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NCT05224141 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)
A Phase 3 study of Small Cell Lung Carcinoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
- 20
- Study locations
NCT05224141: Active Phase 3 study of Small Cell Lung Carcinoma, sponsored by Merck Sharp & Dohme.
NCT05224141 is a Phase 3 study of Small Cell Lung Carcinoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 460 participants, above the 235-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (96% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05224141, a Phase 3 study of Small Cell Lung Carcinoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.
Primary Outcome
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.
Conditions Studied
Interventions
- BIOLOGICAL Atezolizumab
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Saline placebo
- BIOLOGICAL Pembrolizumab/Vibostolimab Co-Formulation
Study Locations (20)
California
- Los Angeles Hematology Oncology Medical Group ( Site 0006) - Los Angeles
- VA West Los Angeles Medical Center ( Site 0004) - Los Angeles
Virginia
- Blue Ridge Cancer Care ( Site 0015) - Blacksburg
- University of Virginia Cancer Center ( Site 0019) - Charlottesville
Buenos Aires
- Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) - Ciudad Autonoma de Buenos Aires
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) - Mar del Plata
Santa Fe Province
- Hospital Provincial del Centenario ( Site 0205) - Rosario
- Sanatorio Parque ( Site 0202) - Rosario
New South Wales
- Nepean Hospital ( Site 2700) - Kingswood
- Calvary Mater Newcastle ( Site 2703) - Waratah
Victoria
- Frankston Hospital-Oncology and Haematology ( Site 2702) - Frankston
- Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) - Melbourne
Alabama
- Infirmary Cancer Care ( Site 0022) - Mobile
Florida
- Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) - Boca Raton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2027-06-07 |
| Phase | Phase 3 |
What the registry record for NCT05224141 still lists
NCT05224141 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, above the 235-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (96% higher).
The record links to 1 condition, with Small Cell Lung Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT05224141 names 20 study sites across 14 states, led by California, Virginia, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT05224141 about?
NCT05224141 is a clinical study titled "Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)". This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatmen...
What is the current status of trial NCT05224141?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2022-03-24. Estimated completion is 2027-06-07.
What conditions does trial NCT05224141 study?
This clinical trial studies the following conditions: Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT05224141?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), Cisplatin (DRUG), Etoposide (DRUG), Saline placebo (DRUG), Pembrolizumab/Vibostolimab Co-Formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT05224141?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05224141 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05224141's enrollment target sits among peer trials
460 4th of 18 higher than 15 of 18 other Small Cell Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small Cell Lung Carcinoma 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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