AzTrials
AzTrials

Small Cell Lung CarcinomaPhase 3NCT05224141

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 testing Pembrolizumab/Vibostolimab Co-Formulation, Etoposide and Cisplatin in people with Small Cell Lung Carcinoma, run by Merck Sharp & Dohme LLC at 140 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Pembrolizumab/Vibostolimab Co-Formulation, Etoposide and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
140 sitesin 25 countries
Study dates
24 Mar 2022to 7 Jun 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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
  • 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
  • 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
  • Has symptomatic ascites or pleural effusion

Trial locations and contacts

140 sites in 25 countries.

140 sites in 25 countries

China19 sites

  • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)

    Beijing, Beijing Municipality, 100142

  • Beijing Peking Union Medical College Hospital ( Site 2921)

    Beijing, Beijing Municipality, 100730

  • Jilin Cancer Hospital-GCP office ( Site 2909)

    Changchun, Jilin, 130000

  • The First Hospital of Jilin University ( Site 2914)

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital ( Site 2907)

    Changsha, Hunan, 410013

  • Sichuan Cancer hospital. ( Site 2923)

    Chengdu, Sichuan, 610042

  • West China Hospital Sichuan University ( Site 2903)

    Chengdu, Sichuan, 611135

  • Fujian Provincial Cancer Hospital-oncology department ( Site 2904)

    Fuzhou, Fujian, 350014

  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital-Oncology ( Site 2919)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)

    Harbin, Heilongjiang, 150000

  • Anhui Cancer Hospital ( Site 2915)

    Hefei, Anhui, 230031

  • Shanghai Chest Hospital-Oncology department ( Site 2900)

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Shanghai Cancer Center ( Site 2908)

    Shanghai, Shanghai Municipality, 200032

  • The First Affiliated Hospital of Soochow University ( Site 2913)

    Suzhou, Jiangsu, 215006

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912)

    Wuhan, Hubei, 430048

  • Hubei Cancer Hospital ( Site 2922)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)

    Xi'an, Shaanxi, 710061

  • Henan Cancer Hospital ( Site 2916)

    Zhengzhou, Henan, 450008

Other trials in China

Japan14 sites

  • National Hospital Organization Kyushu Medical Center ( Site 3013)

    Fukuoka, 810-8563

  • Kansai Medical University Hospital ( Site 3009)

    Hirakata, Osaka, 573-1191

  • Kanazawa University Hospital ( Site 3006)

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East ( Site 3002)

    Kashiwa, Chiba, 277-8577

  • Cancer Institute Hospital of JFCR ( Site 3003)

    Koto, Tokyo, 135-8550

  • Kurume University Hospital ( Site 3014)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 3012)

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center ( Site 3016)

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center ( Site 3007)

    Nakatogari, Shizuoka, 411-8777

  • Niigata Cancer Center Hospital ( Site 3005)

    Niigata, Niigata, 951-8566

  • Okayama University Hospital ( Site 3011)

    Okayama, 700-8558

  • National Hospital Organization Hokkaido Cancer Center ( Site 3015)

    Sapporo, Hokkaido, 003-0804

  • Sendai Kousei Hospital ( Site 3001)

    Sendai, Miyagi, 981-0914

  • Kanagawa Cancer Center ( Site 3004)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States11 sites

  • Blue Ridge Cancer Care ( Site 0015)

    Blacksburg, Virginia, 24060

  • Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)

    Boca Raton, Florida, 33486

  • Dana-Farber Cancer Institute ( Site 0018)

    Boston, Massachusetts, 02215

  • University of Virginia Cancer Center ( Site 0019)

    Charlottesville, Virginia, 22903

  • Fort Wayne Medical Oncology and Hematology ( Site 0013)

    Fort Wayne, Indiana, 46804

  • Cancer and Hematology Centers of Western Michigan ( Site 0001)

    Grand Rapids, Michigan, 49503

  • Hattiesburg Clinic Hematology/Oncology ( Site 0003)

    Hattiesburg, Mississippi, 39401

  • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)

    Lancaster, Pennsylvania, 17601

  • Los Angeles Hematology Oncology Medical Group ( Site 0006)

    Los Angeles, California, 90017

  • VA West Los Angeles Medical Center ( Site 0004)

    Los Angeles, California, 90073

  • Infirmary Cancer Care ( Site 0022)

    Mobile, Alabama, 36607

Other trials in United States

Turkey (Türkiye)8 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)

    Adana, 01250

  • Hacettepe Universitesi-oncology hospital ( Site 2409)

    Ankara, 06230

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)

    Ankara, 06520

  • Ankara Bilkent City Hospital ( Site 2403)

    Ankara, 06800

  • Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)

    Bornova, İzmir, 35100

  • Medipol University Medical Faculty-oncology ( Site 2400)

    Istanbul, 34214

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)

    Istanbul, 34722

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)

    Izmir, 35575

Other trials in Turkey (Türkiye)

Netherlands7 sites

  • Jeroen Bosch Hospital-Pulmonology ( Site 1605)

    's-Hertogenbosch, North Brabant, 5223 GZ

  • Ziekenhuis Rijnstate ( Site 1606)

    Arnhem, Gelderland, 6815 AD

  • Martini Ziekenhuis ( Site 1618)

    Groningen, 9728 NT

  • Medische Centrum Leeuwarden ( Site 1619)

    Leeuwarden, Provincie Friesland, 8934 AD

  • Maastricht UMC+-Pulmonary disease ( Site 1602)

    Maastricht, Limburg, 6229 HX

  • Erasmus Medisch Centrum ( Site 1621)

    Rotterdam, South Holland, 3015 GD

  • Isala, locatie Zwolle-Poli Longziekten ( Site 1612)

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Poland7 sites

  • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)

    Bystra, Silesian Voivodeship, 43-360

  • Przychodnia Lekarska KOMED ( Site 1701)

    Konin, Greater Poland Voivodeship, 62-500

  • Med-Polonia Sp. z o. o. ( Site 1710)

    Poznan, Greater Poland Voivodeship, 60-693

  • Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)

    Prabuty, Pomeranian Voivodeship, 82-550

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)

    Przemyśl, Podkarpackie Voivodeship, 37-700

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)

    Siedlce, Masovian Voivodeship, 08-110

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1700)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Romania6 sites

  • MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)

    Bucharest, Bucharest, 022343

  • Centrul medical Focus ( Site 1903)

    Bucharest, Bucharest, 022548

  • Cardiomed SRL Cluj-Napoca ( Site 1900)

    Cluj-Napoca, Cluj, 400015

  • Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)

    Craiova, Dolj, 200385

  • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1901)

    Craiova, Dolj, 200746

  • Cabinet Medical Oncomed ( Site 1902)

    Timișoara, Timiș County, 300239

Other trials in Romania

Argentina5 sites

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

    Mar del Plata, Buenos Aires, B7600FZO

  • Hospital Provincial del Centenario ( Site 0205)

    Rosario, Santa Fe Province, 2002

  • Sanatorio Parque ( Site 0202)

    Rosario, Santa Fe Province, S2000DVC

Other trials in Argentina

Austria5 sites

  • Medizinische Universität Graz ( Site 0504)

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)

    Linz, Upper Austria, 4020

  • Kepler Universitätsklinikum ( Site 0507)

    Linz, Upper Austria, 4021

  • Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502)

    Vienna, 1140

  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)

    Vienna, 1210

Other trials in Austria

Germany5 sites

  • SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)

    Gera, Thuringia, 07548

  • LungenClinic Grosshansdorf-Onkologie ( Site 0903)

    Großhansdorf, Schleswig-Holstein, 22927

  • Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)

    Hanover, Lower Saxony, 30625

  • Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)

    Heidelberg, Baden-Wurttemberg, 69126

  • Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)

    Immenhausen, Hesse, 34376

Other trials in Germany

Greece5 sites

  • Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)

    Athens, Attica, 115 26

  • Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)

    Athens, Attica, 11527

  • Metropolitan Hospital ( Site 1001)

    Athens, Attica, 185 47

  • University General Hospital of Heraklion ( Site 1004)

    Heraklion, Irakleio, 71500

  • European Interbalkan Medical Center ( Site 1000)

    Thessaloniki, 570 01

Other trials in Greece

Mexico5 sites

  • Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)

    Guadalajara, Jalisco, 44280

  • Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)

    Guadalajara, Jalisco, 44680

  • Arké SMO S.A. de C.V. ( Site 0401)

    Mexico City, Mexico City, 06700

  • iCan Oncology Center Centro Medico AVE ( Site 0406)

    Monterrey, Nuevo León, 64710

  • Centro de Investigacion Clinica de Oaxaca ( Site 0410)

    Oaxaca City, 68020

Other trials in Mexico

Australia4 sites

  • Frankston Hospital-Oncology and Haematology ( Site 2702)

    Frankston, Victoria, 3199

  • Nepean Hospital ( Site 2700)

    Kingswood, New South Wales, 2747

  • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)

    Melbourne, Victoria, 3021

  • Calvary Mater Newcastle ( Site 2703)

    Waratah, New South Wales, 2298

Other trials in Australia

Hungary4 sites

  • Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)

    Győr, Győr-Moson-Sopron, 9024

  • Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)

    Kaposvár, Somogy County, 7400

  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)

    Kecskemét, Bács-Kiskun county, 6000

  • Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)

    Törökbálint, Pest County, 2045

Other trials in Hungary

Italy4 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)

    Milan, Lombardy, 20133

  • Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)

    Naples, Campania, 80131

  • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)

    Rome, Roma, 00144

  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)

    Rozzano, Milano, 20089

Other trials in Italy

Portugal4 sites

  • Champalimaud Foundation ( Site 1812)

    Lisbon, Lisbon District, 1400-038

  • Hospital CUF Descobertas ( Site 1815)

    Lisbon, Lisbon District, 1998-018

  • Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)

    Porto, 4099-001

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)

    Porto, 4200-072

Other trials in Portugal

South Korea4 sites

  • Chungnam national university hospital-Department of Internal Medicine ( Site 2802)

    Daejeon, Taejon-Kwangyokshi, 35015

  • Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)

    Deagu, Taegu-Kwangyokshi, 41404

  • Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)

    Hwasun, Jeonranamdo, 58128

  • Korea University Guro Hospital-Internal Medicine ( Site 2803)

    Seoul

Other trials in South Korea

Spain4 sites

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)

    Madrid, Madrid, Comunidad de, 28041

  • H.R.U Málaga - Hospital General-Oncology ( Site 2104)

    Málaga, Malaga, 29011

  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)

    Seville, 41009

Other trials in Spain

Finland3 sites

  • Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)

    Oulu, North Ostrobothnia, 90220

  • Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)

    Turku, Southwest Finland, 20520

  • Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)

    Vaasa, Pohjanmaa, 65130

Other trials in Finland

France3 sites

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 0803)

    Limoges, Haute-Vienne, 87042

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)

    Marseille, Bouches-du-Rhone, 13915

  • CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)

    Toulouse, Haute-Garonne, 31400

Other trials in France

Israel3 sites

  • Rambam Health Care Campus-Oncology ( Site 1301)

    Haifa, 3109601

  • Shaare Zedek Medical Center-Oncology ( Site 1300)

    Jerusalem, 9103102

  • Sheba Medical Center-ONCOLOGY ( Site 1302)

    Ramat Gan, 5265601

Other trials in Israel

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)

    Kaunas, LT-50161

  • Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)

    Klaipėda, Klaipedos Miestas, 92288

  • National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)

    Vilnius, Vilniaus Miestas, 08660

Other trials in Lithuania

United Kingdom3 sites

  • Heartlands Hospital-Oncology Research ( Site 2604)

    Birmingham, B9 5SS

  • The Christie-Clinical Research Facility ( Site 2607)

    Manchester, England, M20 4BX

  • Mount Vernon Hospital ( Site 2602)

    Northwood, Hillingdon, HA6 2RN

Other trials in United Kingdom

Canada2 sites

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)

    Kingston, Ontario, K7L 2V7

  • Lakeridge Health ( Site 0102)

    Oshawa, Ontario, L1G 2B9

Other trials in Canada

Ireland2 sites

  • St. James's Hospital ( Site 1200)

    Dublin, D08 E9P6

  • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)

    Dublin, Dublin 9

Other trials in Ireland

About this study

Official title: 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)

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.

Read the detailed description

With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported.

Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.

Being tested
Pembrolizumab/Vibostolimab Co-Formulation, Saline placebo, Etoposide, Cisplatin, Atezolizumab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab/Vibostolimab Co-FormulationBiological

    Also called MK-7684A

    Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

  • Saline placeboDrug

    Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

  • EtoposideDrug

    Etoposide 100 mg/m^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

  • CisplatinDrug

    Also called PLATINOL-AQ®

    Cisplatin 75 mg/m^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

  • AtezolizumabBiological

    Also called TECENTRIQ®

    Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

  • CarboplatinDrug

    Also called PARAPLATIN®

    Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Study groups in NCT05224141
Study groupRoleWhat they receive
Pembrolizumab/VibostolimabExperimentalParticipants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve [AUC] 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Receives: Biological: Pembrolizumab/Vibostolimab Co-Formulation; Drug: Saline placebo; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin
AtezolizumabActive comparatorParticipants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Receives: Drug: Saline placebo; Drug: Etoposide; Drug: Cisplatin; Biological: Atezolizumab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.

    Measured: Up to approximately 25 months

Secondary outcomes (15)

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.

    Measured: Up to approximately 25 months

  2. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen \& Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or > upper limit of normal [ULN]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No).

    Measured: Up to approximately 25 months

  3. Duration of Response (DOR)

    For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data.

    Measured: Up to approximately 25 months

  4. Percentage of Participants Who Experienced an Adverse Event (AE)

    An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Measured: Up to approximately 60 months

  5. Percentage of Participants Who Discontinued Study Treatment Due to an AE

    An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Measured: Up to approximately 60 months

  6. Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

    Measured: Baseline and up to approximately 60 months

  7. Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

    Measured: Baseline and up to approximately 60 months

  8. Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

    Measured: Baseline and up to approximately 60 months

  9. Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.

    Measured: Baseline and up to approximately 60 months

  10. Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

    Measured: Baseline and up to approximately 60 months

  11. Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Baseline and up to approximately 60 months

  12. TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Baseline and up to approximately 60 months

  13. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Baseline and up to approximately 60 months

  14. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13

    The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Baseline and up to approximately 60 months

  15. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

    Measured: Baseline and up to approximately 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start24 Mar 2022
  3. Primary completion4 Jun 2024
  4. Study completion7 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05224141
Sponsor's protocol ID
7684A-008
Other IDs
MK-7684A-008, KEYVIBE-008, jRCT2021220008, 2023-503517-30-00, U1111-1287-4436, 2021-005034-42, 2023
Status last verified
Jul 2025
First submitted
25 Jan 2022
Last updated
8 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Sands J, Lu S, Aerts JG, Reck M, Navarro A, Shentzer Kutiel T, Peled N, Casarini I, Kerr SJ, Takahashi T, Bilici A, Cheng Y, Wang M, Lee SY, Lowczak A, Mazieres J, Hu H, Wu J, Aggarwal H, El-Osta H, Paz-Ares L. Vibostolimab Coformulated with Pembrolizumab Plus Chemotherapy as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer. Target Oncol. 2026 Oct 20. doi: 10.1007/s11523-026-01237-w. Online ahead of print.

    PubMed 42900351

  • Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.

    PubMed 39230120

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab/Vibostolimab Co-Formulation, Etoposide and Cisplatin in people with Small Cell Lung Carcinoma, run by Merck Sharp & Dohme LLC at 140 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in China, Japan, United States, Turkey (Türkiye), Netherlands and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 25 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05224141, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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