Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

September 1, 2026 updated by: Merck Sharp & Dohme LLC

Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All participants undergo an initial induction phase of four cycles, each cycle consisting of pembrolizumab every 3 weeks (q3w) + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance.

Study Type

Interventional

Enrollment (Estimated)

851

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

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman-Oncology ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 11 4827-7000
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: 3221 8900 int 8123
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 0223 496-3224
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5800AEV
        • Recruiting
        • Instituto Médico Río Cuarto ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: +543584679361
    • Río Negro Province
      • Bariloche, Río Negro Province, Argentina, R8402APU
        • Recruiting
        • Fundacion Intecnus ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: 0294 474-6050
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 0341 420-0222
  • Austria
      • Vienna, Austria, 1130
        • Recruiting
        • Klinik Hietzing ( Site 0740)
        • Contact:
          • Study Coordinator
          • Phone Number: +43 1 80110 2471
      • Vienna, Austria, 1140
        • Recruiting
        • Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730)
        • Contact:
          • Study Coordinator
          • Phone Number: 004319106042002
      • Vienna, Austria, 1210
        • Recruiting
        • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710)
        • Contact:
          • Study Coordinator
          • Phone Number: 00431277005634
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720)
        • Contact:
          • Study Coordinator
          • Phone Number: +4373276760
  • Brazil
      • São Paulo, Brazil, 01321-001
        • Recruiting
        • Hospital Paulistano ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: +551131411083
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Recruiting
        • Hospital do Cancer de Pernambuco ( Site 0312)
        • Contact:
          • Study Coordinator
          • Phone Number: : +55 81 99631 6566
    • Piauí
      • Teresina, Piauí, Brazil, 64049-200
        • Recruiting
        • Vencer Centro de Pesquisa Clínica ( Site 0309)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 86 99900-7799
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311)
        • Contact:
          • Study Coordinator
          • Phone Number: +555132148143
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: 555133572092
      • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96830-180
        • Recruiting
        • Instituto de Oncologia Saint Gallen ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: 5551991898942
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Hospital de Base de São José do Rio Preto ( Site 0310)
        • Contact:
          • Study Coordinator
          • Phone Number: (17) 3201-5054
  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: 613-549-6666
      • Kitchener, Ontario, Canada, N2G 1G3
        • Recruiting
        • Waterloo Regional Health Network (WRHN) ( Site 0153)
        • Contact:
          • Study Coordinator
          • Phone Number: 519749430
    • Quebec
      • Montreal, Quebec, Canada, H3T 1M5
        • Recruiting
        • St. Marys Hospital Center ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-345-3511
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 514 934-1934
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Recruiting
        • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 819-697-3333
  • Chile
      • Antofagasta, Chile, 1240000
        • Recruiting
        • Bradford Hill Norte ( Site 0420)
        • Contact:
          • Study Coordinator
          • Phone Number: 56442023631
    • Maule Region
      • Talca, Maule Region, Chile, 3481349
        • Completed
        • Centro de Investigación del Maule ( Site 0419)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 0409)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224457254
      • Santiago, Region M. de Santiago, Chile, 8330024
        • Recruiting
        • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +56223543334
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: 56229490970
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: 56323320850
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Active, not recruiting
        • Peking Union Medical College Hospital ( Site 2412)
      • Beijing, Beijing Municipality, China, 100142
        • Active, not recruiting
        • Beijing Cancer Hospital ( Site 2411)
      • Beijing, Beijing Municipality, China, 100142
        • Active, not recruiting
        • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400042
        • Active, not recruiting
        • Army Medical Center of People's Liberation Army-respiratory ( Site 2426)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Active, not recruiting
        • Fujian Provincial Cancer Hospital ( Site 2419)
      • Xiamen, Fujian, China, 361003
        • Active, not recruiting
        • The First Affiliated hospital of Xiamen University-oncology ( Site 2420)
    • Guangdong
      • Guangzhou, Guangdong, China, 510160
        • Active, not recruiting
        • The First Affiliated Hospital of Guangzhou Medical University ( Site 2417)
      • Guangzhou, Guangdong, China, 510515
        • Active, not recruiting
        • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2416)
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Active, not recruiting
        • Harbin Medical University Cancer Hospital-oncology of department ( Site 2415)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Active, not recruiting
        • Henan Cancer Hospital-Pneumology department ( Site 2423)
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Active, not recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 2424)
    • Hunan
      • Changsha, Hunan, China, 410011
        • Active, not recruiting
        • The Second Xiangya Hospital of Central South University-Oncology ( Site 2418)
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Active, not recruiting
        • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 2402)
      • Yangzhou, Jiangsu, China, 225001
        • Active, not recruiting
        • Northern Jiangsu People's Hospital-General Surgery Department ( Site 2403)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Active, not recruiting
        • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 2404)
      • Nanchang, Jiangxi, China, 330006
        • Active, not recruiting
        • The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2405)
    • Jilin
      • Changchun, Jilin, China, 130000
        • Active, not recruiting
        • Jilin Province Tumor Hospital-GCP office ( Site 2413)
      • Changchun, Jilin, China, 130021
        • Active, not recruiting
        • The First Hospital of Jilin University-Oncology ( Site 2414)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200120
        • Active, not recruiting
        • Shanghai East Hospital ( Site 2428)
      • Shanghai, Shanghai Municipality, China, 200433
        • Active, not recruiting
        • Shanghai Pulmonary Hospital ( Site 2427)
    • Sichuan
      • Chengdu, Sichuan, China, 610042
        • Active, not recruiting
        • Sichuan Cancer hospital. ( Site 2421)
      • Chengdu, Sichuan, China, 610041
        • Active, not recruiting
        • West China Hospital, Sichuan University ( Site 2422)
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Active, not recruiting
        • The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 2425)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Active, not recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine-Respiratory Department ( Site 2406)
      • Hangzhou, Zhejiang, China, 310016
        • Active, not recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 2407)
      • Hangzhou, Zhejiang, China, 310022
        • Active, not recruiting
        • Zhejiang Cancer Hospital-Breast Oncology ( Site 2408)
      • Taizhou, Zhejiang, China, 317000
        • Active, not recruiting
        • Taizhou Hospital of Zhejiang Province ( Site 2430)
      • Wenzhou, Zhejiang, China, 325015
        • Active, not recruiting
        • The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2409)
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Recruiting
        • Centro Cancerológico del Caribe (CECAC) ( Site 0509)
        • Contact:
          • Study Coordinator
          • Phone Number: +573132121774
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: +573219198898
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Active, not recruiting
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Recruiting
        • Oncologos del Occidente ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3187715522
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili-Oncology CIC ( Site 0505)
        • Contact:
          • Study Coordinator
          • Phone Number: + 57 3126160090
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +420588443666
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +420532233843
    • Ostrava Mesto
      • Ostrava-Vitkovice, Ostrava Mesto, Czechia, 703 00
        • Recruiting
        • Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: +420595633400
    • Pardubice Region
      • Pardubice, Pardubice Region, Czechia, 532 03
        • Recruiting
        • Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: +420466016436
  • France
      • Paris, France, 75475
        • Completed
        • Hôpital Saint-Louis ( Site 0906)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13009
        • Recruiting
        • Clinique Clairval ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: +33496196230
    • Lorraine
      • Vantoux, Lorraine, France, 57070
        • Recruiting
        • Hôpital Robert Schuman ( Site 0907)
        • Contact:
          • Study Coordinator
          • Phone Number: +33387536012
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49055
        • Recruiting
        • Institut de Cancérologie de l'Ouest ( Site 0908)
        • Contact:
          • Study Coordinator
          • Phone Number: 0244853754
    • Vaucluse
      • Avignon, Vaucluse, France, 84000
        • Recruiting
        • Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +33490276397
    • Vendee
      • La Roche-sur-Yon, Vendee, France, 85000
        • Recruiting
        • CHD Vendee ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +33251446572
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930450665005
    • North Rhine-Westphalia
      • Dortmund, North Rhine-Westphalia, Germany, 44309
        • Recruiting
        • GEFOS Gesellschaft f. onkologische Studien ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +492312061692
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +4920117424003
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 451 500 45002
    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • Recruiting
        • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +493658287758
  • Hungary
      • Budapest, Hungary, 1121
        • Recruiting
        • Országos Korányi Pulmonológiai Intézet ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +3613913228
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: +3676516700
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Petz Aladar Egyetemi Oktato Korhaz ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +3696507900
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
        • Recruiting
        • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +3656503603
    • Pest County
      • Törökbálint, Pest County, Hungary, 2045
        • Recruiting
        • Reformatus Pulmonologiai Centrum ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +36307005601
    • Zala County
      • Zalaegerszeg, Zala County, Hungary, 8900
        • Recruiting
        • Zala Megyei Szent Rafael Kórház ( Site 1110)
        • Contact:
          • Study Coordinator
          • Phone Number: +36 92 501527
  • Ireland
      • Dublin, Ireland, D08 A978
        • Recruiting
        • St. James's Hospital ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +35314103606
  • Israel
      • Haifa, Israel, 3109601
        • Completed
        • Rambam Health Care Campus-Oncology Division ( Site 1302)
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-2-6555768
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-3-9378086
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-3-5307032
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414)
        • Contact:
          • Study Coordinator
          • Phone Number: 0303996536
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale San Martino ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: +390105558905
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliera Maggiore della Carita ( Site 1416)
        • Contact:
          • Study Coordinator
          • Phone Number: +3903213733989
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 1410)
        • Contact:
          • Study Coordinator
          • Phone Number: 0382503938
      • Varese, Italy, 21100
        • Completed
        • Ospedale di Circolo e Fondazione Macchi Varese-Oncology ( Site 1413)
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi ( Site 1415)
        • Contact:
          • Study Coordinator
          • Phone Number: +390458128120
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +390817770291
    • Lazio
      • Rome, Lazio, Italy, 00184
        • Recruiting
        • Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409)
        • Contact:
          • Study Coordinator
          • Phone Number: +390677054001
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: 390223902190
      • Monza, Lombardy, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 1412)
        • Contact:
          • Study Coordinator
          • Phone Number: 0392334514
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1408)
        • Contact:
          • Study Coordinator
          • Phone Number: +390282244069
    • Roma
      • Rome, Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +390652665075
  • Japan
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital ( Site 2517)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-43-222-7171
      • Fukuoka, Japan, 810-8563
        • Recruiting
        • National Hospital Organization Kyushu Medical Center ( Site 2509)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-852-0700
      • Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital ( Site 2505)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-266-5111
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2506)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-762-6111
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital ( Site 2519)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-744-1958
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital ( Site 2515)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-562-93-2111
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Recruiting
        • Hirosaki University Hospital ( Site 2514)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-172-33-5111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-47-133-1111
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital ( Site 2511)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-964-5111
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center ( Site 2510)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-27-638-0771
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0046
        • Recruiting
        • Kobe Minimally Invasive Cancer Center ( Site 2528)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-78-304-4100
      • Takarazuka, Hyōgo, Japan, 665-0827
        • Recruiting
        • Takarazuka City Hospital ( Site 2508)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-797-87-1161
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital ( Site 2513)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-76-265-2000
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 2521)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Yokohama, Kanagawa, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Center ( Site 2518)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-701-9581
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Recruiting
        • Kochi Medical School Hospital ( Site 2526)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-88-866-5811
    • Mie-ken
      • Matsusaka, Mie-ken, Japan, 515-8544
        • Recruiting
        • Saiseikai Matsusaka Municipal Hospital ( Site 2522)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-598-23-1515
    • Miyagi
      • Sendai, Miyagi, Japan, 981-0914
        • Recruiting
        • Sendai Kousei Hospital ( Site 2507)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-728-8000
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 2525)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-717-7000
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
    • Saga-ken
      • Ureshino, Saga-ken, Japan, 843-0393
        • Recruiting
        • National Hospital Organization Ureshino Medical Center ( Site 2524)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-954-43-1120
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Prefectural Cancer Center ( Site 2512)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-48-722-1111
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital ( Site 2527)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-282-86-1111
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 2500)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Shinjuku, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine ( Site 2516)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3202-7181
      • Ōta-ku, Tokyo, Japan, 143-8541
        • Recruiting
        • Toho University Omori Medical Center ( Site 2520)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3762-4151
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-0241
        • Recruiting
        • National Hospital Organization Yamaguchi Ube Medical Center ( Site 2523)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-836-58-2300
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • Oncosalud-Clinical Research ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +51957511783
      • Lima, Peru, 15076
        • Recruiting
        • Hospital Militar Central Coronel Luis Arias Schereiber ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +51997468543
    • La Libertad
      • Trujillo, La Libertad, Peru, 13008
        • Recruiting
        • Clínica San Antonio ( Site 0606)
        • Contact:
          • Study Coordinator
          • Phone Number: +51943529090
    • Lambayeque
      • Chiclayo, Lambayeque, Peru, 14001
        • Active, not recruiting
        • Clínicas AUNA Sede Chiclayo ( Site 0604)
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: 52 374 35 89
      • Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland, 86-300
        • Completed
        • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1513)
    • Lesser Poland Voivodeship
      • Gorlice, Lesser Poland Voivodeship, Poland, 38-300
        • Completed
        • Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1507)
      • Krakow, Lesser Poland Voivodeship, Poland, 31-826
        • Recruiting
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1515)
        • Contact:
          • Study Coordinator
          • Phone Number: +48126468634
    • Lower Silesian Voivodeship
      • Poznań, Lower Silesian Voivodeship, Poland, 60-569
        • Recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 1510)
        • Contact:
          • Study Coordinator
          • Phone Number: +48616654203
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie ( Site 1518)
        • Contact:
          • Study Coordinator
          • Phone Number: +48814485180
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225463066
      • Warsaw, Masovian Voivodeship, Poland, 01-138
        • Recruiting
        • Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 1523)
        • Contact:
          • Study Coordinator
          • Phone Number: +48224312100
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: 48 16 677 55 10
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 1520)
        • Contact:
          • Study Coordinator
          • Phone Number: +48856646888
    • West Pomeranian Voivodeship
      • Poland, West Pomeranian Voivodeship, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki w Koszalinie. ( Site 1517)
        • Contact:
          • Study Coordinator
          • Phone Number: 94 34 88 930
  • Romania
      • Brasov, Romania, 500052
        • Recruiting
        • SC ONCO CARD SRL ( Site 2007)
        • Contact:
          • Study Coordinator
          • Phone Number: +40268960
      • Bucharest, Romania, 012292
        • Recruiting
        • Lotus-Med ( Site 2009)
        • Contact:
          • Study Coordinator
          • Phone Number: +4021.9989
      • Sibiu, Romania, 550253
        • Recruiting
        • Clinica Polisano ( Site 2008)
        • Contact:
          • Study Coordinator
          • Phone Number: +40219383
    • Bucharest
      • Bucharest, Bucharest, Romania, 010626
        • Recruiting
        • Centrul Medical Medicover Victoria ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +40219896
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Recruiting
        • Cardiomed SRL Cluj-Napoca ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +40264406600
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +40219368
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +40731604432
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: +40356460995
  • South Korea
      • Seoul, South Korea, 02447
        • Recruiting
        • Kyung Hee University Hospital ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-958-8511
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3010-5902
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital-Internal Medicine ( Site 2103)
        • Contact:
          • Study Coordinator
          • Phone Number: +82226261114
    • Incheon
      • Bupyeong-gu, Incheon, South Korea, 21431
        • Recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 2106)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-32-280-5172
    • Kyongsangnam-do
      • Yangsan, Kyongsangnam-do, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital ( Site 2104)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-55-360-4764
    • Pusan-Kwangyokshi
      • Busan, Pusan-Kwangyokshi, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-51-240-7889
    • Taegu-Kwangyokshi
      • Deagu, Taegu-Kwangyokshi, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: +532003091
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, South Korea, 35015
        • Recruiting
        • Chungnam national university hospital-Department of Internal Medicine ( Site 2107)
        • Contact:
          • Study Coordinator
          • Phone Number: +82422807140
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: 915504800 ext253900
      • Seville, Spain, 41014
        • Recruiting
        • Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: 955015273
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +34981950511
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Recruiting
        • Hospital Insular de Gran Canaria-Oncology ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 928441738
    • Malaga
      • Málaga, Malaga, Spain, 29004
        • Recruiting
        • Hospital Quirón Málaga ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 95 194 00 00
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung ( Site 2207)
        • Contact:
          • Study Coordinator
          • Phone Number: +88677317123
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: +886423592525x3219
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 2205)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital-Chest Medicine ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +88625433535
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 2208)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456x267511
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633281200
    • Taipei
      • Taipei City, Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Cancer Center (NTUCC) ( Site 2209)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456x267511
    • Taoyuan
      • Taoyuan City, Taoyuan, Taiwan, 33004
        • Recruiting
        • Taoyuan General Hospital ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633698721
  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624194489
      • Dusit, Bangkok, Thailand, 10300
        • Recruiting
        • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622443000
    • Changwat Chanthaburi
      • Mueang, Changwat Chanthaburi, Thailand, 22000
        • Recruiting
        • Prapokklao Hospital ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: +6639319666
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: +6643366568
    • Changwat Lampang
      • Lampang, Changwat Lampang, Thailand, 52000
        • Recruiting
        • Lampang Cancer Hospital ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: +6654335262
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind hospital ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: +6674451469
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +6653935480
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 (312) 305 50 00
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi Universitesi-Oncology ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 202 20 00
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: +90312 552 60 00
      • Izmir, Turkey (Türkiye), 35360
        • Recruiting
        • Izmir Atatürk Training and Research Hospital ( Site 1810)
        • Contact:
          • Study Coordinator
          • Phone Number: +905324078648
      • Kayseri, Turkey (Türkiye), 38010
        • Recruiting
        • Memorial Kayseri Hastanesi ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +90352315 66 66-6615
      • Mersin, Turkey (Türkiye), 33240
        • Recruiting
        • Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1808)
        • Contact:
          • Study Coordinator
          • Phone Number: (0324) 225 10 00
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Samsun Medical Park Hastanesi-medical oncology ( Site 1806)
        • Contact:
          • Study Coordinator
          • Phone Number: +905334296797
    • Istanbul
      • Stanbul, Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Medipol Mega Universite Hastanesi-oncology ( Site 1811)
        • Contact:
          • Study Coordinator
          • Phone Number: +905325280486
  • United Arab Emirates
    • Abu Dhabi Emirate
      • Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 112412
        • Completed
        • Cleveland Clinic Abu Dhabi ( Site 2650)
      • Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 92510
        • Completed
        • Burjeel Medical City ( Site 2600)
  • United Kingdom
    • Derry and Strabane
      • Londonderry, Derry and Strabane, United Kingdom, BT47 6SB
        • Recruiting
        • North West Cancer Centre ( Site 1908)
        • Contact:
          • Study Coordinator
          • Phone Number: 02871345171
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital ( Site 1906)
        • Contact:
          • Study Coordinator
          • Phone Number: 01803 656629
    • London, City of
      • London, London, City of, United Kingdom, EC1A7BE
        • Recruiting
        • St Bartholomew's Hospital ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Recruiting
        • City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 501-906-3000
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122)
        • Contact:
          • Study Coordinator
          • Phone Number: 818-748-4723
      • San Diego, California, United States, 92123
        • Recruiting
        • Sharp Memorial Hospital ( Site 9544)
        • Contact:
          • Study Coordinator
          • Phone Number: 858-939-7201
    • Colorado
      • Golden, Colorado, United States, 80401
        • Recruiting
        • Intermountain Health Cancer Center Lutheran Hospital ( Site 0119)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-403-6381
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • Intermountain Health St. Mary's Regional Hospital ( Site 0116)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-298-6576
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Washington Hospital Center ( Site 0037)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-877-8839
    • Florida
      • Orange City, Florida, United States, 32763
        • Completed
        • Mid Florida Hematology and Oncology Center ( Site 0109)
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Completed
        • Centricity Research Columbus Cancer Center ( Site 0111)
      • Marietta, Georgia, United States, 30060
        • Completed
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001)
      • Newnan, Georgia, United States, 30265
        • Completed
        • Southeastern Regional Medical Center ( Site 0004)
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center ( Site 0145)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-352-1745
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9552)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-712-4950
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-425-5462
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0035)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-5900
      • Pennington, New Jersey, United States, 08534
        • Recruiting
        • Capital Health Medical Center - Hopewell ( Site 0034)
        • Contact:
          • Study Coordinator
          • Phone Number: 609-303-4733
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico Comprehensive Cancer Center ( Site 0135)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-272-4946
      • Albuquerque, New Mexico, United States, 87109
        • Completed
        • New Mexico Oncology Hematology Consultants Ltd. ( Site 0123)
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St Luke's University Health Network ( Site 0017)
        • Contact:
          • Study Coordinator
          • Phone Number: 484-658-1792
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Clinical Research Institute ( Site 0147)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-955-8874
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants P.A. ( Site 0124)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-600-0913
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Cancer Center ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 281-540-7905
      • San Antonio, Texas, United States, 78229
        • Completed
        • Mays Cancer Center ( Site 0132)

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) [Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8]
  • Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
  • Has life expectancy ≥3 months
  • Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
  • Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)
  • Has adequate organ function
  • For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization
  • For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
  • For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered
  • For Maintenance only (prior to randomization): has not experienced a pneumonitis/interstitial lung disease (ILD) event during the study-specified induction

Exclusion Criteria:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
  • HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
  • Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
  • Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
  • Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications
  • Received prior treatment with a topoisomerase I inhibitor-containing ADC
  • Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has known central nervous system (CNS) metastases/carcinomatous meningitis
  • Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
  • Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy [eg, thyroxine, insulin, or physiologic corticosteroid] is allowed)
  • Has a history of (noninfectious)pneumonitis/ILD that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
  • Active infection requiring systemic therapy
  • History of allogeneic tissue/solid organ transplant

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: Maintenance Arm A: Pembrolizumab + sac-TMT

During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. Note: per investigator discretion, carboplatin AUC 5 mg/mL/min q3w or paclitaxel 175mg/m2 q3w may be administered.

During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
Biological: Pembrolizumab
Intravenous (IV) infusion
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Biological: sac-TMT
IV infusion
Other Names:
  • MK-2870
  • Sacituzumab tirumotecan
Drug: Nab-paclitaxel
Participants receive 100 mg/m^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.
Drug: Carboplatin
Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
Drug: Paclitaxel
Participants receive 200 mg/m^2 or 175 mg/m^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
Active Comparator: Maintenance Arm B: Pembrolizumab Monotherapy

During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles.

During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
Biological: Pembrolizumab
Intravenous (IV) infusion
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Drug: Nab-paclitaxel
Participants receive 100 mg/m^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.
Drug: Carboplatin
Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
Drug: Paclitaxel
Participants receive 200 mg/m^2 or 175 mg/m^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to ~50 months
OS is the time from randomization to death due to any cause.
Up to ~50 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to ~79 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)
Time Frame: Baseline and up to ~79 months
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a 30-item scale to assess the overall quality of life in cancer patients. The global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Baseline and up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)
Time Frame: Baseline and up to ~79 months
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
Baseline and up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)
Time Frame: Baseline and up to ~79 months
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
Baseline and up to ~79 months
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)
Time Frame: Baseline and up to ~79 months
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The chest pain score is based on participant responses to item 40 e (1 = "Not at All" to 4 = "Very Much").
Baseline and up to ~79 months
Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30)
Time Frame: Up to ~79 months
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. TTD in global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Up to ~79 months
TTD in Dyspnea Score (EORTC QLQ-C30 Item 8)
Time Frame: Up to ~79 months
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. TTD in dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
Up to ~79 months
Number of Participants With ≥1 Adverse Event (AE)
Time Frame: Up to ~79 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.
Up to ~79 months
Number of Participants Discontinuing from Study Therapy Due to AE(s)
Time Frame: Up to ~79 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.
Up to ~79 months
TTD in Cough Score (EORTC QLQ-LC13 Item 31)
Time Frame: Up to ~79 months
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
Up to ~79 months
TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)
Time Frame: Up to ~79 months
EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in chest pain score is based on participant responses to item 40 ("Have you had pain in your chest?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse chest pain.
Up to ~79 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Estimated)

January 12, 2029

Study Completion (Estimated)

August 15, 2031

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2870-023
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • U1111-1301-2790 (Registry Identifier: UTN)
  • jRCT2021240015 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • MK-2870-023 (Other Identifier: MSD)
  • 2023-510128-66-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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