Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

January 16, 2026 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from pembrolizumab plus chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.

Study Type

Interventional

Enrollment (Actual)

739

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
      • La Rioja, Argentina, F5300COE
        • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, B1884BBF
        • Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
      • Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
        • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Sanatorio Parque ( Site 0205)
      • Rosario, Santa Fe Province, Argentina, 2002
        • Hospital Provincial del Centenario ( Site 0212)
  • Austria
      • Vienna, Austria, 1210
        • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
    • Styria
      • Graz, Styria, Austria, 8036
        • Medizinische Universität Graz ( Site 0704)
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medizinische Universitaet Innsbruck ( Site 0703)
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
      • Linz, Upper Austria, Austria, 4021
        • Kepler Universitätsklinikum ( Site 0707)
    • Vienna
      • Vienna, Vienna, Austria, 1140
        • Klinik Penzing-2. Lungenabteilung ( Site 0702)
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
      • São Paulo, Brazil, 01321-001
        • Hospital Paulistano ( Site 0401)
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Clínica de Oncologia Reichow ( Site 0407)
  • Chile
      • Antofagasta, Chile, 1240000
        • Centro de Investigación Oncológica del Norte ( Site 0504)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 6900941
        • FALP-UIDO ( Site 0505)
      • Santiago, Region M. de Santiago, Chile, 7560908
        • Centro de Oncología de Precisión ( Site 0515)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill ( Site 0510)
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • ONCOCENTRO APYS-ACEREY ( Site 0503)
    • Región de la Araucanía
      • Temuco, Región de la Araucanía, Chile, 4800827
        • James Lind Centro de Investigación del Cáncer ( Site 0502)
      • Temuco, Región de la Araucanía, Chile, 4810148
        • CIDO SpA-Oncology ( Site 0508)
    • Región del Biobío
      • Concepción, Región del Biobío, Chile, 4070196
        • Biocenter ( Site 0514)
  • China
    • Anhui
      • Hefei, Anhui, China, 230036
        • Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
      • Xiamen, Fujian, China, 361003
        • The First Affiliated hospital of Xiamen University ( Site 2626)
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital ( Site 2608)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University-Oncology department ( Site 2627)
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University ( Site 2623)
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 2622)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
    • Jilin
      • Changchun, Jilin, China, 132000
        • Jilin Cancer Hospital-oncology department ( Site 2603)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital-Oncology Department ( Site 2630)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center ( Site 2616)
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan Cancer hospital ( Site 2628)
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University ( Site 2610)
      • Yibin, Sichuan, China, 644000
        • The Second People's Hospital of Yibin ( Site 2629)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital-Oncology ( Site 2612)
      • Hangzhou, Zhejiang, China, 310052
        • The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050030
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110221
        • Administradora Country S.A. - Clinica del Country ( Site 0601)
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230001
        • Oncomedica S.A.-Oncomedica S.A ( Site 0609)
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Oncologos del Occidente ( Site 0608)
  • France
    • Centre-Val de Loire
      • Orléans, Centre-Val de Loire, France, 45067
        • CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
    • Haute-Savoie
      • Epagny Metz-Tessy, Haute-Savoie, France, 74370
        • Centre Hospitalier d'Annecy ( Site 0807)
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49055
        • Institut de Cancérologie de l'Ouest ( Site 0802)
    • Rhone
      • Lyon, Rhone, France, 69373
        • CENTRE LEON BERARD ( Site 0803)
    • Var
      • Toulon, Var, France, 83800 Cedex 9
        • HIA Sainte Anne ( Site 0804)
    • Vaucluse
      • Avignon, Vaucluse, France, 84000
        • Centre Hospitalier d'Avignon ( Site 0810)
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
    • Hesse
      • Giessen, Hesse, Germany, 35392
        • UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
    • North Rhine-Westphalia
      • Dortmund, North Rhine-Westphalia, Germany, 44263
        • GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • SRH Wald-Klinikum Gera ( Site 0911)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Oncology ( Site 1303)
      • Jerusalem, Israel, 9013102
        • Shaare Zedek Medical Center-Oncology ( Site 1306)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center-oncology ( Site 1301)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center-ONCOLOGY ( Site 1302)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center-Oncology ( Site 1305)
  • Japan
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center ( Site 2413)
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center ( Site 2412)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 2410)
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital ( Site 2404)
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center ( Site 2414)
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 2411)
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital ( Site 2407)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
    • Miyagi
      • Natori-shi, Miyagi, Japan, 981-1293
        • Miyagi Cancer Center ( Site 2401)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 2415)
    • Saitama
      • Ina-machi, Saitama, Japan, 362-0806
        • Saitama Prefectural Cancer Center ( Site 2406)
    • Shizuoka
      • Nakatogari, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center ( Site 2408)
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research ( Site 2402)
      • Shinagawa, Tokyo, Japan, 1428666
        • Showa University Hospital ( Site 2403)
  • Mexico
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25279
        • CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil Fray Antonio Alcalde ( Site 0307)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Arké SMO S.A. de C.V. ( Site 0301)
      • Mexico City, Mexico City, Mexico, 06760
        • Alivia Clínica de Alta Especialidad ( Site 0310)
  • Poland
    • Greater Poland Voivodeship
      • Konin, Greater Poland Voivodeship, Poland, 62-500
        • Przychodnia Lekarska KOMED ( Site 1902)
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • Med-Polonia Sp. z o. o. ( Site 1909)
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
      • Warsaw, Masovian Voivodeship, Poland, 04-125
        • Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)
    • Pomeranian Voivodeship
      • Prabuty, Pomeranian Voivodeship, Poland, 82-550
        • Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
    • Silesian Voivodeship
      • Bystra, Silesian Voivodeship, Poland, 43-360
        • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
  • South Korea
      • Seoul, South Korea
        • Korea University Guro Hospital-Internal Medicine ( Site 2204)
    • Jeonranamdo
      • Hwasun, Jeonranamdo, South Korea, 58128
        • Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
    • Pusan-Kwangyokshi
      • Busan, Pusan-Kwangyokshi, South Korea, 49241
        • Pusan National University Hospital ( Site 2205)
    • Seoul
      • Songpa-gu, Seoul, South Korea, 05505
        • Asan Medical Center ( Site 2206)
    • Taegu-Kwangyokshi
      • Deagu, Taegu-Kwangyokshi, South Korea, 41404
        • Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, South Korea, 35015
        • Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos-Oncology Department ( Site 1107)
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35001
        • Hospital Insular de Gran Canaria-Oncology ( Site 1102)
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 2253)
      • Tainan, Taiwan, 704
        • NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital-Oncology ( Site 2255)
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch ( Site 2251)
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital ( Site 2304)
      • Lak Si, Bangkok, Thailand, 10210
        • Chulabhorn Hospital ( Site 2305)
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Faculty of Medicine - Khon Kaen University ( Site 2303)
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Songklanagarind hospital ( Site 2302)
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universitesi-oncology hospital ( Site 1202)
      • Ankara, Turkey (Türkiye), 06680
        • Liv Hospital Ankara-Oncology ( Site 1205)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara City Hospital ( Site 1204)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University-Medical Oncology ( Site 1203)
      • Istanbul, Turkey (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
      • Istanbul, Turkey (Türkiye), 34766
        • Umraniye Training and Research Hospital-medical oncology ( Site 1206)
    • Istanbul
      • Üsküdar / Stanbul, Istanbul, Turkey (Türkiye), 34662
        • Acibadem Altunizade Hospital-Oncology ( Site 1207)
  • United Kingdom
    • England
      • Leicester, England, United Kingdom
        • Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
      • London, England, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)
      • London-Camden, London, City of, United Kingdom, NW1 2PG
        • University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • UCHealth Memorial Hospital-Heme Onc ( Site 0003)
      • Fort Collins, Colorado, United States, 80528
        • University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida ( Site 0022)
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital ( Site 0011)
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center ( Site 0015)
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists ( Site 0008)
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan ( Site 0002)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester, Minnesota ( Site 0030)
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University-Cancer Center ( Site 0013)
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Oncology ( Site 0019)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Cancer Center ( Site 0018)

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

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
  • Has not received prior systemic treatment for metastatic NSCLC
  • Has measurable disease based on RECIST 1.1, as determined by the local site assessment
  • Has a life expectancy of at least 3 months
  • Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method

Exclusion Criteria:

  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
  • Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus
  • Received prior systemic anticancer therapy for metastatic disease
  • Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
  • History of allogeneic tissue/solid organ transplant
  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation
  • Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-7684A + Chemotherapy
Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Biological: Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations
Other Names:
  • MK-7684A
Drug: Carboplatin
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
Other Names:
  • PARAPLATIN®, Paraplatin NovaPlus ®
Drug: Cisplatin
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
Other Names:
  • Platinol-AQ®
Drug: Paclitaxel
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
Other Names:
  • TAXOL®, ONXOL®
Drug: Nab-paclitaxel
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
Other Names:
  • ABRAXANE®
Drug: Pemetrexed
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
Other Names:
  • Alimta®
Active Comparator: Pembrolizumab + Chemotherapy
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Drug: Carboplatin
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
Other Names:
  • PARAPLATIN®, Paraplatin NovaPlus ®
Drug: Cisplatin
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
Other Names:
  • Platinol-AQ®
Drug: Paclitaxel
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
Other Names:
  • TAXOL®, ONXOL®
Drug: Nab-paclitaxel
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
Other Names:
  • ABRAXANE®
Drug: Pemetrexed
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
Other Names:
  • Alimta®
Biological: Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations
Other Names:
  • MK-3475, KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Time Frame: Up to approximately 29 months
OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 29 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in All Participants
Time Frame: Up to approximately 29 months
OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all randomized participants. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 29 months
Progression-Free Survival (PFS)
Time Frame: Up to approximately 29 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) was planned to be presented.
Up to approximately 29 months
Objective Response Rate (ORR)
Time Frame: Up to approximately 29 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by blinded independent central review (BICR) was planned to be presented.
Up to approximately 29 months
Duration of Response (DOR)
Time Frame: Up to approximately 29 months
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR was planned to be presented.
Up to approximately 29 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 29 months
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 was planned to be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. 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 quality of life 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 29 months
Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time Frame: Baseline and Up to approximately 29 months
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (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 29 months
Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Time Frame: Baseline and up to approximately 29 months
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role 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 29 months
Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Time Frame: Baseline and Up to approximately 29 months
Change from baseline in the score of EORTC QLQ-C30 Item 8 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (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 29 months
Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
Time Frame: Baseline and Up to approximately 29 months
Change from baseline in the score of EORTC QLQ-LC13 Item 31 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (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 29 months
Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13
Time Frame: Baseline and Up to approximately 29 months
Change from baseline in the score of EORTC QLQ-LC13 Item 40 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (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 29 months
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
Time Frame: Up to approximately 29 months
TTD in the score of EORTC QLQ-C30 Items 29 and 30 was planned to be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. 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 quality of life 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.
Up to approximately 29 months
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30
Time Frame: Up to approximately 29 months
TTD in the score of EORTC QLQ-C30 Items 1-5 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (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.
Up to approximately 29 months
TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Time Frame: Up to approximately 29 months
TTD in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role 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.
Up to approximately 29 months
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Time Frame: Up to approximately 29 months
TTD in the score of EORTC QLQ-C30 Item 8 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (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.
Up to approximately 29 months
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
Time Frame: Up to approximately 29 months
TTD in the score of EORTC QLQ-LC13 Item 31 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (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.
Up to approximately 29 months
TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Time Frame: Up to approximately 29 months
TTD in the score of EORTC QLQ-LC13 Item 40 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (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.
Up to approximately 29 months
Number of Participants Who Experienced One or More Adverse Events (AEs)
Time Frame: Up to approximately 46 months
The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Up to approximately 46 months
Number of Participants Who Discontinued Study Intervention Due to an AE
Time Frame: Up to approximately 46 months
The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Up to approximately 46 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.

General Publications

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 (Actual)

September 24, 2024

Study Completion (Actual)

January 9, 2026

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-007
  • MK-7684A-007 (Other Identifier: MSD)
  • KEYVIBE-007 (Other Identifier: MSD)
  • jRCT2031220098 (Registry Identifier: jRCT)
  • U1111-1293-2114 (Registry Identifier: UTN)
  • 2023-506074-12-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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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