Clinical TrialID 7431

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

Small Cell Lung Carcinoma

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Clinical Trial Id: 7431
Evidence Id: 7431
Core Evidence Id: 7431
Source Clinical Trial Id: 7427
Herb2 Clinical Trial Id: HBCT007427
Nct Id: NCT05224141
Title: 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)
Status: Active_Not_Recruiting
Phase: Phase 3
Study Result: No
Study Condition: Small Cell Lung Carcinoma
Study Type: Interventional
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention: BIOLOGICAL: Pembrolizumab/Vibostolimab Co-Formulation|DRUG: Saline placebo|DRUG: Etoposide|DRUG: Cisplatin|BIOLOGICAL: Atezolizumab|DRUG: Carboplatin
Intervention Allocation: Randomized
Intervention Model: Parallel
Intervention Mask: Double
Intervention Purpose: Treatment
Gender: All
Age: Adult, Older_Adult
Enrollment: 450
Outcome Measure: Overall Survival (OS), Overall Survival (OS) is the time from randomization to the date of death due to any cause., Up to approximately 37 months
Sponsor Collaborator: Merck Sharp & Dohme LLC
Funded By: INDUSTRY
Location: Infirmary Cancer Care ( Site 0022), Mobile, Alabama, 36652, United States|Los Angeles Hematology Oncology Medical Group ( Site 0006), Los Angeles, California, 90017, United States|VA West Los Angeles Medical Center ( Site 0004), Los Angeles, California, 90073, United States|Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014), Boca Raton, Florida, 33486, United States|Fort Wayne Medical Oncology and Hematology ( Site 0013), Fort Wayne, Indiana, 46804, United States|Dana-Farber Cancer Institute ( Site 0018), Boston, Massachusetts, 02215, United States|Cancer and Hematology Centers of Western Michigan ( Site 0001), Grand Rapids, Michigan, 49503, United States|Hattiesburg Clinic Hematology/Oncology ( Site 0003), Hattiesburg, Mississippi, 39401, United States|Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005), Lancaster, Pennsylvania, 17601, United States|Blue Ridge Cancer Care ( Site 0015), Blacksburg, Virginia, 24060, United States|University of Virginia Cancer Center ( Site 0019), Charlottesville, Virginia, 22903, United States|Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201), Mar del Plata, Buenos Aires, 7600, Argentina|Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203), ABB, Caba, C1199ABB, Argentina|Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200), Buenos Aires, Caba, C1431FWO, Argentina|Sanatorio Parque ( Site 0202), Rosario, Santa Fe, 2000, Argentina|Hospital Provincial del Centenario ( Site 0205), Rosario, Santa Fe, 2002, Argentina|Nepean Hospital ( Site 2700), Penrith, New South Wales, 2747, Australia|Calvary Mater Newcastle ( Site 2703), Waratah, New South Wales, 2298, Australia|Frankston Hospital-Oncology and Haematology ( Site 2702), Frankston, Victoria, 3199, Australia|Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701), St Albans, Victoria, 3021, Australia|Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505), Linz, Oberosterreich, 4020, Austria|Kepler Universitätsklinikum ( Site 0507), Linz, Oberosterreich, 4021, Austria|Medizinische Universität Graz ( Site 0504), Graz, Steiermark, 8036, Austria|Klinik Penzing-2. Lungenabteilung ( Site 0502), Vienna, Wien, 1140, Austria|Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501), Wien, 1210, Austria|Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106), Kingston, Ontario, K7L 2V7, Canada|Lakeridge Health ( Site 0102), Oshawa, Ontario, L1G 2B9, Canada|Anhui Cancer Hospital ( Site 2915), Hefei, Anhui, 230031, China|Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901), Beijing, Beijing, 100142, China|Beijing Peking Union Medical College Hospital ( Site 2921), Beijing, Beijing, 100730, China|Fujian Provincial Cancer Hospital-oncology department ( Site 2904), Fuzhou, Fujian, 350014, China|Harbin Medical University Cancer Hospital-oncology of department ( Site 2920), Harbin, Heilongjiang, 150081, China|Henan Cancer Hospital ( Site 2916), Zhengzhou, Henan, 450008, China|Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912), Wuhan, Hubei, 430022, China|Hubei Cancer Hospital ( Site 2922), Wuhan, Hubei, 430079, China|Hunan Cancer Hospital ( Site 2907), Changsha, Hunan, 410013, China|The First Affiliated Hospital of Soochow University ( Site 2913), Suzhou, Jiangsu, 215006, China|Jilin Cancer Hospital-GCP office ( Site 2909), Changchun, Jilin, 130000, China|The First Hospital of Jilin University ( Site 2914), Changchun, Jilin, 130021, China|The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910), Xi'an, Shaanxi, 710061, China|Shanghai Chest Hospital-Oncology department ( Site 2900), Shanghai, Shanghai, 200030, China|Fudan University Shanghai Cancer Center ( Site 2908), Shanghai, Shanghai, 200032, China|Sichuan Cancer hospital ( Site 2923), Chengdu, Sichuan, 610041, China|West China Hospital Sichuan University ( Site 2903), Chengdu, Sichuan, 611135, China|Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906), Hangzhou, Zhejiang, 310016, China|Zhejiang Cancer Hospital-Oncology ( Site 2919), Hangzhou, Zhejiang, 310022, China|Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700), Vaasa, Pohjanmaa, 65130, Finland|Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702), Oulu, Pohjois-Pohjanmaa, 90220, Finland|Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701), Turku, Varsinais-Suomi, 20521, Finland|Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805), Marseille, Bouches-du-Rhone, 13915, France|CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800), Toulouse, Haute-Garonne, 31059, France|Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané, Limoges, Haute-Vienne, 87042, France|Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905), Heidelberg, Baden-Wurttemberg, 69126, Germany|Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907), Immenhausen, Hessen, 34376, Germany|Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901), Hannover, Niedersachsen, 30625, Germany|LungenClinic Grosshansdorf-Onkologie ( Site 0903), Grosshansdorf, Schleswig-Holstein, 22927, Germany|SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900), Gera, Thuringen, 07548, Germany|Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002), Athens, Attiki, 115 26, Greece|Sotiria Thoracic Diseases Hospital of Athens ( Site 1003), Athens, Attiki, 11527, Greece|Metropolitan Hospital ( Site 1001), Athens, Attiki, 185 47, Greece|University General Hospital of Heraklion ( Site 1004), Heraklion, Irakleio, 711 10, Greece|European Interbalkan Medical Center ( Site 1000), Thessaloniki, 570 01, Greece|Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105), Kecskemét, Bacs-Kiskun, 6000, Hungary|Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102), Gyor, Gyor-Moson-Sopron, 9024, Hungary|Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101), Törökbálint, Pest, 2045, Hungary|Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104), Kaposvár, Somogy, 7400, Hungary|St. James's Hospital ( Site 1200), Dublin, D08 E9P6, Ireland|Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201), Dublin, Dublin 9, Ireland|Rambam Health Care Campus-Oncology ( Site 1301), Haifa, 3109601, Israel|Shaare Zedek Medical Center-Oncology ( Site 1300), Jerusalem, 9103102, Israel|Sheba Medical Center-ONCOLOGY ( Site 1302), Ramat Gan, 5265601, Israel|Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402), Naples, Campania, 80131, Italy|Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401), Milan, Lombardia, 20133, Italy|Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403), Rozzano, Milano, 20089, Italy|Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400), Rome, Roma, 00144, Italy|Aichi Cancer Center Hospital ( Site 3016), Nagoya, Aichi, 464-8681, Japan|National Cancer Center Hospital East ( Site 3002), Kashiwa, Chiba, 277-8577, Japan|National Hospital Organization Shikoku Cancer Center ( Site 3012), Matsuyama, Ehime, 791-0280, Japan|Kurume University Hospital ( Site 3014), Kurume, Fukuoka, 830-0011, Japan|National Hospital Organization Hokkaido Cancer Center ( Site 3015), Sapporo, Hokkaido, 003-0804, Japan|Kanazawa University Hospital ( Site 3006), Kanazawa, Ishikawa, 920-8641, Japan|Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004), Yokohama, Kanagawa, 241-8515, Japan|Sendai Kousei Hospital ( Site 3001), Sendai, Miyagi, 9800873, Japan|Niigata Cancer Center Hospital ( Site 3005), Niigata-shi, Niigata, 951-8566, Japan|Kansai Medical University Hospital ( Site 3009), Hirakata, Osaka, 573-1191, Japan|Shizuoka Cancer Center ( Site 3007), Nagaizumi, Shizuoka, 411-8777, Japan|Japanese Foundation for Cancer Research ( Site 3003), Koto, Tokyo, 135-8550, Japan|National Hospital Organization Kyushu Medical Center ( Site 3013), Fukuoka, 810-8563, Japan|Okayama University Hospital ( Site 3011), Okayama, 700-8558, Japan|Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800), Hwasun, Jeonranamdo, 58128, Korea, Republic of|Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801), Deagu, Taegu-Kwangyokshi, 41404, Korea, Republic of|Chungnam national university hospital-Department of Internal Medicine ( Site 2802), Daejeon, Taejon-Kwangyokshi, 35015, Korea, Republic of|Korea University Guro Hospital-Internal Medicine ( Site 2803), Seoul, Korea, Republic of|Klaipeda University Hospital-Oncology chemotherapy ( Site 1502), Klaipeda, Klaipedos Miestas, 92288, Lithuania|National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501), Vilnius, Vilniaus Miestas, 08406, Lithuania|Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500), Kaunas, LT-50161, Lithuania|Arké SMO S.A. de C.V. ( Site 0401), Mexico, Distrito Federal, 06700, Mexico|Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407), Guadalajara, Jalisco, 44280, Mexico|Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403), Guadalajara, Jalisco, 44680, Mexico|iCan Oncology Center Centro Medico AVE ( Site 0406), Monterrey, Nuevo Leon, 64710, Mexico|Centro de Investigacion Clinica de Oaxaca ( Site 0410), Oaxaca, 68020, Mexico|Medische Centrum Leeuwarden ( Site 1619), Leeuwarden, Fryslan, 8934 AD, Netherlands|Ziekenhuis Rijnstate ( Site 1606), Arnhem, Gelderland, 6815 AD, Netherlands|Maastricht UMC+-Pulmonary disease ( Site 1602), Maastricht, Limburg, 6229 HX, Netherlands|Jeroen Bosch Hospital-Pulmonology ( Site 1605), Den Bosch, Noord-Brabant, 5223 GZ, Netherlands|Isala, locatie Zwolle-Poli Longziekten ( Site 1612), Zwolle, Overijssel, 8025 AB, Netherlands|Erasmus Medisch Centrum ( Site 1621), Rotterdam, Zuid-Holland, 3015 GD, Netherlands|Martini Ziekenhuis ( Site 1618), Groningen, 9728 NT, Netherlands|Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709), Siedlce, Mazowieckie, 08-110, Poland|Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier, Warszawa, Mazowieckie, 02-781, Poland|Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703), Przemysl, Podkarpackie, 37-700, Poland|Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706), Prabuty, Pomorskie, 82-550, Poland|Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707), Bystra, Slaskie, 43-360, Poland|Przychodnia Lekarska KOMED ( Site 1701), Konin, Wielkopolskie, 62-500, Poland|Med-Polonia Sp. z o. o. ( Site 1710), Poznan, Wielkopolskie, 60-693, Poland|Champalimaud Foundation ( Site 1812), Lisbon, Lisboa, 1400-038, Portugal|Hospital CUF Descobertas ( Site 1815), Lisbon, Lisboa, 1998-018, Portugal|Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813), Porto, 4099-001, Portugal|Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810), Porto, 4200-072, Portugal|MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905), București, Bucuresti, 022343, Romania|Centrul medical Focus ( Site 1903), București, Bucuresti, 022548, Romania|Cardiomed SRL Cluj-Napoca ( Site 1900), Cluj-Napoca, Cluj, 400015, Romania|Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904), Craiova, Dolj, 200385, Romania|Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 1901), Craiova, Dolj, 200746, Romania|Cabinet Medical Oncomed ( Site 1902), Timișoara, Timis, 300239, Romania|Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102), Madrid, Madrid, Comunidad De, 28041, Spain|H.R.U Málaga - Hospital General-Oncology ( Site 2104), Málaga, Malaga, 29011, Spain|Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100), Barcelona, 08035, Spain|Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103), Sevilla, 41009, Spain|Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402), Bornova, Izmir, 35100, Turkey|I.E.U. Medical Point Hastanesi-Oncology ( Site 2408), Izmir, Karsiyaka, Izmir, 009035575, Turkey|Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407), Adana, 01250, Turkey|Hacettepe Universitesi-oncology hospital ( Site 2409), Ankara, 06230, Turkey|Memorial Ankara Hastanesi-Medical Oncology ( Site 2406), Ankara, 06520, Turkey|Ankara Bilkent City Hospital ( Site 2403), Ankara, 06800, Turkey|Medipol University Medical Faculty-oncology ( Site 2400), Istanbul, 34214, Turkey|TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401), Istanbul, 34722, Turkey|The Christie-Clinical Research Facility ( Site 2607), Manchester, England, M20 4bx, United Kingdom|Mount Vernon Hospital ( Site 2602), Northwood, Hillingdon, HA6 2RN, United Kingdom|Heartlands Hospital-Oncology Research ( Site 2604), Birmingham, B9 5SS, United Kingdom
Other Id: 7684A-008|MK-7684A-008|KEYVIBE-008|jRCT2021220008|2023-503517-30|U1111-1287-4436|2021-005034-42
Start Date: 2022-03-24
Primary Completion Date: 2025-05-08
Completion Date: 2027-06-07
First Posted: 2022-02-04
Results First Posted
Last Update Posted: 2024-05-08
Study Document
Study Url: https://clinicaltrials.gov/study/NCT05224141
Title Cn
Title En: 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)
Bilingual Status: semi_complete