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)

October 5, 2023 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically or cytologically confirmed diagnosis of 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

Exclusion Criteria:

  • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
  • Has received prior treatment for Small Cell Lung Cancer (SCLC)
  • Is expected to require any other form of antineoplastic therapy for SCLC while on study
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab/Vibostolimab
Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), 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 Q3W 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.
Biological: Pembrolizumab/Vibostolimab Co-Formulation
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.
Other Names:
  • MK-7684A
Drug: Saline placebo
Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
Drug: Etoposide
Etoposide 100 mg/m^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
Drug: Cisplatin
Cisplatin 75 mg/m^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Other Names:
  • PLATINOL-AQ®
Drug: Carboplatin
Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Other Names:
  • PARAPLATIN®
Active Comparator: Atezolizumab
Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, 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 Q3W 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.
Drug: Saline placebo
Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
Drug: Etoposide
Etoposide 100 mg/m^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
Drug: Cisplatin
Cisplatin 75 mg/m^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Other Names:
  • PLATINOL-AQ®
Drug: Carboplatin
Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Other Names:
  • PARAPLATIN®
Biological: Atezolizumab
Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
Other Names:
  • TECENTRIQ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 37 months
Overall Survival (OS) is the time from randomization to the date of death due to any cause.
Up to approximately 37 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to approximately 26 months
Progression-Free Survival (PFS) is the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first.
Up to approximately 26 months
Objective Response Rate (ORR)
Time Frame: Up to approximately 37 months
Objective Response Rate (ORR) is the percentage of participants who have a Complete Response (CR) (disappearance of all target lesions) or a Partial Response (PR) (at least a 30% decrease in the sum of diameters of target lesions).
Up to approximately 37 months
Duration of Response (DOR)
Time Frame: Up to approximately 37 months
Duration of Response (DOR) is the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), until progressive disease (PD) or death.
Up to approximately 37 months
Percentage of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 60 months
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.
Up to approximately 60 months
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 60 months
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.
Up to approximately 60 months
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)
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
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)
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months
TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Time Frame: Baseline and up to approximately 37 months
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.
Baseline and up to approximately 37 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Estimated)

May 8, 2025

Study Completion (Estimated)

June 7, 2027

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-008
  • MK-7684A-008 (Other Identifier: Merck)
  • KEYVIBE-008 (Other Identifier: Merck)
  • jRCT2021220008 (Registry Identifier: jRCT)
  • 2021-005034-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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