-02-06. Estimated completion is 2028-08-23.
What conditions does trial NCT05609968 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT05609968?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Sacituzumab Govitecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT05609968?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05609968 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05609968's enrollment target sits among peer trials
614 23rd of 130 higher than 108 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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