A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (TroFuse-019)

May 21, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

780

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: +541148277000
      • Córdoba, Argentina, X5016KEH
        • Recruiting
        • Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: +543514688200
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)
        • Contact:
          • Study Coordinator
          • Phone Number: +541149590200
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Recruiting
        • Hospital Británico de Buenos Aires-Oncology ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: +541143096400
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CVB
        • Recruiting
        • Sanatorio Británico-Clinical Oncology Department ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: 5493416575134
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: 5493416955611
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
        • Recruiting
        • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)
        • Contact:
          • Study Coordinator
          • Phone Number: 543814752113
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: 0298455200
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Recruiting
        • The Prince Charles Hospital ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: +61736470368
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital-Medical Oncology ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: 08 61526530
  • Austria
      • Vienna, Austria, 1210
        • Recruiting
        • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: 431277002237
      • Vienna, Austria, 1140
        • Recruiting
        • Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: 4319106042008
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: 43512 50480308
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: 4373276764428
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital-Thoracic Oncology ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 3 821 56 81
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: 081423351
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • Recruiting
        • VITAZ ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 3760 2926
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +551138932632
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra o Câncer ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +558440095595
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 51997292910
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +555133572296
      • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96830-180
        • Recruiting
        • Instituto de Oncologia Saint Gallen ( Site 0319)
        • Contact:
          • Study Coordinator
          • Phone Number: +55513056-8686
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733216638 ex6638
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 1798135-0180
  • Canada
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: 450-466-5000#3226
      • Montreal, Quebec, Canada, H3T 1M5
        • Recruiting
        • St. Marys Hospital Center ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-345-3511
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 5148908000x26214
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 5149341934X36675
  • Chile
    • Region M. de Santiago
      • Providencia, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224205098
      • Santiago, Region M. de Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
      • Santiago, Region M. de Santiago, Chile, 7650018
        • Recruiting
        • Clínica RedSalud Vitacura ( Site 0412)
        • Contact:
          • Study Coordinator
          • Phone Number: +56 9 8292 6243
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0410)
        • Contact:
          • Study Coordinator
          • Phone Number: +56323320850
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100010
        • Recruiting
        • Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: 86-10-88121122
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Peking Union Medical College Hospital-Thoracic surgery department ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: 86-10-69151188
      • Beijing, Beijing Municipality, China, 101109
        • Recruiting
        • Peking University People's Hospital ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: 01088326666
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital-oncology department ( Site 1314)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-83660063
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-61641821
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 1320)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13660202355
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital-henan cancer hospital ( Site 1316)
        • Contact:
          • Study Coordinator
          • Phone Number: 0371-65588178
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-87670445
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology-Thoracic Surgery ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-85351615
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University-Thoracic surgery ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89753003
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 1312)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89762112
    • Jiangsu
      • Nanjing, Jiangsu, China, 210012
        • Recruiting
        • Nanjing First Hospital ( Site 1310)
        • Contact:
          • Study Coordinator
          • Phone Number: 025-52271064
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University-Thoracic Surgery Department ( Site 1318)
        • Contact:
          • Study Coordinator
          • Phone Number: 0512-67780040
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Recruiting
        • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330)
        • Contact:
          • Study Coordinator
          • Phone Number: 0791-88695051
    • Jilin
      • Changchun, Jilin, China, 130031
        • Recruiting
        • The First Hospital of Jilin University ( Site 1324)
        • Contact:
          • Study Coordinator
          • Phone Number: +86-431-81875309
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • The Second Affiliated Hospital of Air Force Medical University ( Site 1332)
        • Contact:
          • Study Coordinator
          • Phone Number: 02984756100
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital ( Site 1321)
        • Contact:
          • Study Coordinator
          • Phone Number: +86-531-67626232
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital Fudan University ( Site 1325)
        • Contact:
          • Study Coordinator
          • Phone Number: 02131587861
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-65115006
    • Sichuan
      • Chengdu, Sichuan, China, 610042
        • Recruiting
        • Sichuan Cancer hospital. ( Site 1327)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85420156
      • Neijiang, Sichuan, China, 641000
        • Completed
        • The Second People's Hospital of Neijiang ( Site 1322)
    • Yunnan
      • Kunming, Yunnan, China, 650107
        • Recruiting
        • Yunnan Province Cancer Hospital ( Site 1315)
        • Contact:
          • Study Coordinator
          • Phone Number: 087168178106
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31009
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 1328)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-86006992
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of-Thoracic Cardiovascular Surgery Ward ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-87236114
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-88128276
      • Linhai, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province ( Site 1329)
        • Contact:
          • Study Coordinator
          • Phone Number: 0576-85199810
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • Ningbo No. 2 Hospital ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: 057483870375
  • Czechia
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: +420543134008
    • Ostrava Mesto
      • Ostrava, Ostrava Mesto, Czechia, 703 00
        • Recruiting
        • Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +420595633400
  • France
      • Paris, France, 75020
        • Recruiting
        • Hôpital Tenon ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: 33156016531
    • Finistere
      • Brest, Finistere, France, 29609
        • Recruiting
        • CHRU de Brest ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +33298223298
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • Recruiting
        • CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +33567771859
    • Haute-Normandie
      • Rouen, Haute-Normandie, France, 76000
        • Recruiting
        • CHU Charles Nicolle ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +33232888079
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87042
        • Recruiting
        • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: 33555056892
    • Nord
      • Valenciennes, Nord, France, 59304
        • Recruiting
        • Clinique Teissier Groupe ( Site 1811)
        • Contact:
          • Study Coordinator
          • Phone Number: +33327142434
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810)
        • Contact:
          • Study Coordinator
          • Phone Number: +33473278080
    • Rhone
      • Bron, Rhone, France, 69677
        • Recruiting
        • Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1809)
        • Contact:
          • Study Coordinator
          • Phone Number: +33427855594
    • Var
      • Toulon, Var, France, 83800 Cede
        • Recruiting
        • HIA Sainte Anne ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: 0033483162937
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75014
        • Recruiting
        • Groupe hospitalier Paris saint Joseph. ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: +33144123159
  • Germany
      • Berlin, Germany, 14165
        • Recruiting
        • Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1916)
        • Contact:
          • Study Coordinator
          • Phone Number: +493081021506
      • Berlin, Germany, 13585
        • Recruiting
        • Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- ( Site 1912)
        • Contact:
          • Study Coordinator
          • Phone Number: 4930130132629
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930450553412
      • Berlin, Germany, 13125
        • Recruiting
        • Evangelische Lungenklinik Berlin-Pneumologie ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930948020
    • Baden-Wurttemberg
      • Esslingen am Neckar, Baden-Wurttemberg, Germany, 73730
        • Recruiting
        • Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914)
        • Contact:
          • Study Coordinator
          • Phone Number: 71131032402
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Universitaetsklinikum Regensburg ( Site 1907)
        • Contact:
          • Study Coordinator
          • Phone Number: +499419447285
    • North Rhine-Westphalia
      • Hemer, North Rhine-Westphalia, Germany, 58675
        • Recruiting
        • Lungenklinik Hemer ( Site 1905)
        • Contact:
          • Study Coordinator
          • Phone Number: 02372 9080
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56073
        • Recruiting
        • Katholisches Klinikum Koblenz ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: 00492614964095
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig ( Site 1915)
        • Contact:
          • Study Coordinator
          • Phone Number: 00493419712600
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 1908)
        • Contact:
          • Study Coordinator
          • Phone Number: +493455591434
    • Thuringia
      • Bad Berka, Thuringia, Germany, 99437
        • Recruiting
        • Zentralklinik Bad Berka-Klinik für Hämatologie und Onkologie ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: +493645851501
      • Gera, Thuringia, Germany, 07548
        • Recruiting
        • SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1900)
        • Contact:
          • Study Coordinator
          • Phone Number: +493658282151
  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • European Interbalkan Medical Center ( Site 2007)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2310400213
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Recruiting
        • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 2006)
        • Contact:
          • Study Coordinator
          • Phone Number: +302610999791
    • Attica
      • Athens, Attica, Greece, 115 25
        • Recruiting
        • 251 Hellenic Air Force General Hospital ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2107464642
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107700220
      • Athens, Attica, Greece, 151 25
        • Recruiting
        • Athens Medical Center ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: +302106157392
      • Piraeus, Attica, Greece, 185 37
        • Recruiting
        • Metaxa Cancer Hospital of Piraeus ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +302132079225
    • Irakleio
      • Heraklion, Irakleio, Greece, 715 00
        • Recruiting
        • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2810392438
    • Thessaly
      • Larissa, Thessaly, Greece, 411 10
        • Recruiting
        • University General Hospital of Larissa-Oncology Clinic ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +302413502124
  • Hong Kong
      • Hksar, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 2255 3838
      • Kowloon, Hong Kong
        • Recruiting
        • Hong Kong United Oncology Centre ( Site 3403)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 2386 8002
      • Yau Ma Tei, Hong Kong, 999077
        • Recruiting
        • Queen Elizabeth Hospital ( Site 3402)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 3506 8888
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology Division ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-4-7776234
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 2206)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226555768
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239378086
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35307032
  • Italy
      • Bergamo, Italy, 24125
        • Recruiting
        • Humanitas Gavazzeni-ONCOLOGY ( Site 2310)
        • Contact:
          • Study Coordinator
          • Phone Number: +390354204106
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale San Martino ( Site 2313)
        • Contact:
          • Study Coordinator
          • Phone Number: +390105558918
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 2311)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226434856
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliero Universitaria di Parma ( Site 2312)
        • Contact:
          • Study Coordinator
          • Phone Number: +39521702660
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: +390382503938
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630156318
      • Trento, Italy, 38122
        • Recruiting
        • APSS- Presidio Ospedaliero S. Chiara ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: +390461902478
    • Catania
      • Misterbianco, Catania, Italy, 95045
        • Recruiting
        • Humanitas Istituto Clinico Catanese ( Site 2315)
        • Contact:
          • Study Coordinator
          • Phone Number: +3909573390167
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +393487469100
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223903829
      • Milan, Lombardy, Italy, 20142
        • Recruiting
        • San Paolo - ASST SANTI PAOLO E CARLO ( Site 2314)
        • Contact:
          • Study Coordinator
          • Phone Number: +390240222119
      • Monza, Lombardy, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +390392339285
    • Roma
      • Rome, Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 2309)
        • Contact:
          • Study Coordinator
          • Phone Number: 0652665698
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 2307)
        • Contact:
          • Study Coordinator
          • Phone Number: +390557947298
  • Japan
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center ( Site 1218)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-541-3231
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-24-547-1111
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital ( Site 1215)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-82-257-5555
      • Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital ( Site 1220)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-95-819-7200
      • Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-266-5111
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 1214)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-235-7991
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1210)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
      • Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3822-2131
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital ( Site 1219)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-23-633-1122
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center ( Site 1216)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-999-1111
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health, Japan ( Site 1217)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-93-603-1611
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital ( Site 1213)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-78-302-4321
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 1211)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital ( Site 1212)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-366-0221
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Recruiting
        • Saitama Prefectural Cancer Center ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-48-722-1111
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3813-3111
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
  • Mexico
      • Chihuahua City, Mexico, 31123
        • Recruiting
        • Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 614 455 9270
      • Chihuahua City, Mexico, 31203
        • Recruiting
        • Mediadvance Clinical ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 614 674 0705
      • Oaxaca City, Mexico, 68000
        • Recruiting
        • Oaxaca Site Management Organization S.C. ( Site 0507)
        • Contact:
          • Study Coordinator
          • Phone Number: 529515147056
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Recruiting
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0506)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 33 3044 7001
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0508)
        • Contact:
          • Study Coordinator
          • Phone Number: 5519336943
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 0509)
        • Contact:
          • Study Coordinator
          • Phone Number: 951209524
  • Netherlands
      • Groningen, Netherlands, 9728 NT
        • Recruiting
        • Martini Ziekenhuis ( Site 3460)
        • Contact:
          • Study Coordinator
          • Phone Number: 0505246311
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen ( Site 3459)
        • Contact:
          • Study Coordinator
          • Phone Number: 0503616161
      • Utrecht, Netherlands, 3543 AZ
        • Recruiting
        • Sint Antonius Ziekenhuis ( Site 3455)
        • Contact:
          • Study Coordinator
          • Phone Number: +0883201411
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Recruiting
        • Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 3453)
        • Contact:
          • Study Coordinator
          • Phone Number: +0765955349
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 BK
        • Recruiting
        • Isala, locatie Zwolle-Poli Longziekten ( Site 3454)
        • Contact:
          • Study Coordinator
          • Phone Number: +0031655804447
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZG
        • Recruiting
        • Leids Universitair Medisch Centrum-Longziekten ( Site 3451)
        • Contact:
          • Study Coordinator
          • Phone Number: 0715262950
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum ( Site 3452)
        • Contact:
          • Study Coordinator
          • Phone Number: +0107030323
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813TZ
        • Recruiting
        • Meander Medisch Centrum-Researchbureau Longgeneeskunde ( Site 3458)
        • Contact:
          • Study Coordinator
          • Phone Number: +31338507843
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +6493074949
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • Oslo universitetssykehus HF. Radiumhospitalet ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: +4722934000
    • Akershus
      • Lørenskog, Akershus, Norway, 1478
        • Recruiting
        • Akershus Universitetssykehus ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +4767960000
    • Buskerud
      • Drammen, Buskerud, Norway, 3004
        • Recruiting
        • Drammen Sykehus, Vestre Viken HF ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +4732803000
    • Oppland
      • Gjøvik, Oppland, Norway, 2819
        • Recruiting
        • Sykehuset Innlandet HF Gjøvik ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: +4791 50 62 00
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 956 754 968
      • Lima, Peru, 15036
        • Recruiting
        • Oncosalud ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 988 966 244
      • Lima, Peru, 15038
        • Recruiting
        • Instituto Neuro Cardiovascular de las Americas ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 991366612
      • Lima, Peru, 15038
        • Recruiting
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 957511783
      • Lima, Peru, Lima11
        • Recruiting
        • Hospital Nacional Edgardo Rebagliati Martins-medical oncology ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +51998870468
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 616 654 242
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 4 w Lublinie ( Site 2611)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 602405127
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225463066
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +48166775000
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +48856646732
      • Bialystok, Podlaskie Voivodeship, Poland, 15-540
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Białymstoku ( Site 2612)
        • Contact:
          • Study Coordinator
          • Phone Number: 858316522
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Active, not recruiting
        • Uniwersyteckie Centrum Kliniczne ( Site 2610)
      • Prabuty, Pomeranian Voivodeship, Poland, 82-550
        • Recruiting
        • Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 2613)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 552624328
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
        • Recruiting
        • Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2606)
        • Contact:
          • Study Coordinator
          • Phone Number: +48895322935
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Instituto Portugês de Oncologia de Coimbra Francisco Gentil-Oncologia Médica ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: (351)217229800
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: (351)225084000
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1769-001
        • Recruiting
        • Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: (351)217548085
    • Porto District
      • Matosinhos Municipality, Porto District, Portugal, 4464-513
        • Recruiting
        • UNIDADE LOCAL DE SAUDE DE MATOSINHOS-Serviço de Oncologia ( Site 2705)
        • Contact:
          • Study Coordinator
          • Phone Number: (351) 229391233
  • Romania
      • Brasov, Romania, 500052
        • Recruiting
        • SC ONCO CARD SRL ( Site 2808)
        • Contact:
          • Study Coordinator
          • Phone Number: +40268960
      • Bucharest, Romania, 077015
        • Recruiting
        • Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 2804)
        • Contact:
          • Study Coordinator
          • Phone Number: +40213161600
      • Bucharest, Romania, 013975
        • Recruiting
        • SC MNT HEALTHCARE EUROPE SRL ( Site 2811)
        • Contact:
          • Study Coordinator
          • Phone Number: +40 21 9230
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie ( Site 2807)
        • Contact:
          • Study Coordinator
          • Phone Number: +40374.278.811
    • Bucharest
      • Bucharest, Bucharest, Romania, 013823
        • Recruiting
        • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L.. ( Site 2803)
        • Contact:
          • Study Coordinator
          • Phone Number: +40319393
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Completed
        • Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2801)
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +40219368
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Completed
        • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2805)
    • Timiș County
      • Timișoara, Timiș County, Romania, 300595
        • Recruiting
        • Spitalul Clinic Municipal De Urgenta Timisoara ( Site 2806)
        • Contact:
          • Study Coordinator
          • Phone Number: +40256200048
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center-Lung Cancer Center ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +82319201694
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-3410-3453
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center-Lung Cancer Center ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +82319201694
      • Seongnam, Kyonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital-Medical Oncology ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-31-787-7071
      • Suwon, Kyonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-249-8455
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Recruiting
        • Chungbuk National University Hospital-Internal medicine ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-43-269-6015
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital CRC room 1 ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532586671
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2900)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos-Oncology Department ( Site 2904)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 913303000 x484835
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607744
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2905)
        • 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 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 928441738
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2902)
        • Contact:
          • Study Coordinator
          • Phone Number: 34914521987
  • Switzerland
      • Fribourg, Switzerland, 1708
        • Recruiting
        • HFR Fribourg - Hôpital Cantonal ( Site 3004)
        • Contact:
          • Study Coordinator
          • Phone Number: +41263062015
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Recruiting
        • CHUV (centre hospitalier universitaire vaudois) ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +41795560440
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden-Medizin ( Site 3006)
        • Contact:
          • Study Coordinator
          • Phone Number: +41812566646
    • Thurgau
      • Münsterlingen, Thurgau, Switzerland, 8596
        • Recruiting
        • Kantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 58 144 1563
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +88673121101
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital-Chest ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +886423592525x3256
      • Tainan, Taiwan, 704
        • Completed
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102)
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456x267511
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: +886287923311x13899
      • Taipei City, Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Cancer Center (NTUCC) ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456x271659
    • Taoyuan
      • Taoyuan City, Taoyuan, Taiwan, 33004
        • Recruiting
        • Taoyuan General Hospital ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633699721x8502
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3106)
        • Contact:
          • Study Coordinator
          • Phone Number: +903223444444
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • Gulhane Egitim Arastirma Hastanesi-Onkoloji ( Site 3104)
        • Contact:
          • Study Coordinator
          • Phone Number: 00903123042000
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 3101)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 (312) 305 50 00
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 3110)
        • Contact:
          • Study Coordinator
          • Phone Number: 903122536666
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3103)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 552 60 00
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3107)
        • Contact:
          • Study Coordinator
          • Phone Number: +902165666614
      • Kayseri, Turkey (Türkiye), 38039
        • Recruiting
        • Erciyes Universitesi Tıp Fakultesi Hastanesi ( Site 3111)
        • Contact:
          • Study Coordinator
          • Phone Number: 905388731881
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Freeman Hospital-Northern Centre for Cancer Care ( Site 3212)
        • Contact:
          • Study Coordinator
          • Phone Number: 01912336161
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital ( Site 3217)
        • Contact:
          • Study Coordinator
          • Phone Number: +441223 805000
    • Hillingdon
      • Northwood, Hillingdon, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Hospital ( Site 3218)
        • Contact:
          • Study Coordinator
          • Phone Number: 02038262403
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: 02073777000
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital ( Site 3219)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 (0) 300 304 7777
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
        • Contact:
          • Study Coordinator
          • Phone Number: 601-278-6499
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group-Research Department ( Site 0062)
        • Contact:
          • Study Coordinator
          • Phone Number: 479-334-2562
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Beverly Hills Cancer Center ( Site 0070)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-432-8933
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute ( Site 0040)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-582-7900
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-582-7900
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)
        • Contact:
          • Study Coordinator
          • Phone Number: 424-325-9070
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian ( Site 0096)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-764-4060
      • Orange, California, United States, 92868
        • Recruiting
        • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-734-6220
      • San Francisco, California, United States, 94115
        • Recruiting
        • San Francisco Oncology Associates ( Site 0066)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-600-1102
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Stamford Hospital ( Site 0083)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-358-8879
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida ( Site 0014)
        • Contact:
          • Study Coordinator
          • Phone Number: 904-953-3570
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Cancer Center ( Site 0038)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-674-2625
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center ( Site 0018)
        • Contact:
          • Study Coordinator
          • Phone Number: 386-960-7070
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine-Phase I ( Site 0056)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-778-1900
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital ( Site 0055)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-851-8000
      • Columbus, Georgia, United States, 31904
        • Completed
        • Centricity Research Columbus Cancer Center ( Site 0005)
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • Southeastern Regional Medical Center ( Site 0065)
        • Contact:
          • Study Coordinator
          • Phone Number: 770-400-6000
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Lewis Cancer and Research Pavilion ( Site 0063)
        • Contact:
          • Study Coordinator
          • Phone Number: 912-819-5704
      • Thomasville, Georgia, United States, 31792
        • Recruiting
        • Archbold Cancer Center ( Site 0071)
        • Contact:
          • Study Coordinator
          • Phone Number: 229-584-5417
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Completed
        • Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Accellacare of Duly ( Site 4005)
        • Contact:
          • Study Coordinator
          • Phone Number: 630-545-7760
      • Naperville, Illinois, United States, 60540
        • Completed
        • Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center at Parkview Regional Medical Center ( Site 0089)
        • Contact:
          • Study Coordinator
          • Phone Number: 260-266-6626
      • Lafayette, Indiana, United States, 47904
        • Recruiting
        • Indiana University Health Arnett Cancer Center ( Site 0076)
        • Contact:
          • Study Coordinator
          • Phone Number: 765-838-6885
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-301-4736
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)
        • Contact:
          • Study Coordinator
          • Phone Number: 225-765-7956
      • Baton Rouge, Louisiana, United States, 70805
        • Recruiting
        • LSU Health Baton Rouge North Clinic ( Site 4003)
        • Contact:
          • Study Coordinator
          • Phone Number: 225-765-7956
    • Maine
      • Westbrook, Maine, United States, 04092
        • Recruiting
        • New England Cancer Specialists ( Site 0095)
        • Contact:
          • Study Coordinator
          • Phone Number: 207-303-3300
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-425-5462
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester ( Site 0073)
        • Contact:
          • Study Coordinator
          • Phone Number: 904-953-1050
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Research - David C. Pratt Cancer Center ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-251-4400
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy South - David M Sindelar Cancer Center ( Site 0098)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-525-4928
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
        • Contact:
          • Study Coordinator
          • Phone Number: 775-982-5050
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health Morristown Medical Center ( Site 0077)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-971-7000
    • New York
      • Ithaca, New York, United States, 14850
        • Recruiting
        • Cayuga Medical Center ( Site 0086)
        • Contact:
          • Study Coordinator
          • Phone Number: 607-277-4341
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University-Cancer Center ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 631-372-7212
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital ( Site 0091)
        • Contact:
          • Study Coordinator
          • Phone Number: 914-681-0600
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-234-6161
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • Hightower Clinical, LLC ( Site 0084)
        • Contact:
          • Study Coordinator
          • Phone Number: 405-479-8331
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University ( Site 0052)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-494-0283
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)
        • Contact:
          • Study Coordinator
          • Phone Number: 717-531-0003
      • Lancaster, Pennsylvania, United States, 17601
        • Recruiting
        • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)
        • Contact:
          • Study Coordinator
          • Phone Number: 717-544-0511
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Recruiting
        • Saint Joseph's Candler Health System ( Site 4010)
        • Contact:
          • Study Coordinator
          • Phone Number: 912-819-5704
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina-Hollings Cancer Center ( Site 0045)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-792-4271
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center ( Site 0053)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-328-8800
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute- Research ( Site 0090)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-322-3295
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center Knoxville ( Site 0082)
        • Contact:
          • Study Coordinator
          • Phone Number: 865-305-9000
    • Texas
      • Houston, Texas, United States, 77090
        • Completed
        • Millennium Research & Clinical Development ( Site 0039)
    • Utah
      • Salt Lake City, Utah, United States, 84112-5500
        • Recruiting
        • Huntsman Cancer Institute ( Site 0042)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-587-7000

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

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

Inclusion Criteria:

  • Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines
  • Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy
  • Is able to undergo surgery based on opinion of investigator after consultation with surgeon
  • Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
  • Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
  • Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period
  • Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization
  • Participants who have 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
  • 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 at screening
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention

Exclusion Criteria:

  • Has one of the following tumor locations/types:

    • NSCLC involving the superior sulcus
    • Large cell neuro-endocrine cancer (LCNEC)
    • Sarcomatoid tumor
    • Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
  • Has Grade ≥2 peripheral neuropathy
  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • 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 QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
  • Has received prior neoadjuvant therapy for their current NSCLC diagnosis
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • 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 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 the 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
  • Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
  • Has a history of allogeneic tissue/solid organ transplant
  • Has not adequately recovered from major surgery or have ongoing surgical complications
  • Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pembrolizumab
Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (~42 weeks).
Biological: Pembrolizumab
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Other Names:
  • MK-3475
Drug: Cisplatin
Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase
Drug: Pemetrexed
Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.
Drug: Gemcitabine
Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.
Drug: Carboplatin
Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.
Drug: Paclitaxel
Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.
Experimental: Pembrolizumab + Sacituzumab tirumotecan
Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (~42 weeks).
Biological: Pembrolizumab
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Other Names:
  • MK-3475
Biological: Sacituzumab tirumotecan
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
Other Names:
  • SKB264
  • MK-2870
  • sac-TMT
Drug: Rescue medication
Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to ~ 93 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Up to ~ 93 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~ 118 months
OS is defined as the time from randomization to death due to any cause.
Up to ~ 118 months
Distant metastasis-free survival (DMFS) as assessed by investigator
Time Frame: Up to ~ 118 months
DMFS is defined as the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Up to ~ 118 months
Disease-Free Survival (DFS) as assessed by investigator
Time Frame: Up to ~ 118 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Up to ~ 118 months
Lung Cancer Specific Survival (LCSS)
Time Frame: Up to ~ 118 months
LCSS is defined as the time from randomization to the date of death due to lung cancer.
Up to ~ 118 months
Number of Participants Who Discontinue Study Intervention Due to AEs
Time Frame: Up to ~ 118 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. The percentage of participants who discontinue study treatment due to an AE will be presented.
Up to ~ 118 months
Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)
Time Frame: Baseline and up to ~118 months
The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is a psychometrically and clinically validated instrument appropriate for assessing the health-related quality of life (HRQoL) of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for the global health status or QoL a higher value indicates a better level of function.
Baseline and up to ~118 months
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)
Time Frame: Baseline and up to ~118 months
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all physical functional scales, a higher value indicates a better level of function.
Baseline and up to ~118 months
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)
Time Frame: Baseline and up to ~118 months
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all role functional scales, a higher value indicates a better level of function.
Baseline and up to ~118 months
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)
Time Frame: Baseline and up to ~118 months
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for symptom scales such as dyspnea, a higher value indicates increased severity of symptoms.
Baseline and up to ~118 months
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)
Time Frame: Baseline and up to ~118 months
The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for cough, a higher value indicates increased severity of symptoms.
Baseline and up to ~118 months
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
Time Frame: Baseline and up to ~118 months
The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for chest pain, a higher value indicates increased severity of symptoms.
Baseline and up to ~118 months
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to ~ 118 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 ~ 118 months

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

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

Helpful Links

Study record dates

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

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Estimated)

February 21, 2034

Study Completion (Estimated)

October 23, 2034

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2870-019
  • MK-2870-019 (Other Identifier: MSD)
  • jRCT2021240020 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • U1111-1297-4260 (Other Identifier: UTN)
  • 2023-508012-35-00 (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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