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NCT05224141Active, not recruitingPhase 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, 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)

Source: ClinicalTrials.gov · Last updated 8 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
460 (actual)
First submitted
25 Jan 2022
Start date
24 Mar 2022
Primary completion date
4 Jun 2024
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT05224141
EU CT number
2023-503517-30-00
EudraCT number
2021-005034-42

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 460
  • From 24 Mar 2022 to the primary completion date, 4 Jun 2024
  • 126 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 had an allogenic tissue/solid organ transplant
  • Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention

Other illness

  • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • 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
  • Has a known history of, or active, neurologic paraneoplastic syndrome
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection

Other

  • The main exclusion criteria include but are not limited to the following:
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has symptomatic ascites or pleural effusion

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (126)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AiresArgentinaUnknown status
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaUnknown status
Hospital Provincial del Centenario ( Site 0205)
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Sanatorio Parque ( Site 0202)
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaCompleted
Kepler Universitaetsklinikum GmbH
Coordinator of this site? Confirm its status
LinzAustriaCompleted
Ordensklinikum Linz GmbH
Coordinator of this site? Confirm its status
LinzAustriaCompleted
Krankenhaus Nord - Klinik Floridsdorf
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Wiener Gesundheitsverbund
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Frankston Hospital-Oncology and Haematology ( Site 2702)
Coordinator of this site? Confirm its status
FrankstonAustraliaUnknown status
Nepean Hospital ( Site 2700)
Coordinator of this site? Confirm its status
KingswoodAustraliaUnknown status
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Calvary Mater Newcastle ( Site 2703)
Coordinator of this site? Confirm its status
WaratahAustraliaUnknown status
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)
Coordinator of this site? Confirm its status
KingstonCanadaUnknown status
Lakeridge Health ( Site 0102)
Coordinator of this site? Confirm its status
OshawaCanadaUnknown status
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Peking Union Medical College Hospital ( Site 2921)
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
The First Hospital of Jilin University ( Site 2914)
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Jilin Cancer Hospital-GCP office ( Site 2909)
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Hunan Cancer Hospital ( Site 2907)
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
West China Hospital Sichuan University ( Site 2903)
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Sichuan Cancer hospital. ( Site 2923)
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Zhejiang Cancer Hospital-Oncology ( Site 2919)
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
Coordinator of this site? Confirm its status
HarbinChinaUnknown status
Anhui Cancer Hospital ( Site 2915)
Coordinator of this site? Confirm its status
HefeiChinaUnknown status
Shanghai Chest Hospital-Oncology department ( Site 2900)
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center ( Site 2908)
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
The First Affiliated Hospital of Soochow University ( Site 2913)
Coordinator of this site? Confirm its status
SuzhouChinaUnknown status
Hubei Cancer Hospital ( Site 2922)
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912)
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status
Henan Cancer Hospital ( Site 2916)
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status
SRH Wald-Klinikum Gera GmbH
Coordinator of this site? Confirm its status
GeraGermanyCompleted
LungenClinic Grosshansdorf GmbH
Coordinator of this site? Confirm its status
GrosshansdorfGermanyCompleted
Thoraxklinik At University Of Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainActive, not recruiting
Oulu University Hospital
Coordinator of this site? Confirm its status
OuluFinlandCompleted
Turku University Hospital
Coordinator of this site? Confirm its status
TurkuFinlandCompleted
Vaasa Central Hospital
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VaasaFinlandCompleted
Centre Hospitalier Universitaire De Limoges
Coordinator of this site? Confirm its status
Limoges Cedex 1FranceCompleted
Assistance Publique Hôpitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceCompleted
Centre Hospitalier Universitaire de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceCompleted
Heartlands Hospital-Oncology Research ( Site 2604)
Coordinator of this site? Confirm its status
BirminghamUnited KingdomUnknown status
The Christie-Clinical Research Facility ( Site 2607)
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Mount Vernon Hospital ( Site 2602)
Coordinator of this site? Confirm its status
NorthwoodUnited KingdomUnknown status
Henry Dunant Hospital Center
Coordinator of this site? Confirm its status
AthensGreeceCompleted
Thoracic General Hospital of Athens "I Sotiria"
Coordinator of this site? Confirm its status
AthensGreeceCompleted
Metropolitan Hospital
Coordinator of this site? Confirm its status
PireasGreeceCompleted
Athens Medical Center S.A.
Coordinator of this site? Confirm its status
ThessalonikiGreeceCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
Coordinator of this site? Confirm its status
KaposvárHungaryCompleted
Bacs-Kiskun Varmegyei Oktatokorhaz
Coordinator of this site? Confirm its status
KecskemétHungaryCompleted
Református Pulmonológiai Centrum
Coordinator of this site? Confirm its status
TörökbálintHungaryCompleted
St James's Hospital
Coordinator of this site? Confirm its status
Dublin 8IrelandCompleted
Beaumont Hospital
Coordinator of this site? Confirm its status
Dublin 9IrelandCompleted
Rambam Health Care Campus-Oncology ( Site 1301)
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Shaare Zedek Medical Center-Oncology ( Site 1300)
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Sheba Medical Center-ONCOLOGY ( Site 1302)
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyCompleted
Azienda Ospedaliera dei Colli
Coordinator of this site? Confirm its status
NaplesItalyCompleted
I.F.O. Istituti Fisioterapici Ospitalieri
Coordinator of this site? Confirm its status
RomeItalyCompleted
National Hospital Organization Kyushu Medical Center ( Site 3013)
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Kansai Medical University Hospital ( Site 3009)
Coordinator of this site? Confirm its status
HirakataJapanUnknown status
Kanazawa University Hospital ( Site 3006)
Coordinator of this site? Confirm its status
KanazawaJapanUnknown status
National Cancer Center Hospital East ( Site 3002)
Coordinator of this site? Confirm its status
KashiwaJapanUnknown status
Cancer Institute Hospital of JFCR ( Site 3003)
Coordinator of this site? Confirm its status
KotoJapanUnknown status
Kurume University Hospital ( Site 3014)
Coordinator of this site? Confirm its status
KurumeJapanUnknown status
National Hospital Organization Shikoku Cancer Center ( Site 3012)
Coordinator of this site? Confirm its status
MatsuyamaJapanUnknown status
Aichi Cancer Center ( Site 3016)
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Shizuoka Cancer Center ( Site 3007)
Coordinator of this site? Confirm its status
NakatogariJapanUnknown status
Niigata Cancer Center Hospital ( Site 3005)
Coordinator of this site? Confirm its status
NiigataJapanUnknown status
Okayama University Hospital ( Site 3011)
Coordinator of this site? Confirm its status
OkayamaJapanUnknown status
National Hospital Organization Hokkaido Cancer Center ( Site 3015)
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Sendai Kousei Hospital ( Site 3001)
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SendaiJapanUnknown status
Kanagawa Cancer Center ( Site 3004)
Coordinator of this site? Confirm its status
YokohamaJapanUnknown status
Chungnam national university hospital-Department of Internal Medicine ( Site 2802)
Coordinator of this site? Confirm its status
DaejeonSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)
Coordinator of this site? Confirm its status
DeaguSouth KoreaUnknown status
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)
Coordinator of this site? Confirm its status
HwasunSouth KoreaUnknown status
Korea University Guro Hospital-Internal Medicine ( Site 2803)
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Coordinator of this site? Confirm its status
KaunasLithuaniaActive, not recruiting
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Coordinator of this site? Confirm its status
VilniusLithuaniaActive, not recruiting
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
Coordinator of this site? Confirm its status
GuadalajaraMexicoUnknown status
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
Coordinator of this site? Confirm its status
GuadalajaraMexicoUnknown status
Arké SMO S.A. de C.V. ( Site 0401)
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status
iCan Oncology Center Centro Medico AVE ( Site 0406)
Coordinator of this site? Confirm its status
MonterreyMexicoUnknown status
Centro de Investigacion Clinica de Oaxaca ( Site 0410)
Coordinator of this site? Confirm its status
Oaxaca CityMexicoUnknown status
Medisch Centrum Leeuwarden B.V.
Coordinator of this site? Confirm its status
LeeuwardenNetherlandsCompleted
University Hospital Maastricht
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MaastrichtNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsCompleted
Jeroen Bosch Ziekenhuis
Coordinator of this site? Confirm its status
's-HertogenboschNetherlandsCompleted
Isala Klinieken Stichting
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ZwolleNetherlandsCompleted
Przychodnia Lekarska "KOMED"
Coordinator of this site? Confirm its status
KoninPolandCompleted
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Coordinator of this site? Confirm its status
PeremyshlPolandCompleted
Med Polonia Sp z o.o.
Coordinator of this site? Confirm its status
PoznanPolandCompleted
Szpital Specjalistyczny w Prabutach Sp. z o.o.
Coordinator of this site? Confirm its status
PrabutyPolandCompleted
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Coordinator of this site? Confirm its status
SiedlcePolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Centrum Pulmonologii I Torakochirurgii W Bystrej
Coordinator of this site? Confirm its status
WilkowicePolandCompleted
Hospital Cuf Descobertas S.A.
Coordinator of this site? Confirm its status
LisbonPortugalCompleted
Champalimaud Clinical Centre
Coordinator of this site? Confirm its status
LisbonPortugalCompleted
Centro Hospitalar Universitario Do Porto E.P.E.
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PortoPortugalCompleted
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalCompleted
Medeuropa S.R.L.
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
Coordinator of this site? Confirm its status
CraiovaRomaniaActive, not recruiting
Blue Ridge Cancer Care ( Site 0015)
Coordinator of this site? Confirm its status
BlacksburgUnited StatesUnknown status
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
Coordinator of this site? Confirm its status
Boca RatonUnited StatesUnknown status
Dana-Farber Cancer Institute ( Site 0018)
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
University of Virginia Cancer Center ( Site 0019)
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology ( Site 0013)
Coordinator of this site? Confirm its status
Fort WayneUnited StatesUnknown status
Cancer and Hematology Centers of Western Michigan ( Site 0001)
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesUnknown status
Hattiesburg Clinic Hematology/Oncology ( Site 0003)
Coordinator of this site? Confirm its status
HattiesburgUnited StatesUnknown status
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
Coordinator of this site? Confirm its status
LancasterUnited StatesUnknown status
VA West Los Angeles Medical Center ( Site 0004)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Los Angeles Hematology Oncology Medical Group ( Site 0006)
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Los AngelesUnited StatesUnknown status
Infirmary Cancer Care ( Site 0022)
Coordinator of this site? Confirm its status
MobileUnited StatesUnknown status
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Unknown status
Hacettepe Universitesi-oncology hospital ( Site 2409)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital ( Site 2403)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)
Coordinator of this site? Confirm its status
BornovaTurkey (Türkiye)Unknown status
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)
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IstanbulTurkey (Türkiye)Unknown status
Medipol University Medical Faculty-oncology ( Site 2400)
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IstanbulTurkey (Türkiye)Unknown status
I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)
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IzmirTurkey (Türkiye)Unknown status

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This page is information, not medical advice. Discuss any trial with your doctor.