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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 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.

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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.

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

FieldValue
Enrollment Target 460 participants
Start Date 2022-03-24
Est. Completion 2027-06-07
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT05224141

The ClinicalTrials.gov registry entry for NCT05224141 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 235-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (96% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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