Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

February 3, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer

Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive.

  • Metastatic means cancer that has spread to other parts of the body.
  • PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system.

The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 05-Sep-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 58 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Study Type

Interventional

Enrollment (Actual)

1264

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

  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204)
      • São Paulo, Brazil, 01246-000
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200)
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60135-237
        • Hospital São Carlos-Oncocentro Ce ( Site 0208)
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201)
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88020-210
        • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209)
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • BC Cancer Victoria-Clinical Trials Unit ( Site 0107)
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102)
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health ( Site 0106)
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava
  • Chile
      • Antofagasta, Chile, 1240000
        • Bradford Hill Norte ( Site 0708)
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • IC La Serena Research ( Site 0710)
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5500243
        • Clínica Puerto Montt ( Site 0713)
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Oncocentro Valdivia ( Site 0715)
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0703)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500653
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)
      • Santiago, Region M. de Santiago, Chile, 7500713
        • Orlandi Oncologia ( Site 0700)
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP ( Site 0702)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill ( Site 0701)
    • Región de la Araucanía
      • Temuco, Región de la Araucanía, Chile, 4800827
        • James Lind Centro de Investigacion del Cancer ( Site 0711)
      • Temuco, Región de la Araucanía, Chile, 4810218
        • CIDO SpA-Oncology ( Site 0707)
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • The First Affiliated Hospital of Anhui Medical University ( Site 2022)
      • Hefei, Anhui, China, 230036
        • Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030)
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001)
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003)
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009)
      • Beijing, Beijing Municipality, China, 101149
        • Beijing Chest Hospital,Capital Medical University ( Site 2020)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing Cancer Hospital-Medical Oncology ( Site 2028)
      • Chongqing, Chongqing Municipality, China, 400042
        • Army Medical Center of People's Liberation Army-respiratory ( Site 2025)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospital-oncology department ( Site 2023)
      • Fuzhou, Fujian, China, 350025
        • Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029)
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital ( Site 2006)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital ( Site 2015)
    • Hubei
      • Wuhan, Hubei, China, 430010
        • Wuhan Union Hospital-Medical Oncology ( Site 2019)
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026)
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital-thoracic oncology II ( Site 2013)
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016)
    • Jilin
      • Changchun, Jilin, China, 132000
        • Jilin Cancer Hospital-oncology department ( Site 2000)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tang Du Hospital ( Site 2004)
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012)
    • Shandong
      • Linyi, Shandong, China, 276001
        • LinYi Cancer Hospital ( Site 2034)
      • Linyi, Shandong, China
        • Linyi People's Hospital-Oncology ( Site 2035)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center ( Site 2032)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital Sichuan University-respiratory ( Site 2018)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310052
        • The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
      • Hangzhou, Zhejiang, China, 310002
        • Hangzhou Cancer Hospital-Medical Oncology ( Site 2039)
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital-Breast Oncology ( Site 2008)
      • Linhai, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027)
      • Wenzhou, Zhejiang, China, 325015
        • The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031)
  • Dominican Republic
    • Nacional
      • Santo Domingo, Nacional, Dominican Republic, 10102
        • Instituto de Oncologia ( Site 2300)
      • Santo Domingo, Nacional, Dominican Republic, 10104
        • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301)
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Onco Go, S.A ( Site 0306)
      • Guatemala City, Guatemala, 01010
        • CELAN,S.A ( Site 0304)
      • Guatemala City, Guatemala, 01010
        • Gastrosoluciones ( Site 0302)
      • Guatemala City, Guatemala, 01010
        • INTEGRA Cancer Institute ( Site 0303)
      • Guatemala City, Guatemala, 01010
        • Oncomedica-Guatemala ( Site 0301)
      • Guatemala City, Guatemala, 01015
        • Grupo Medico Angeles ( Site 3007)
  • Hong Kong
      • Central, Hong Kong, 0000
        • Hong Kong Integrated Oncology Centre ( Site 1301)
      • Hksar, Hong Kong
        • Queen Mary Hospital ( Site 1303)
      • Jordan, Hong Kong
        • Hong Kong United Oncology Centre ( Site 1302)
      • Lai Chi Kok, Hong Kong, 999007
        • Princess Margaret Hospital ( Site 1304)
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis University-Pulmonológiai Klinika ( Site 1209)
    • Bekes County
      • Gyula, Bekes County, Hungary, 5700
        • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207)
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201)
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205)
    • Heves County
      • Kékestető, Heves County, Hungary, 3233
        • Mátrai Gyógyintézet ( Site 1214)
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200)
    • Pest County
      • Budapest, Pest County, Hungary, 1121
        • Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204)
      • Törökbálint, Pest County, Hungary, 2045
        • Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208)
    • Zala County
      • Zalaegerszeg, Zala County, Hungary, 8900
        • Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202)
  • India
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Artemis hospital ( Site 2401)
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital-Medical Oncology ( Site 2404)
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • All India Institute of Medical Sciences ( Site 2403)
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute And Research Centre ( Site 2400)
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital-Medical Oncology ( Site 1926)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 1913)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 1915)
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital ( Site 1917)
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital ( Site 1902)
      • Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research ( Site 1901)
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital ( Site 1910)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 1920)
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University ( Site 1906)
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 1911)
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 1912)
    • Gunma
      • Otashi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center ( Site 1925)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center ( Site 1923)
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922)
      • Takarazuka, Hyōgo, Japan, 665-0827
        • Takarazuka City Hospital ( Site 1924)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center ( Site 1921)
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa cancer center ( Site 1916)
    • Miyagi
      • Sendai, Miyagi, Japan, 981-0914
        • Sendai Kousei Hospital ( Site 1900)
    • Niigata
      • Niigata, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 1904)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital ( Site 1914)
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit
      • Takatsuki, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital ( Site 1908)
      • Ōsaka-sayama, Osaka, Japan, 589-8511
        • Kindai University Hospital- Osakasayama Campus ( Site 1907)
    • Shizuoka
      • Nakatogari, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center ( Site 1905)
    • Tochigi
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center ( Site 1927)
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre ( Site 1504)
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan ( Site 1502)
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10050
        • Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503)
      • George Town, Pulau Pinang, Malaysia, 10450
        • Hospital Pulau Pinang ( Site 1501)
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • National Cancer Institute ( Site 1505)
  • Mexico
      • Chihuahua City, Mexico, 31217
        • Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402)
      • Mexico City, Mexico, 14050
        • Human Science Research Trials ( Site 0406)
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization ( Site 0403)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44680
        • Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06700
        • Arké SMO S.A. de C.V. ( Site 0417)
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Centro de Investigacion Clinica Chapultepec ( Site 0400)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64710
        • iCan Oncology Center Centro Medico AVE ( Site 0405)
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76000
        • Hospital H+ Queretaro ( Site 0416)
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care and Research SA de CV ( Site 0409)
  • Peru
      • Lima, Peru, 15001
        • Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508)
      • Lima, Peru, 15036
        • Clínica Internacional - Sede San Borja ( Site 0506)
      • Lima, Peru, 15038
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500)
      • Lima, Peru, 15076
        • Hospital Militar Central Luis Arias Schereiber ( Site 0502)
    • Lima region
      • San Isidro, Lima region, Peru, 15024
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507)
    • Qusqu
      • Cusco, Qusqu, Peru, CUSCO 84
        • UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504)
  • Philippines
    • National Capital Region
      • Quezon City, National Capital Region, Philippines, 1100
        • East Avenue Medical Center-Department of Medicine ( Site 1605)
      • Quezon City, National Capital Region, Philippines, 1100
        • Veterans Memorial Medical Center-Section of Oncology ( Site 1608)
      • San Juan City, Metro Manila, National Capital Region, Philippines, 1502
        • CARDINAL SANTOS MEDICAL CENTER ( Site 1606)
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Cardiomed SRL Cluj-Napoca ( Site 2201)
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202)
    • Prahova
      • Ploieşti, Prahova, Romania, 100010
        • SC Medical Center Gral SRL ( Site 2203)
  • Russia
      • Saint Petersburg, Russia, 197758
        • Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803)
    • Moscow
      • Moscow, Moscow, Russia, 121359
        • Central Clinical Hospital of the Presidential Administrative Department ( Site 0802)
    • Moscow Oblast
      • Balashikha, Moscow Oblast, Russia, 143900
        • Moscow Regional Oncological Dispensary ( Site 0812)
      • Moscow, Moscow Oblast, Russia, 121205
        • Hadassah Medical-Oncology department ( Site 0814)
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603081
        • Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 194291
        • GBUZ LOKB-Oncology department #1 ( Site 0804)
    • Tatarstan, Respublika
      • Kazan', Tatarstan, Respublika, Russia, 420029
        • Republican Clinical Oncology Dispensary ( Site 0805)
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research ( Site 0900)
      • Johannesburg, Gauteng, South Africa, 2196
        • Medical Oncology Centre of Rosebank ( Site 0906)
      • Pretoria, Gauteng, South Africa, 0181
        • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901)
      • Sandton, Gauteng, South Africa, 2196
        • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902)
      • Soweto, Gauteng, South Africa, 2013
        • Wits Clinical Research-Wits Clinical Research Bara ( Site 0908)
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • The Oncology Centre ( Site 0905)
      • Richards Bay, KwaZulu-Natal, South Africa, 3900
        • Abraham Oncology ( Site 0907)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials ( Site 0903)
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 1401)
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital ( Site 1409)
      • Seoul, South Korea, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410)
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System ( Site 1402)
      • Seoul, South Korea, 05505
        • Asan Medical Center ( Site 1400)
      • Seoul, South Korea, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • National Cancer Center-Lung Cancer Center ( Site 1407)
      • Seongnam, Kyonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital ( Site 1403)
      • Suwon, Kyonggi-do, South Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405)
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital-Internal medicine ( Site 1406)
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10330
        • Chulalongkorn University ( Site 1802)
      • Bangkok, Bangkok, Thailand, 10400
        • Ramathibodi Clinical Research Centre ( Site 1801)
      • Bangkok, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital ( Site 1800)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universitesi-oncology hospital ( Site 1001)
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 1002)
      • Ankara, Turkey (Türkiye), 06560
        • Gazi Universitesi-Oncology ( Site 1003)
      • Istanbul, Turkey (Türkiye), 34457
        • Acıbadem Maslak Hastanesi ( Site 1008)
      • Istanbul, Turkey (Türkiye), 34668
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000)
      • Samsun, Turkey (Türkiye), 55200
        • Samsun Medical Park Hastanesi-medical oncology ( Site 1005)
    • Kayseri
      • Talas, Kayseri, Turkey (Türkiye), 38039
        • Erciyes University Medical Oncology Department ( Site 1007)
  • Ukraine
    • Cherkasy Oblast
      • Cherkassy, Cherkasy Oblast, Ukraine, 18009
        • Cherkasy Regional Oncology Dispensary ( Site 1110)
    • Chernihiv Oblast
      • Chernihiv, Chernihiv Oblast, Ukraine, 14029
        • Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113)
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49102
        • Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100)
      • Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50048
        • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104)
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61103
        • Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • National Cancer Institute ( Site 1114)
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
        • Vinnytsia Regional Clinical Oncological Hospital ( Site 1102)
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
        • Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120)
    • Zaporizhzhia Oblast
      • Zaporizhzhia, Zaporizhzhia Oblast, Ukraine, 69059
        • Oncolife LLC-day-stay department ( Site 1107)
    • Zhytomyr Oblast
      • Zhytomyr, Zhytomyr Oblast, Ukraine, 10002
        • Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103)
  • United States
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital ( Site 0004)
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care ( Site 0026)
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Mercy Research - Cancer and Hematology Center ( Site 0032)
      • St Louis, Missouri, United States, 63141
        • Mercy Research - David C. Pratt Cancer Center ( Site 0025)
    • New York
      • Mineola, New York, United States, 11501
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center ( Site 0013)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center-Hematology/Oncology ( Site 0030)
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700 000
        • Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 2505)
      • Ho Chi Minh City, Vietnam, 700000
        • HCMC University Medical Center-Chemotherapy Department ( Site 2501)
    • Hanoi
      • Hanoi, Hanoi, Vietnam, 100000
        • Hanoi Oncology Hospital ( Site 2502)
      • Hanoi, Hanoi, Vietnam, 100000
        • K Hospital - National Cancer Hospital ( Site 2506)
      • Hanoi, Hanoi, Vietnam, 100000
        • National Lung Hospital-Oncology Department ( Site 2503)

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 a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
  • Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
  • Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
  • Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
  • Has a life expectancy of at least 3 months

  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

    • Is not a woman of childbearing potential (WOCBP)
    • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
  • Has adequate organ function

Exclusion Criteria:

  • Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy

  • Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.

    • Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
    • Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
  • Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
  • Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
  • Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease

  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.

    • Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.
    • Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
  • Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
  • Has an 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.
  • Has a 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 prior to the first dose of study intervention
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab/Vibostolimab
Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year).
Biological: Pembrolizumab/Vibostolimab
Coformulation of pembrolizumab (MK-3475) 200mg and vibostolimab (MK-7684) 200mg. Participants receive the coformulation by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years).
Other Names:
  • MK-7684A
Active Comparator: Pembrolizumab
Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received second course of treatment based on original randomization assignment for up to 17 cycles (up to ~1 year).
Biological: Pembrolizumab
Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to ~2 years).
Other Names:
  • Keytruda
  • MK-3475

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Participants With PD-L1 TPS ≥50%
Time Frame: Up to ~39 months
OS was defined as the time from randomization to death due to any cause.
Up to ~39 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~39 months
OS was defined as the time from randomization to death due to any cause.
Up to ~39 months
OS in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~39 months
OS was defined as the time from randomization to death due to any cause.
Up to ~39 months
Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~56 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. Per Response Evaluation Criteria in Solid Tumors (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 will be presented.
Up to ~56 months
PFS in Participants With PD-L1 TPS ≥50%
Time Frame: Up to ~56 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. Per Response Evaluation Criteria in Solid Tumors (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 will be presented.
Up to ~56 months
PFS in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~56 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. Per Response Evaluation Criteria in Solid Tumors (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 will be presented.
Up to ~56 months
Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~56 months
ORR is defined as 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) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Up to ~56 months
ORR in Participants With PD-L1 TPS ≥50%
Time Frame: Up to ~56 months
ORR is defined as 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) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Up to ~56 months
ORR in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~56 months
ORR is defined as 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) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Up to ~56 months
Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%
Time Frame: Up to ~56 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 blinded independent central review will be presented.
Up to ~56 months
DOR in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~56 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 blinded independent central review will be presented.
Up to ~56 months
DOR in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~56 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 blinded independent central review will be presented.
Up to ~56 months
Change From Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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 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 ~56 months
Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
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 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 ~56 months
Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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 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 ~56 months
Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
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 ~56 months
Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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 ~56 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) in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will 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 ~56 months
Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will 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 ~56 months
Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
Change from baseline in the score of EORTC QLQ-LC13 Item 31 will 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 ~56 months
Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will 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 ~56 months
Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will 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 ~56 months
Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
Change from baseline in the score of EORTC QLQ-LC13 Item 40 will 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 ~56 months
Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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 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.
Baseline and up to ~56 months
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
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 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.
Baseline and up to ~56 months
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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 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.
Baseline and up to ~56 months
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
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.
Baseline and up to ~56 months
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
TTD in the score of EORTC QLQ-LC13 Item 31 will 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.
Baseline and up to ~56 months
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
TTD in the score of EORTC QLQ-LC13 Item 31 will 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.
Baseline and up to ~56 months
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
TTD in the score of EORTC QLQ-LC13 Item 31 will 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.
Baseline and up to ~56 months
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~56 months
TTD in the score of EORTC QLQ-LC13 Item 40 will 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.
Baseline and up to ~56 months
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
Time Frame: Baseline and up to ~56 months
TTD in the score of EORTC QLQ-LC13 Item 40 will 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.
Baseline and up to ~56 months
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~56 months
TTD in the score of EORTC QLQ-LC13 Item 40 will 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.
Baseline and up to ~56 months
Number of Participants Who Experienced One or More Adverse Events (AEs)
Time Frame: Up to ~56 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 ~56 months
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Time Frame: Up to ~56 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 ~56 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)

April 7, 2021

Primary Completion (Actual)

September 5, 2024

Study Completion (Actual)

January 27, 2026

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-003
  • MK-7684A-003 (Other Identifier: MSD)
  • jRCT2021210025 (Registry Identifier: jRCT)
  • KEYVIBE-003 (Other Identifier: MSD)
  • 2020-004049-35 (EudraCT Number)
  • PHRR230831-006054 (Registry Identifier: PHRR)
  • U1111-1291-5552 (Registry Identifier: UTN)
  • 2023-505362-28-00 (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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