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)

April 18, 2024 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

The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to (1) overall survival (OS) in participants with programmed cell death 1 ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%, TPS ≥1% and TPS 1% to 49%; and (2) progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR), in participants with PD-L1 TPS ≥1% and TPS ≥50%.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1246

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 Contact

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Recruiting
        • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 21 3207-6569
    • Ceara
      • Fortaleza, Ceara, Brazil, 60135-237
        • Recruiting
        • Hospital São Carlos-Oncocentro Ce ( Site 0208)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 853034-8677
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Recruiting
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 558440095595
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Recruiting
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: +555531950504
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050170
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân
        • Contact:
          • Study Coordinator
          • Phone Number: 555132148143
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88020-210
        • Recruiting
        • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209)
        • Contact:
          • Study Coordinator
          • Phone Number: 554833311553
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • Recruiting
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 11 3893-3530
      • São Paulo, Sao Paulo, Brazil, 04014-002
        • Recruiting
        • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: 551134744278
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • Recruiting
        • BC Cancer Victoria-Clinical Trials Unit ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 2505195572
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 9053879495
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 6135496666
      • Oshawa, Ontario, Canada, L1G 2B9
        • Recruiting
        • Lakeridge Health ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 9055768711
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Recruiting
        • Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava
        • Contact:
          • Study Coordinator
          • Phone Number: 450-668-1010 x23603
  • Chile
      • Antofagasta, Chile, 1240000
        • Recruiting
        • Bradford Hill Norte ( Site 0708)
        • Contact:
          • Study Coordinator
          • Phone Number: +56552654147
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Recruiting
        • James Lind Centro de Investigación del Cáncer ( Site 0711)
        • Contact:
          • Study Coordinator
          • Phone Number: +56452982404
      • Temuco, Araucania, Chile, 4810218
        • Recruiting
        • CIDO SpA-Oncology ( Site 0707)
        • Contact:
          • Study Coordinator
          • Phone Number: 569 5 798 31 73
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • Recruiting
        • IC La Serena Research ( Site 0710)
        • Contact:
          • Study Coordinator
          • Phone Number: +56512386127
    • Los Lagos
      • Puerto Montt, Los Lagos, Chile, 5500243
        • Recruiting
        • Clínica Puerto Montt ( Site 0713)
        • Contact:
          • Study Coordinator
          • Phone Number: +56998634501
    • Los Rios
      • Valdivia, Los Rios, Chile, 5112129
        • Recruiting
        • Oncocentro Valdivia ( Site 0715)
        • Contact:
          • Study Coordinator
          • Phone Number: +56232634933
    • Maule
      • Talca, Maule, Chile, 3465584
        • Recruiting
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: +56712635600
    • Region M. De Santiago
      • Providencia, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +56227067543
      • Santiago, Region M. De Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. De Santiago, Chile, 7500713
        • Recruiting
        • Orlandi Oncologia ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: 56992214787
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Active, not recruiting
        • The First Affiliated Hospital of Anhui Medical University ( Site 2022)
      • Hefei, Anhui, China, 230036
        • Active, not recruiting
        • Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017)
    • Beijing
      • Beijing, Beijing, China, 100021
        • Active, not recruiting
        • Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030)
      • Beijing, Beijing, China, 100142
        • Active, not recruiting
        • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001)
      • Beijing, Beijing, China, 100142
        • Active, not recruiting
        • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003)
      • Beijing, Beijing, China, 100730
        • Active, not recruiting
        • Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009)
      • Beijing, Beijing, China, 101149
        • Completed
        • Beijing Chest Hospital,Capital Medical University ( Site 2020)
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Active, not recruiting
        • Chongqing Cancer Hospital-Medical Oncology ( Site 2028)
      • Chongqing, Chongqing, China, 400042
        • Active, not recruiting
        • Army Medical Center of People's Liberation Army-respiratory ( Site 2025)
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Active, not recruiting
        • Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029)
      • Fuzhou, Fujian, China, 350014
        • Active, not recruiting
        • Fujian Provincial Cancer Hospital-oncology department ( Site 2023)
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Active, not recruiting
        • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Active, not recruiting
        • Harbin Medical University Cancer Hospital ( Site 2006)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Active, not recruiting
        • Henan Cancer Hospital ( Site 2015)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Active, not recruiting
        • Wuhan Union Hospital-Medical Oncology ( Site 2019)
    • Hunan
      • Changsha, Hunan, China, 410013
        • Active, not recruiting
        • Hunan Cancer Hospital-thoracic oncology II ( Site 2013)
      • Changsha, Hunan, China, 410008
        • Active, not recruiting
        • Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026)
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Active, not recruiting
        • Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016)
    • Jilin
      • Changchun, Jilin, China, 132000
        • Active, not recruiting
        • Jilin Cancer Hospital-oncology department ( Site 2000)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Active, not recruiting
        • The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012)
      • Xi'an, Shaanxi, China, 710038
        • Completed
        • Tang Du Hospital ( Site 2004)
    • Shandong
      • Linyi, Shandong, China, 276001
        • Active, not recruiting
        • LinYi Cancer Hospital ( Site 2034)
      • Linyi, Shandong, China
        • Completed
        • Linyi People's Hospital-Oncology ( Site 2035)
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 2032)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 02164175590
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Active, not recruiting
        • West China Hospital Sichuan University-respiratory ( Site 2018)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13958194313
      • Hangzhou, Zhejiang, China, 310052
        • Active, not recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
      • Hangzhou, Zhejiang, China, 310022
        • Active, not recruiting
        • Zhejiang Cancer Hospital-Breast Oncology ( Site 2008)
      • Hangzhou, Zhejiang, China, 310002
        • Completed
        • Hangzhou Cancer Hospital-Medical Oncology ( Site 2039)
      • Linhai, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027)
        • Contact:
          • Study Coordinator
          • Phone Number: 13867622009
      • Wenzhou, Zhejiang, China, 325000
        • Active, not recruiting
        • The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031)
  • Dominican Republic
    • Distrito Nacional
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10104
        • Recruiting
        • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: (829) 341-7774
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10102
        • Recruiting
        • Instituto de Oncologia ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: 8099650355
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Recruiting
        • CELAN,S.A ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +50242142081
      • Guatemala, Guatemala, 01010
        • Recruiting
        • Gastrosoluciones ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +50245711895
      • Guatemala, Guatemala, 01010
        • Recruiting
        • INTEGRA Cancer Institute ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +502 54530410
      • Guatemala, Guatemala, 01010
        • Recruiting
        • Oncomedica-Guatemala ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +50256973689
      • Guatemala, Guatemala, 01015
        • Recruiting
        • Grupo Medico Angeles ( Site 3007)
        • Contact:
          • Study Coordinator
          • Phone Number: +50257042323
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • Onco Go, S.A ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +50259042511
  • Hong Kong
      • Central, Hong Kong, 0000
        • Recruiting
        • Hong Kong Integrated Oncology Centre ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +85237006888
      • Hksar, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +85222554361
      • Jordan, Hong Kong
        • Recruiting
        • Hong Kong United Oncology Centre ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +85223868002
      • Lai Chi Kok, Hong Kong, 999007
        • Recruiting
        • Princess Margaret Hospital ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +85229902393
  • Hungary
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis University-Pulmonológiai Klinika ( Site 1209)
        • Contact:
          • Study Coordinator
          • Phone Number: +3614591500
    • Bacs-Kiskun
      • Kecskemét, Bacs-Kiskun, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +3676519853
    • Bekes
      • Gyula, Bekes, Hungary, 5700
        • Recruiting
        • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: +36665265262528
    • Gyor-Moson-Sopron
      • Gyor, Gyor-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: +3696507900
    • Heves
      • Kékestető, Heves, Hungary, 3233
        • Recruiting
        • Mátrai Gyógyintézet ( Site 1214)
        • Contact:
          • Study Coordinator
          • Phone Number: 203929250
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
        • Recruiting
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +3656503603
    • Pest
      • Budapest, Pest, Hungary, 1121
        • Recruiting
        • Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +3613913351
      • Torokbalint, Pest, Hungary, 2045
        • Recruiting
        • Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +36307005601
    • Zala
      • Zalaegerszeg, Zala, Hungary, 8900
        • Recruiting
        • Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +3692501527
  • India
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Recruiting
        • Artemis hospital ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: 8377828241
  • Japan
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital-Medical Oncology ( Site 1926)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-43-222-7171
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 1913)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-223-7151
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute ( Site 1915)
        • Contact:
          • Study Coordinator
          • Phone Number: +81669451181
      • Tokushima, Japan, 770-8503
        • Recruiting
        • Tokushima University Hospital ( Site 1917)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-88-631-3111
      • Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3813-3111
      • Tokyo, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Wakayama, Japan, 641-8510
        • Active, not recruiting
        • Wakayama Medical University Hospital ( Site 1910)
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Recruiting
        • National Hospital Organization Nagoya Medical Center ( Site 1920)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-951-1111
      • Toyoake, Aichi, Japan, 470-1192
        • Recruiting
        • Fujita Health University ( Site 1906)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-562-93-2111
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-964-5111
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 1912)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Gunma
      • Otashi, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center ( Site 1925)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-276-38-0771
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Recruiting
        • National Hospital Organization Hokkaido Cancer Center ( Site 1923)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-811-9111
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Active, not recruiting
        • Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922)
      • Takarazuka, Hyogo, Japan, 665-0827
        • Active, not recruiting
        • Takarazuka City Hospital ( Site 1924)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Center ( Site 1921)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-701-9581
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa cancer center ( Site 1916)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Miyagi
      • Sendai, Miyagi, Japan, 9800873
        • Recruiting
        • Sendai Kousei Hospital ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-222-6181
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-266-5111
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Active, not recruiting
        • Kansai Medical University Hospital ( Site 1914)
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital- Osakasayama Campus ( Site 1907)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-366-0221
      • Sakai, Osaka, Japan, 591-8555
        • Recruiting
        • National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-252-3021
      • Takatsuki, Osaka, Japan, 569-8686
        • Active, not recruiting
        • Osaka Medical and Pharmaceutical University Hospital ( Site 1908)
    • Shizuoka
      • Nagaizumi, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center ( Site 1905)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-55-989-5222
    • Tochigi
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Recruiting
        • Tochigi Cancer Center ( Site 1927)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-28-658-5151
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2072-2995
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-1599-1004
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3010-3214
      • Seoul, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital ( Site 1409)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220011130
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408)
        • Contact:
          • Study Coordinator
          • Phone Number: 8215881511
      • Seoul, Korea, Republic of, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2030-4360
    • Chungbuk
      • Cheongju-si, Chungbuk, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital-Internal medicine ( Site 1406)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-42-269-8760
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center-Lung Cancer Center ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: 82319201694
      • Seongnam, Kyonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-31-1588-3369
      • Suwon-si, Kyonggi-do, Korea, Republic of, 16247
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-31-1577-8588
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +60378414000
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Recruiting
        • Hospital Tengku Ampuan Afzan ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +6095572923
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10050
        • Recruiting
        • Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: 6042225685
      • George Town, Pulau Pinang, Malaysia, 10990
        • Recruiting
        • Hospital Pulau Pinang ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: 6042225768
    • Wilayah Persekutuan Putrajaya
      • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
        • Recruiting
        • National Cancer Institute ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: 60388925555
  • Mexico
      • Chihuahua, Mexico, 31217
        • Recruiting
        • Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +526141803800
      • Mexico city, Mexico, 14050
        • Active, not recruiting
        • Human Science Research Trials ( Site 0406)
      • Oaxaca, Mexico, 68000
        • Recruiting
        • Oaxaca Site Management Organization ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: +529515147056
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06700
        • Recruiting
        • Arké SMO S.A. de C.V. ( Site 0417)
        • Contact:
          • Study Coordinator
          • Phone Number: 33 38 08 08 56
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44680
        • Recruiting
        • Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411)
        • Contact:
          • Study Coordinator
          • Phone Number: +523316395372
    • Michoacan
      • Morelia, Michoacan, Mexico, 58260
        • Recruiting
        • Centro de Investigacion Clinica Chapultepec ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +524431478545
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Recruiting
        • iCan Oncology Center Centro Medico AVE ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +528125558169
    • Queretaro
      • Santiago de Queretaro, Queretaro, Mexico, 76000
        • Recruiting
        • Hospital H+ Queretaro ( Site 0416)
        • Contact:
          • Study Coordinator
          • Phone Number: 524421145730
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Recruiting
        • Medical Care and Research SA de CV ( Site 0409)
        • Contact:
          • Study Coordinator
          • Phone Number: +529999203879
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • Clínica Internacional - Sede San Borja ( Site 0506)
        • Contact:
          • Study Coordinator
          • Phone Number: +51992004083
      • Lima, Peru, 15038
        • Recruiting
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: +51993473019
      • Lima, Peru, 15076
        • Recruiting
        • Hospital Militar Central Luis Arias Schereiber ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: 51997468543
      • Lima, Peru, 15036
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 997881134
      • Lima, Peru, 15001
        • Active, not recruiting
        • Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508)
    • Qusqu
      • Cusco, Qusqu, Peru, CUSCO 84
        • Recruiting
        • UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: +51987531715
  • Philippines
    • National Capital Region
      • Quezon City, National Capital Region, Philippines, 1100
        • Recruiting
        • East Avenue Medical Center-Department of Medicine ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: 09178810580
      • Quezon City, National Capital Region, Philippines, 1100
        • Recruiting
        • Veterans Memorial Medical Center-Section of Oncology ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: 63917-173-8113
      • San Juan City, Metro Manila, National Capital Region, Philippines, 1502
        • Recruiting
        • CARDINAL SANTOS MEDICAL CENTER ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: 639176227242
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Recruiting
        • Cardiomed SRL Cluj-Napoca ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040724543672
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: 40727774974
    • Prahova
      • Ploiesti, Prahova, Romania, 100010
        • Recruiting
        • SC Medical Center Gral SRL ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040740062630
  • Russian Federation
      • Sankt-Peterburg, Russian Federation, 197758
        • Suspended
        • Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803)
    • Moskovskaya Oblast
      • Balashikha, Moskovskaya Oblast, Russian Federation, 143900
        • Suspended
        • Moscow Regional Oncological Dispensary ( Site 0812)
      • Moscow, Moskovskaya Oblast, Russian Federation, 121205
        • Suspended
        • Hadassah Medical-Oncology department ( Site 0814)
    • Moskva
      • Moscow, Moskva, Russian Federation, 121359
        • Suspended
        • Central Clinical Hospital of the Presidential Administrative Department ( Site 0802)
    • Nizhegorodskaya Oblast
      • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603081
        • Suspended
        • Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809)
    • Sankt-Peterburg
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 194291
        • Suspended
        • GBUZ LOKB-Oncology department #1 ( Site 0804)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Suspended
        • Republican Clinical Oncology Dispensary ( Site 0805)
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Wits Clinical Research ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: 27113390600
      • Johannesburg, Gauteng, South Africa, 2196
        • Recruiting
        • Medical Oncology Centre of Rosebank ( Site 0906)
        • Contact:
          • Study Coordinator
          • Phone Number: 0824445473
      • Pretoria, Gauteng, South Africa, 0181
        • Recruiting
        • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +27826061150
      • Sandton, Gauteng, South Africa, 2196
        • Recruiting
        • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: 27118830900
      • Soweto, Gauteng, South Africa, 2013
        • Recruiting
        • Wits Clinical Research-Wits Clinical Research Bara ( Site 0908)
        • Contact:
          • Study Coordinator
          • Phone Number: 0834077151
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4091
        • Recruiting
        • The Oncology Centre ( Site 0905)
        • Contact:
          • Study Coordinator
          • Phone Number: +27312088666
      • Richards Bay, Kwazulu-Natal, South Africa, 3900
        • Recruiting
        • Abraham Oncology ( Site 0907)
        • Contact:
          • Study Coordinator
          • Phone Number: 0845493493
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Recruiting
        • Cape Town Oncology Trials ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +27219443832
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital - Hsinchu branch ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: +886353261514529
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital-Chest ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-4-23592525 ext.3219
      • Tainan, Taiwan, 704
        • Recruiting
        • NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: +886623535354559
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital-Chest Medicine ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-25433535
      • Taipei, Taiwan, 110301
        • Recruiting
        • Taipei Medical University Hospital ( Site 1712)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-27372181
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 1709)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-28757865
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: +88622312345667511
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 1708)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-3-3281200 ext.2285
    • Changhua
      • Changhua County, Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital ( Site 1711)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-4-7238595
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +88677317123
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital-hematology&oncology ( Site 1710)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-87927208
  • Thailand
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
        • Recruiting
        • Chulalongkorn University ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: +662-256-4533
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
        • Recruiting
        • Ramathibodi Clinical Research Centre ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622011671
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624194489
  • Turkey
      • Ankara, Turkey, 06230
        • Active, not recruiting
        • Hacettepe Universitesi-oncology hospital ( Site 1001)
      • Ankara, Turkey, 06560
        • Active, not recruiting
        • Gazi Universitesi-Oncology ( Site 1003)
      • Ankara, Turkey, 06520
        • Active, not recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 1002)
      • Istanbul, Turkey, 34668
        • Active, not recruiting
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000)
      • Samsun, Turkey, 55200
        • Active, not recruiting
        • Samsun Medical Park Hastanesi-medical oncology ( Site 1005)
      • İstanbul, Turkey, 34457
        • Active, not recruiting
        • Acıbadem Maslak Hastanesi ( Site 1008)
    • Kayseri
      • Talas, Kayseri, Turkey, 38039
        • Active, not recruiting
        • Erciyes University Medical Oncology Department ( Site 1007)
  • Ukraine
    • Cherkaska Oblast
      • Cherkassy, Cherkaska Oblast, Ukraine, 18009
        • Suspended
        • Cherkasy Regional Oncology Dispensary ( Site 1110)
    • Chernihivska Oblast
      • Chernihiv, Chernihivska Oblast, Ukraine, 14029
        • Completed
        • Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
        • Suspended
        • Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100)
      • Kryvyi Rih, Dnipropetrovska Oblast, Ukraine, 50048
        • Suspended
        • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • Suspended
        • Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61103
        • Completed
        • Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • Suspended
        • National Cancer Institute ( Site 1114)
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21029
        • Suspended
        • Vinnytsia Regional Clinical Oncological Hospital ( Site 1102)
    • Zakarpatska Oblast
      • Uzhhorod, Zakarpatska Oblast, Ukraine, 88000
        • Suspended
        • Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120)
    • Zaporizka Oblast
      • Zaporizhzhia, Zaporizka Oblast, Ukraine, 69059
        • Suspended
        • Oncolife LLC-day-stay department ( Site 1107)
    • Zhytomyrska Oblast
      • Zhytomyr, Zhytomyrska Oblast, Ukraine, 10002
        • Suspended
        • Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103)
  • United States
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Active, not recruiting
        • Boca Raton Regional Hospital ( Site 0004)
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois Cancer Care ( Site 0026)
        • Contact:
          • Study Coordinator
          • Phone Number: 309-243-3000
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Research - David C. Pratt Cancer Center ( Site 0025)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-251-7057
      • Springfield, Missouri, United States, 65804
        • Completed
        • Mercy Research - Cancer and Hematology Center ( Site 0032)
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-351-5757
      • New York, New York, United States, 10065
        • Active, not recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 0013)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center-Hematology/Oncology ( Site 0030)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-728-2451

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 will receive pembrolizumab/vibostolimab as a coformulation (MK-7684A).
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 will receive pembrolizumab (MK-3475) alone.
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 Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
Time Frame: Up to ~59 months
OS is defined as the time from randomization to death due to any cause.
Up to ~59 months
OS in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~59 months
OS is defined as the time from randomization to death due to any cause.
Up to ~59 months
OS in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~59 months
OS is defined as the time from randomization to death due to any cause.
Up to ~59 months
Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~51 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 ~51 months
PFS in Participants With PD-L1 TPS ≥50%
Time Frame: Up to ~51 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 ~51 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~ 2 years
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 ~ 2 years
PFS in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~51 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 ~51 months
ORR in Participants With PD-L1 TPS ≥50%
Time Frame: Up to ~ 2 years
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 ~ 2 years
ORR in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~ 2 years
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 ~ 2 years
Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%
Time Frame: Up to ~59 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 ~59 months
DOR in Participants With PD-L1 TPS 1% to 49%
Time Frame: Up to ~59 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 ~59 months
DOR in Participants With PD-L1 TPS ≥1%
Time Frame: Up to ~59 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 ~59 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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~107 weeks
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 ~107 weeks
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
Time Frame: Baseline and up to ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Time Frame: Baseline and up to ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
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 ~107 weeks
Number of Participants Who Experienced One or More Adverse Events (AEs)
Time Frame: Up to ~115 weeks
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 ~115 weeks
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Time Frame: Up to ~103 weeks
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 ~103 weeks

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 (Estimated)

April 21, 2026

Study Completion (Estimated)

June 5, 2028

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 (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-003
  • MK-7684A-003 (Other Identifier: Merck)
  • jRCT2021210025 (Registry Identifier: jRCT)
  • KEYVIBE-003 (Other Identifier: Merck)
  • 2020-004049-35 (EudraCT Number)
  • PHRR230831-006054 (Registry Identifier: PHRR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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

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