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)

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

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 treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Non-Small Cell Lung Cancer
• Intervention / Treatment: Biological: Pembrolizumab/Vibostolimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed; Biological: Pembrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

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)
  • Caba
    • ABB, Caba, Argentina, C1199ABB
      • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
    • Buenos Aires, Caba, Argentina, C1431FWO
      • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Sanatorio Parque ( Site 0205)
    • Rosario, Santa Fe, Argentina, 2002
      • Hospital Provincial del Centenario ( Site 0212)
• Austria
  • Wien, Austria, 1210
    • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
  • Oberosterreich
    • Linz, Oberosterreich, Austria, 4020
      • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
    • Linz, Oberosterreich, Austria, 4021
      • Kepler Universitätsklinikum ( Site 0707)
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz ( Site 0704)
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medizinische Universitaet Innsbruck ( Site 0703)
  • Wien
    • Vienna, Wien, 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)
  • Sao 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)
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • James Lind Centro de Investigación del Cáncer ( Site 0502)
    • Temuco, Araucania, Chile, 4810148
      • CIDO SpA-Oncology ( Site 0508)
  • Biobio
    • Concepción, Biobio, Chile, 4070196
      • Biocenter ( Site 0514)
  • 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)
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • ONCOCENTRO APYS-ACEREY ( Site 0503)
• China
  • Anhui
    • Hefei, Anhui, China, 230036
      • Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
  • Beijing
    • Beijing, Beijing, 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 City, 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
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center ( Site 2616)
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
  • Sichuan
    • Cheng Du, Sichuan, China, 610041
      • West China Hospital of Sichuan University ( Site 2610)
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer hospital ( Site 2628)
    • Yibin, Sichuan, China, 644000
      • The Second People's Hospital of Yibin ( Site 2629)
  • Tianjin
    • Tianjin, Tianjin, 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
    • Medellin, Antioquia, Colombia, 050030
      • Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
  • Cesar
    • Valledupar, Cesar, Colombia, 200001
      • Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
  • Cordoba
    • Montería, Cordoba, Colombia, 230001
      • Oncomedica S.A.-Oncomedica S.A ( Site 0609)
  • Distrito Capital De Bogota
    • Bogotá, Distrito Capital De Bogota, Colombia, 110221
      • Administradora Country S.A. - Clinica del Country ( Site 0601)
  • Risaralda
    • Pereira, Risaralda, Colombia, 660001
      • Oncologos del Occidente ( Site 0608)
• France
  • Centre
    • Orléans, Centre, 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)
  • Maine-et-Loire
    • ANGERS cedex 02, Maine-et-Loire, France, 49055
      • Institut de Cancérologie de l'Ouest ( Site 0802)
  • Nord-Pas-de-Calais
    • Lille, Nord-Pas-de-Calais, France, 59037
      • Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
  • Rhone
    • Lyon CEDEX 08, 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
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
  • Nordrhein-Westfalen
    • Dortmund, Nordrhein-Westfalen, Germany, 44263
      • GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
  • Thuringen
    • Gera, Thuringen, 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)
    • Toon, Ehime, Japan, 791-0295
      • Ehime University Hospital ( Site 2411)
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
  • Ishikawa
    • Kanazawa, Ishikawa, 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, 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
    • Nagaizumi, 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)
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital-Internal Medicine ( Site 2204)
  • Jeonranamdo
    • Hwasun, Jeonranamdo, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
  • Pusan-Kwangyokshi
    • Busan, Pusan-Kwangyokshi, Korea, Republic of, 49241
      • Pusan National University Hospital ( Site 2205)
  • Seoul
    • Songpa-gu, Seoul, Korea, Republic of, 05505
      • Asan Medical Center ( Site 2206)
  • Taegu-Kwangyokshi
    • Deagu, Taegu-Kwangyokshi, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
  • Taejon-Kwangyokshi
    • Daejeon, Taejon-Kwangyokshi, Korea, Republic of, 35015
      • Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
• Mexico
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25279
      • CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
  • Distrito Federal
    • Ciudad de Mexico, Distrito Federal, Mexico, 06760
      • Alivia Clínica de Alta Especialidad ( Site 0310)
    • Mexico, Distrito Federal, Mexico, 06700
      • Arké SMO S.A. de C.V. ( Site 0301)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil Fray Antonio Alcalde ( Site 0307)
• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
      • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 04-125
      • Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
    • 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 1904)
  • Pomorskie
    • Prabuty, Pomorskie, Poland, 82-550
      • Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
  • Slaskie
    • Bystra, Slaskie, Poland, 43-360
      • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
  • Wielkopolskie
    • Konin, Wielkopolskie, Poland, 62-500
      • Przychodnia Lekarska KOMED ( Site 1902)
    • Poznan, Wielkopolskie, Poland, 60-693
      • Med-Polonia Sp. z o. o. ( Site 1909)
• 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)
  • Sevilla, 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, 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, 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)
  • Khon Kaen
    • Muang, Khon Kaen, Thailand, 40002
      • Faculty of Medicine - Khon Kaen University ( Site 2303)
  • Krung Thep Maha Nakhon
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital ( Site 2304)
    • Lak Si, Krung Thep Maha Nakhon, Thailand, 10210
      • Chulabhorn Hospital ( Site 2305)
  • Songkhla
    • Hatyai, Songkhla, Thailand, 90110
      • Songklanagarind hospital ( Site 2302)
• Turkey
  • Adana, Turkey, 01250
    • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi-oncology hospital ( Site 1202)
  • Ankara, Turkey, 06680
    • Liv Hospital Ankara-Oncology ( Site 1205)
  • Ankara, Turkey, 06800
    • Ankara City Hospital ( Site 1204)
  • Edirne, Turkey, 22030
    • Trakya University-Medical Oncology ( Site 1203)
  • Istanbul, Turkey, 34722
    • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
  • Istanbul, Turkey, 34766
    • Umraniye Training and Research Hospital-medical oncology ( Site 1206)
  • Istanbul
    • Üsküdar / Stanbul, Istanbul, Turkey, 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

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 vibostolimab, 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 (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed; 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 + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed; 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)	OS is defined as the time from randomization to the date of death due to any cause.	Up to approximately 40 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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 BICR will be presented.	Up to approximately 40 months
Progression-Free Survival (PFS)	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) will be presented.	Up to approximately 40 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)	Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will 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 40 months
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will 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 40 months
Change from Baseline for Role Functioning Combined (Items 6 and 7) Score on the EORTC QLQ-C30	Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will 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 40 months
Change from Baseline in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	Change from baseline in the score of EORTC QLQ-C30 Item 8 will 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 40 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)	Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 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 40 months
Change from Baseline in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	Change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. The EORTC QLQ-C13 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 40 months
Time to Deterioration (TTD) 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)	TTD in the score of EORTC QLQ-C30 Items 29 and 30 will 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 40 months
TTD in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	TTD in the score of EORTC QLQ-C30 Items 1-5 will 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 40 months
TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30	TTD in the score of EORTC QLQ-C30 Items 6-7 will 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.	Up to approximately 40 months
TTD in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	TTD in the score of EORTC QLQ-C30 Item 8 will 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 40 months
TTD in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	TTD in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 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 40 months
TTD in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	TTD in the score of EORTC QLQ-C13 Item 40 will be presented. The EORTC QLQ-C13 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 40 months
Number of Participants Who Experienced One or More Adverse Events (AEs)	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 40 months
Number of Participants Who Discontinued Study Intervention Due to an AE	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 40 months
Duration of Response (DOR)	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 blinded independent central review will be presented.	Up to approximately 40 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): November 10, 2025
• Study Completion (Estimated): September 27, 2027

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): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Carboplatin; Paclitaxel; Pembrolizumab; Albumin-Bound Paclitaxel; Pemetrexed
• Other Study ID Numbers: 7684A-007; MK-7684A-007 (Other Identifier: Merck); KEYVIBE-007 (Other Identifier: Merck); jRCT2031220098 (Registry Identifier: jRCT)

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