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
Sites (126)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Hospital Provincial del Centenario ( Site 0205) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Sanatorio Parque ( Site 0202) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| Krankenhaus Nord - Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Wiener Gesundheitsverbund Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Frankston Hospital-Oncology and Haematology ( Site 2702) Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Nepean Hospital ( Site 2700) Coordinator of this site? Confirm its status | Kingswood | Australia | Unknown status |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Calvary Mater Newcastle ( Site 2703) Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106) Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Lakeridge Health ( Site 0102) Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Peking Union Medical College Hospital ( Site 2921) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University ( Site 2914) Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Jilin Cancer Hospital-GCP office ( Site 2909) Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital ( Site 2907) Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital Sichuan University ( Site 2903) Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Cancer hospital. ( Site 2923) Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Provincial Cancer Hospital-oncology department ( Site 2904) Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Cancer Hospital-Oncology ( Site 2919) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital-oncology of department ( Site 2920) Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Cancer Hospital ( Site 2915) Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shanghai Chest Hospital-Oncology department ( Site 2900) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Fudan University Shanghai Cancer Center ( Site 2908) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Soochow University ( Site 2913) Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Hubei Cancer Hospital ( Site 2922) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910) Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Henan Cancer Hospital ( Site 2916) Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| SRH Wald-Klinikum Gera GmbH Coordinator of this site? Confirm its status | Gera | Germany | Completed |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Completed |
| Thoraxklinik At University Of Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Completed |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Vaasa Central Hospital Coordinator of this site? Confirm its status | Vaasa | Finland | Completed |
| Centre Hospitalier Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Heartlands Hospital-Oncology Research ( Site 2604) Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| The Christie-Clinical Research Facility ( Site 2607) Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Mount Vernon Hospital ( Site 2602) Coordinator of this site? Confirm its status | Northwood | United Kingdom | Unknown status |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Metropolitan Hospital Coordinator of this site? Confirm its status | Pireas | Greece | Completed |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Completed |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Completed |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Completed |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Completed |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Completed |
| Rambam Health Care Campus-Oncology ( Site 1301) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center-Oncology ( Site 1300) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center-ONCOLOGY ( Site 1302) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| National Hospital Organization Kyushu Medical Center ( Site 3013) Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kansai Medical University Hospital ( Site 3009) Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| Kanazawa University Hospital ( Site 3006) Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| National Cancer Center Hospital East ( Site 3002) Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Cancer Institute Hospital of JFCR ( Site 3003) Coordinator of this site? Confirm its status | Koto | Japan | Unknown status |
| Kurume University Hospital ( Site 3014) Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center ( Site 3012) Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Aichi Cancer Center ( Site 3016) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Shizuoka Cancer Center ( Site 3007) Coordinator of this site? Confirm its status | Nakatogari | Japan | Unknown status |
| Niigata Cancer Center Hospital ( Site 3005) Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Okayama University Hospital ( Site 3011) Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| National Hospital Organization Hokkaido Cancer Center ( Site 3015) Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Sendai Kousei Hospital ( Site 3001) Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Kanagawa Cancer Center ( Site 3004) Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Chungnam national university hospital-Department of Internal Medicine ( Site 2802) Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801) Coordinator of this site? Confirm its status | Deagu | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800) Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Korea University Guro Hospital-Internal Medicine ( Site 2803) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Coordinator of this site? Confirm its status | Kaunas | Lithuania | Active, not recruiting |
| Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras Coordinator of this site? Confirm its status | Vilnius | Lithuania | Active, not recruiting |
| Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407) Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403) Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Arké SMO S.A. de C.V. ( Site 0401) Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| iCan Oncology Center Centro Medico AVE ( Site 0406) Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Centro de Investigacion Clinica de Oaxaca ( Site 0410) Coordinator of this site? Confirm its status | Oaxaca City | Mexico | Unknown status |
| Medisch Centrum Leeuwarden B.V. Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Completed |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Completed |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Completed |
| Przychodnia Lekarska "KOMED" Coordinator of this site? Confirm its status | Konin | Poland | Completed |
| Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Coordinator of this site? Confirm its status | Peremyshl | Poland | Completed |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Szpital Specjalistyczny w Prabutach Sp. z o.o. Coordinator of this site? Confirm its status | Prabuty | Poland | Completed |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Centrum Pulmonologii I Torakochirurgii W Bystrej Coordinator of this site? Confirm its status | Wilkowice | Poland | Completed |
| Hospital Cuf Descobertas S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Champalimaud Clinical Centre Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Centro Hospitalar Universitario Do Porto E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| Medeuropa S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| Blue Ridge Cancer Care ( Site 0015) Coordinator of this site? Confirm its status | Blacksburg | United States | Unknown status |
| Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Dana-Farber Cancer Institute ( Site 0018) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Cancer Center ( Site 0019) Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology ( Site 0013) Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Cancer and Hematology Centers of Western Michigan ( Site 0001) Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Hattiesburg Clinic Hematology/Oncology ( Site 0003) Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| VA West Los Angeles Medical Center ( Site 0004) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Los Angeles Hematology Oncology Medical Group ( Site 0006) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Infirmary Cancer Care ( Site 0022) Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407) Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Hacettepe Universitesi-oncology hospital ( Site 2409) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent City Hospital ( Site 2403) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 2406) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402) Coordinator of this site? Confirm its status | Bornova | Turkey (Türkiye) | Unknown status |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Medipol University Medical Faculty-oncology ( Site 2400) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| I.E.U. Medical Point Hastanesi-Oncology ( Site 2408) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.