Who is eligible for clinical trial NCT05224141?

Participants must meet the protocol's inclusion criteria for Small Cell Lung Carcinoma. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05224141 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-07-04

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) (NCT05224141)

A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (19 items).

Location: Infirmary Cancer Care ( Site 0022) — Mobile, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

The main inclusion criteria include but are not limited to the following:
Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Has a predicted life expectancy of \>3 months

Usually NOT eligible if any of the following apply:

Exclusion Criteria: The main exclusion criteria include but are not limited to the following:
Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
Has received prior treatment for Small Cell Lung Cancer (SCLC)
Is expected to require any other form of antineoplastic therapy for SCLC while on study
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (140 Sites)

Showing the first 25 of 140 sites.

Infirmary Cancer Care ( Site 0022) — Mobile, Alabama
Los Angeles Hematology Oncology Medical Group ( Site 0006) — Los Angeles, California
VA West Los Angeles Medical Center ( Site 0004) — Los Angeles, California
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) — Boca Raton, Florida
Fort Wayne Medical Oncology and Hematology ( Site 0013) — Fort Wayne, Indiana
Dana-Farber Cancer Institute ( Site 0018) — Boston, Massachusetts
Cancer and Hematology Centers of Western Michigan ( Site 0001) — Grand Rapids, Michigan
Hattiesburg Clinic Hematology/Oncology ( Site 0003) — Hattiesburg, Mississippi
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) — Lancaster, Pennsylvania
Blue Ridge Cancer Care ( Site 0015) — Blacksburg, Virginia
University of Virginia Cancer Center ( Site 0019) — Charlottesville, Virginia
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) — Ciudad Autonoma de Buenos Aires, Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) — Mar del Plata, Buenos Aires
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) — Buenos Aires, Buenos Aires F.D.
Hospital Provincial del Centenario ( Site 0205) — Rosario, Santa Fe Province
Sanatorio Parque ( Site 0202) — Rosario, Santa Fe Province
Nepean Hospital ( Site 2700) — Kingswood, New South Wales
Calvary Mater Newcastle ( Site 2703) — Waratah, New South Wales
Frankston Hospital-Oncology and Haematology ( Site 2702) — Frankston, Victoria
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) — Melbourne, Victoria
Medizinische Universität Graz ( Site 0504) — Graz, Styria
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505) — Linz, Upper Austria
Kepler Universitätsklinikum ( Site 0507) — Linz, Upper Austria
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502) — Vienna,
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501) — Vienna,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗