Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)

April 4, 2024 updated by: Merck Sharp & Dohme LLC

Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following:

  • progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants.
  • overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

784

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

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Recruiting
        • Canberra Hospital ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 610251242220
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Icon Cancer Centre Hobart ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: 0437636224
    • Victoria
      • Ballarat Central, Victoria, Australia, 3350
        • Recruiting
        • Ballarat Health Services-Medical Oncology ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 0413578465
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Hospital-Oncology and Haematology ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: (03) 9784 7071
      • Melbourne, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: 61392313167
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Recruiting
        • Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: +55212399-0212
      • Sao Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center-CAPEC ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +551121895021
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: +5551993590437
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Recruiting
        • James Lind Centro de Investigación del Cáncer ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: +56452982404
    • Biobio
      • Concepción, Biobio, Chile, 4070196
        • Recruiting
        • Biocenter ( Site 0208)
        • Contact:
          • Study Coordinator
          • Phone Number: +56974779078
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión ( Site 0209)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: +56998744662
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: +56981369487
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: +56322323980
  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: 13911235467
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-88196948
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-88196479
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321)
        • Contact:
          • Study Coordinator
          • Phone Number: 18580408265
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital ( Site 0316)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 0591-62752500
      • Fuzhou Fujian, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 0591 86218325
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University-oncology ( Site 0317)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 0592-2132222
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-62787730
    • Hebei
      • Shijiazhuang, Hebei, China, 050035
        • Recruiting
        • Fourth Hospital of Hebei Medical University ( Site 0331)
        • Contact:
          • Study Coordinator
          • Phone Number: 13931182128
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital ( Site 0333)
        • Contact:
          • Study Coordinator
          • Phone Number: 13607695140
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0315)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 027-85726300
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital ( Site 0311)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 027-87670318
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University-Oncology department ( Site 0310)
        • Contact:
          • Study Coordinator
          • Phone Number: 13875898127
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89762231
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University ( Site 0314)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13951106391
      • Zhenjiang, Jiangsu, China, 212000
        • Recruiting
        • Affiliated Hospital of Jiangsu University ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613952850016
    • Jilin
      • Changchun, Jilin, China, 132000
        • Recruiting
        • Jilin Cancer Hospital-oncology department ( Site 0319)
        • Contact:
          • Study Coordinator
          • Phone Number: 0431-80596065
    • Shandong
      • Jinan, Shandong, China, 250001
        • Recruiting
        • Shandong Provincial Hospital ( Site 0326)
        • Contact:
          • Study Coordinator
          • Phone Number: 15168888787
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Qingdao Central Hospital-Endocrinology ( Site 0332)
        • Contact:
          • Study Coordinator
          • Phone Number: +86-18660229210
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: 13651635103
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-64175590
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13817025327
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Cancer Hospital-Pulmonology ( Site 0322)
        • Contact:
          • Study Coordinator
          • Phone Number: 18635169066
    • Sichuan
      • Cheng Du, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University ( Site 0324)
        • Contact:
          • Study Coordinator
          • Phone Number: 18980601766
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital-radiotherapy ( Site 0329)
        • Contact:
          • Study Coordinator
          • Phone Number: 022-23524155
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310002
        • Recruiting
        • Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: 18857110928
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 13868071869
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital ( Site 0308)
        • Contact:
          • Study Coordinator
          • Phone Number: 13858037993
  • Costa Rica
    • San Jose
      • San José, San Jose, Costa Rica, 10103
        • Recruiting
        • CIMCA ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +50683893636
      • San José, San Jose, Costa Rica, 11303
        • Recruiting
        • PROCLINICAL Pharma ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: 50683778387
      • Santa Ana, San Jose, Costa Rica, 10903
        • Recruiting
        • Hospital Metropolitano - Sede Lindora ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +5064035 1212
  • Dominican Republic
    • Distrito Nacional
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10102
        • Recruiting
        • Instituto de Oncologia ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +18099615245
    • Santo Domingo
      • Distrito Nacional, Santo Domingo, Dominican Republic, 10148
        • Recruiting
        • Onconet ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +18098611000
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0603
        • Contact:
          • Study Coordinator
          • Phone Number: +4930450665005
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: +4937133343072
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • Recruiting
        • LungenClinic Grosshansdorf-Onkologie ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +4941026012101
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo
        • Contact:
          • Study Coordinator
          • Phone Number: +4943150022563
  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • European Interbalkan Medical Center ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: 00302310400368
    • Attiki
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107700220
      • Athens, Attiki, Greece, 115 26
        • Recruiting
        • Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: 00302106972246
      • Athens, Attiki, Greece, 185 47
        • Recruiting
        • Metropolitan Hospital ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: 00302104809339
      • Athens, Attiki, Greece, 115 28
        • Recruiting
        • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: 00306946462998
      • Nea Kifissia, Attiki, Greece, 136 77
        • Recruiting
        • General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 07
        • Contact:
          • Study Coordinator
          • Phone Number: 00302103501711
    • Irakleio
      • Heraklion, Irakleio, Greece, 715 00
        • Recruiting
        • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: 00302810392783
  • Guatemala
      • Ciudad de Guatemala, Guatemala, 01010
        • Recruiting
        • Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +502 30635474
      • Quetzaltenango, Guatemala, 09001
        • Recruiting
        • Centro Regional de Sub Especialidades Médicas SA ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +502 59450559
      • Quetzaltenango, Guatemala, 09002
        • Recruiting
        • Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)
        • Contact:
          • Study Coordinator
          • Phone Number: +502 59458053
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-4-7776412
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +972587040620
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: + 9729378101
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-ONCOLOGY ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: 97235307096
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +972 36973494
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +390303995271
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia medica Toraco-Polmonare ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: 390817770291
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Recruiting
        • Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: 3906225418020
    • Lombardia
      • Milan, Lombardia, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 390223905000
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: 390226436627
      • Monza, Lombardia, Italy, 20900
        • Recruiting
        • Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 390392339678
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +390382503132
  • Japan
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute ( Site 1209)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center ( Site 1211)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-999-1111
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 1212)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0046
        • Recruiting
        • Kobe Minimally Invasive Cancer Center ( Site 1210)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-78-304-4100
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa cancer center ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Miyagi
      • Natori, Miyagi, Japan, 981-1293
        • Recruiting
        • Miyagi Cancer Center ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-384-3151
      • Sendai, Miyagi, Japan, 9800873
        • Recruiting
        • Sendai Kousei Hospital ( Site 1213)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-222-6181
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-266-5111
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-683-1221
    • Saitama
      • Ina-machi, Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Prefectural Cancer Center ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-48-722-1111
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Shinagawa, Tokyo, Japan, 142-8666
        • Recruiting
        • Showa University Hospital ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3784-8000
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: 820222280880
    • Chungbuk
      • Cheongju-si, Chungbuk, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital-Internal medicine ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: 82432696898
    • Kyonggi-do
      • Suwon-si, Kyonggi-do, Korea, Republic of, 16247
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: 82312498485
      • Suwon-si, Kyonggi-do, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital-Hematology-Oncology ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: 820312194266
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +6017233-6295
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre-Clinical Oncology ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +6013-5121839
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Recruiting
        • Hospital Pulau Pinang ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +604-2225767
  • Mexico
      • Chihuahua, Mexico, 31217
        • Recruiting
        • Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 (614) 180-3800
      • Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: 9516035559
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06700
        • Recruiting
        • Arké SMO S.A. de C.V. ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 55115833
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44680
        • Recruiting
        • Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 (33) 1639-5372
  • Portugal
      • Porto, Portugal, 4099-001
        • Recruiting
        • Centro Hospitalar do Porto - Hospital de Santo António ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +351222077500
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225084000
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1998-018
        • Recruiting
        • Hospital CUF Descobertas ( Site 2006)
        • Contact:
          • Study Coordinator
          • Phone Number: +351210025200
  • Romania
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 010626
        • Recruiting
        • Centrul Medical Medicover Victoria ( Site 2106)
        • Contact:
          • Study Coordinator
          • Phone Number: +40737877881
    • Cluj
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • Amethyst Radiotherapy Center ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: 40742206212
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: 40727774974
    • Ilfov
      • Otopeni, Ilfov, Romania, 075100
        • Recruiting
        • Radiology Therapeutic Center ( Site 2108)
        • Contact:
          • Study Coordinator
          • Phone Number: 40723171603
    • Timis
      • Timișoara, Timis, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040745100495
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6055
        • Recruiting
        • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: 27413630581
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0040
        • Recruiting
        • Wilgers Oncology Centre ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +27128072744
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4091
        • Recruiting
        • The Oncology Centre ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: +27312088666
      • Richards Bay, Kwazulu-Natal, South Africa, 3900
        • Recruiting
        • Abraham Oncology ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: 0357800247
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Recruiting
        • Cape Town Oncology Trials ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: 27219443832
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746085
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275402
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: 981950511
    • Madrid, Comunidad De
      • Pozuelo de Alarcon, Madrid, Comunidad De, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034914521987
  • Turkey
      • Adana, Turkey, 01250
        • Recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607)
        • Contact:
          • Study Coordinator
          • Phone Number: 03223444444
      • Ankara, Turkey, 06010
        • Recruiting
        • Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: (0312) 042000
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universitesi-oncology hospital ( Site 2605)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123053432
      • Ankara, Turkey, 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)
        • Contact:
          • Study Coordinator
          • Phone Number: +903122536666
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara City Hospital-Medical Oncology ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +903125526000
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)
        • Contact:
          • Study Coordinator
          • Phone Number: 00902162803333
    • Istanbul
      • Stanbul, Istanbul, Turkey, 34214
        • Recruiting
        • Medipol Mega Universite Hastanesi-oncology ( Site 2611)
        • Contact:
          • Study Coordinator
          • Phone Number: +905325280486
    • Izmir
      • Bornova, Izmir, Turkey, 35100
        • Recruiting
        • Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +902323434343
      • Izmir, Karsiyaka, Izmir, Turkey, 009035575
        • Recruiting
        • I.E.U. Medical Point Hastanesi-Oncology ( Site 2612)
        • Contact:
          • Study Coordinator
          • Phone Number: +905052642353
  • United States
    • California
      • Long Beach, California, United States, 90822
        • Recruiting
        • VA Long Beach Healthcare System ( Site 2831)
        • Contact:
          • Study Coordinator
          • Phone Number: 562-826-8000
      • Los Angeles, California, United States, 90073
        • Recruiting
        • VA West Los Angeles Medical Center ( Site 2808)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-478-3711
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Millennium Oncology Research Clinic ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-450-1808
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center ( Site 2800)
        • Contact:
          • Study Coordinator
          • Phone Number: 386-774-1223
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center ( Site 2828)
        • Contact:
          • Study Coordinator
          • Phone Number: 855-702-8222
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan St. Francis Health ( Site 2812)
        • Contact:
          • Study Coordinator
          • Phone Number: 317-528-7060
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MFSMC-HJWCI ( Site 2804)
        • Contact:
          • Study Coordinator
          • Phone Number: 443-777-7147
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center ( Site 2829)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-638-8265
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Chan Medical School ( Site 2815)
        • Contact:
          • Study Coordinator
          • Phone Number: 508-334-1000
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)
        • Contact:
          • Study Coordinator
          • Phone Number: 417-269-6115
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 2805)
        • Contact:
          • Study Coordinator
          • Phone Number: 732-235-2465
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 2821)
        • Contact:
          • Study Coordinator
          • Phone Number: 443-570-5327
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital ( Site 2835)
        • Contact:
          • Study Coordinator
          • Phone Number: 914-849-7630
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-335-2400
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Recruiting
        • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827)
        • Contact:
          • Study Coordinator
          • Phone Number: 717-544-9400
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Clinical Research Institute ( Site 2813)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-955-8874
    • Texas
      • Houston, Texas, United States, 77090
        • Recruiting
        • Millennium Research & Clinical Development ( Site 2811)
        • Contact:
          • Study Coordinator
          • Phone Number: 281-440-5006
      • Temple, Texas, United States, 76504
        • Completed
        • Central Texas Veterans health care-Oncology & Hematology ( Site 2819)
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Health System ( Site 2817)
        • Contact:
          • Study Coordinator
          • Phone Number: 253-403-6177

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Inclusion Criteria

  • Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
  • Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
  • Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
  • Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
  • Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
  • Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
  • Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
  • Has a life expectancy of at least 6 months

Exclusion Criteria

  • Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
  • Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
  • Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
  • Is expected to require any other form of antineoplastic therapy, while on study
  • Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
  • 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 medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
  • Has had an allogenic tissue/solid organ transplant

Pemetrexed-specific Criteria:

  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
  • Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Biological: pembrolizumab/vibostolimab
Administered as an intravenous (IV) infusion
Other Names:
  • MK-7684A
Drug: cisplatin
Administered as an IV infusion
Other Names:
  • PLATINOL-AQ®
Drug: pemetrexed
Administered as an IV infusion
Other Names:
  • ALIMTA®
Drug: etoposide
Administered as an IV infusion
Other Names:
  • TOPOSAR®
Drug: carboplatin
Administered as an IV infusion
Other Names:
  • PARAPLATIN®
Drug: paclitaxel
Administered as an IV infusion
Other Names:
  • TAXOL®
Radiation: thoracic radiotherapy
Administered as an external beam radiation
Active Comparator: chemotherapy+radiotherapy+durvalumab

For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.

Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Drug: cisplatin
Administered as an IV infusion
Other Names:
  • PLATINOL-AQ®
Drug: pemetrexed
Administered as an IV infusion
Other Names:
  • ALIMTA®
Drug: etoposide
Administered as an IV infusion
Other Names:
  • TOPOSAR®
Drug: carboplatin
Administered as an IV infusion
Other Names:
  • PARAPLATIN®
Drug: paclitaxel
Administered as an IV infusion
Other Names:
  • TAXOL®
Radiation: thoracic radiotherapy
Administered as an external beam radiation
Biological: durvalumab
Administered as an IV infusion
Other Names:
  • IMFINZI®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) For All Participants
Time Frame: Up to approximately 55 months
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Up to approximately 55 months
Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Time Frame: Up to approximately 55 months
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Up to approximately 55 months
Overall Survival (OS) For All Participants
Time Frame: Up to approximately 75 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 75 months
Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Time Frame: Up to approximately 75 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 75 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) For All Participants
Time Frame: Up to approximately 75 months
ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Up to approximately 75 months
Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Time Frame: Up to approximately 75 months
ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Up to approximately 75 months
Number of Participants Who Experience at Least One Adverse Event (AE)
Time Frame: Up to approximately 75 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 75 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to approximately 75 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 75 months
Duration of Response (DOR) For All Participants
Time Frame: Up to approximately 75 months
Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Up to approximately 75 months
Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Time Frame: Up to approximately 75 months
Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Up to approximately 75 months
Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants
Time Frame: Up to approximately 75 months post randomization
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time Frame: Up to approximately 75 months post randomization
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Time Frame: Up to approximately 75 months post randomization
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time Frame: Up to approximately 75 months post randomization
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants
Time Frame: Up to approximately 75 months post randomization
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Time Frame: Up to approximately 75 months post randomization
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Time Frame: Up to approximately 75 months post randomization
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Time Frame: Up to approximately 75 months post randomization
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Time Frame: Up to approximately 75 months post randomization
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time Frame: Up to approximately 75 months post randomization
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Up to approximately 75 months post randomization

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)

May 3, 2022

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 4, 2029

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7684A-006
  • MK-7684A-006 (Other Identifier: Merck)
  • KEYVIBE-006 (Other Identifier: Merck)
  • jRCT2021220015 (Registry Identifier: jRCT)
  • 2021-005135-23 (EudraCT Number)
  • PHRR230831-006071 (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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