Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) (TroFuse-007)

May 27, 2026 updated by: Merck Sharp & Dohme LLC

A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.

All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

614

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 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +541148277000
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 9 011-3221-8900
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1280AEB
        • Recruiting
        • Hospital Británico de Buenos Aires-Oncology ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +541143096807
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5800ALB
        • Recruiting
        • Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
        • Contact:
          • Study Coordinator
          • Phone Number: +54351153819050
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Recruiting
        • Instituto de Oncología de Rosario ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +549-341-5778394
  • Australia
    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • Recruiting
        • Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +61265801820
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital ( Site 3000)
        • Contact:
          • Study Coordinator
          • Phone Number: +61247343500
    • Victoria
      • Ballarat Central, Victoria, Australia, 3350
        • Completed
        • Grampians Health-Medical Oncology ( Site 3001)
      • Epping, Victoria, Australia, 3076
        • Recruiting
        • Northern Hospital ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +61384058715
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Recruiting
        • Instituto Nacional de Câncer - INCA ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +552132076564
      • São Paulo, Brazil, 04014-012
        • Recruiting
        • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +551144500300
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 51 3214 8151
      • Santa Maria, Rio Grande do Sul, Brazil, 97015-450
        • Recruiting
        • Clinica Viver ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +5555 30267720
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733216637
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: +551732015054
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • William Osler Health System ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: 905-494-2120
      • Mississauga, Ontario, Canada, L5M 2N1
        • Recruiting
        • Trillium Health Partners - Credit Valley Hospital ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 905-813-1100x4299
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Active, not recruiting
        • McGill University Health Centre ( Site 0200)
  • Chile
      • Antofagasta, Chile, 1263521
        • Recruiting
        • Bradford Hill Norte ( Site 0516)
        • Contact:
          • Study Coordinator
          • Phone Number: 56442023631
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Recruiting
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: 56947532700
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500713
        • Recruiting
        • Orlandi Oncologia-Oncology ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: 56226057491
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0509)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0507)
        • Contact:
          • Study Coordinator
          • Phone Number: 56229490970
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Completed
        • Second Affiliated hospital of Anhui Medical University ( Site 3133)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Active, not recruiting
        • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)
      • Beijing, Beijing Municipality, China, 100730
        • Active, not recruiting
        • Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital ( Site 3131)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-83660063
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)
        • Contact:
          • Study Coordinator
          • Phone Number: 0592-2137262
    • Guangdong
      • Guangzhou, Guangdong, China, 510140
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)
        • Contact:
          • Study Coordinator
          • Phone Number: 8620-81568636
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)
        • Contact:
          • Study Coordinator
          • Phone Number: 020- 61641575
      • Zhanjiang, Guangdong, China, 524004
        • Completed
        • Affiliated Hospital of Guangdong Medical University ( Site 3123)
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University ( Site 3135)
        • Contact:
          • Study Coordinator
          • Phone Number: 031166003872
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Active, not recruiting
        • Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital ( Site 3116)
        • Contact:
          • Study Coordinator
          • Phone Number: 4000371818
    • Hubei
      • Wuhan, Hubei, China, 430048
        • Recruiting
        • Wuhan Union Hospital ( Site 3130)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-85726114
      • Wuhan, Hubei, China, 430000
        • Active, not recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)
      • Wuhan, Hubei, China, 430079
        • Active, not recruiting
        • Hubei Cancer Hospital ( Site 3106)
      • Xiangyang, Hubei, China, 441106
        • Active, not recruiting
        • Xiangyang Central Hospital-oncology department ( Site 3136)
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University ( Site 3138)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-85295888
    • Jiangsu
      • Wuxi, Jiangsu, China, 214122
        • Active, not recruiting
        • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)
      • Xuzhou, Jiangsu, China, 221002
        • Completed
        • The Affiliated Hospital of Xuzhou Medical College ( Site 3112)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Active, not recruiting
        • The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)
      • Nanchang, Jiangxi, China, 330029
        • Active, not recruiting
        • Jiangxi Provincial Cancer Hospital ( Site 3143)
      • Nanchang, Jiangxi, China, 330006
        • Active, not recruiting
        • The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)
    • Jilin
      • Changchun, Jilin, China, 130000
        • Active, not recruiting
        • Jilin Province Tumor Hospital-oncology department ( Site 3126)
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital-oncology department ( Site 3122)
        • Contact:
          • Study Coordinator
          • Phone Number: 0531-55739999
      • Jinan, Shandong, China, 250117
        • Active, not recruiting
        • Shandong Cancer Hospital ( Site 3119)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200082
        • Active, not recruiting
        • Shanghai Changhai Hospital ( Site 3125)
    • Sichuan
      • Chengdu, Sichuan, China, 610042
        • Completed
        • Sichuan Cancer hospital. ( Site 3105)
      • Chengdu, Sichuan, China, 610041
        • Active, not recruiting
        • West China Hospital, Sichuan University ( Site 3124)
      • Neijiang, Sichuan, China, 641099
        • Active, not recruiting
        • The Second People's Hospital of Neijiang ( Site 3140)
    • Yunnan
      • Kunming, Yunnan, China, 650107
        • Active, not recruiting
        • Yunnan Province Cancer Hospital ( Site 3139)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-86960497
      • Hangzhou, Zhejiang, China, 310003
        • Active, not recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
      • Taizhou, Zhejiang, China, 317000
        • Active, not recruiting
        • Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114)
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: 3219198898
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 (3135342052)
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Recruiting
        • Oncologos del Occidente ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: 573002558656
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 588 443 666
    • Ostrava Mesto
      • Ostrava, Ostrava Mesto, Czechia, 703 00
        • Recruiting
        • Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 595 633 400
    • Pardubice Region
      • Pardubice, Pardubice Region, Czechia, 532 03
        • Recruiting
        • Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +420466016436
    • Praha 2
      • Prague, Praha 2, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224962143
  • Denmark
    • Central Jutland
      • Herning, Central Jutland, Denmark, 7400
        • Recruiting
        • Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 78430453
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 97660000
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +4523612809
  • France
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13008
        • Recruiting
        • Hôpital Saint Joseph-ONCOLOGY ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +33491806500
    • Herault
      • Montpellier, Herault, France, 34298
        • Recruiting
        • Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: +33467613100
    • Limousin
      • Limoges, Limousin, France, 87042
        • Recruiting
        • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +33555056892
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Recruiting
        • Centre d'Oncologie de Gentilly ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: 0033355685518
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64109
        • Recruiting
        • Centre Hospitalier de la Côte Basque ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: 33559443172
    • Rhone
      • Villefranche-sur-Saône, Rhone, France, 69655
        • Recruiting
        • L HOPITAL NORD OUEST ( Site 1310)
        • Contact:
          • Study Coordinator
          • Phone Number: +33642346915
    • Somme
      • Amiens, Somme, France, 80000
        • Recruiting
        • Clinique de l'Europe-Service de pneumologie ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 00 33 3 23 06 72 24
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: 00330516604212
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930450553044
    • Bavaria
      • München, Bavaria, Germany, 81925
        • Recruiting
        • Klinikum Bogenhausen-Klinik für Pneumologie und Onkologische Pneumologie ( Site 1406)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049892704316
      • München, Bavaria, Germany, 80336
        • Completed
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik V ( Site 1409)
      • Nuremberg, Bavaria, Germany, 90419
        • Recruiting
        • Klinikum Nürnberg Nord-5. Med. Klinik ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 9113982674
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Recruiting
        • Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 1412)
        • Contact:
          • Study Coordinator
          • Phone Number: +4964215861819
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover-Department of Pneumology ( Site 1411)
        • Contact:
          • Study Coordinator
          • Phone Number: 49 511 532 6553
    • North Rhine-Westphalia
      • Moers, North Rhine-Westphalia, Germany, 47441
        • Recruiting
        • Bethanien Krankenhaus Moers ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 2841 200 2297
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus-Medizinische Klinik A ( Site 1410)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 251 83-52712
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • Universitätsmedizin Johannes Gutenberg Universität Mainz- Klinik für Pneumologie ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +496131177031
    • Schleswig-Holstein
      • Großhansdorf, Schleswig-Holstein, Germany, 22927
        • Recruiting
        • LungenClinic Grosshansdorf-Onkologie ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 4102 6012421
    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • Recruiting
        • SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: 00493658287758
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1810)
        • Contact:
          • Study Coordinator
          • Phone Number: +390352673687
      • Catanzaro, Italy, 88100
        • Recruiting
        • AOU Renato Dulbecco ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +390961883221
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi ( Site 1809)
        • Contact:
          • Study Coordinator
          • Phone Number: +390557947298
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630154844
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Recruiting
        • Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +390805555442
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: +390543739100
    • Friuli Venezia Giulia
      • Udine, Friuli Venezia Giulia, Italy, 33100
        • Recruiting
        • P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +390432552751
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223903813
  • Japan
      • Fukuoka, Japan, 810-8563
        • Recruiting
        • National Hospital Organization Kyushu Medical Center ( Site 3416)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-852-0700
      • Kumamoto, Japan, 861-4193
        • Recruiting
        • Saiseikai Kumamoto Hospital ( Site 3419)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-96-351-8000
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3414)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital ( Site 3411)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-562-93-2111
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Recruiting
        • Hirosaki University Hospital ( Site 3429)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-172-33-5111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 3403)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center ( Site 3415)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-999-1111
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center ( Site 3417)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-541-3231
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 3418)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center ( Site 3402)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-276-38-0771
    • Hyōgo
      • Himeji, Hyōgo, Japan, 670-8520
        • Recruiting
        • National Hospital Organization Himeji Medical Center ( Site 3426)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-79-225-3211
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital ( Site 3428)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-19-613-7111
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 3421)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 3408)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
      • Yokohama, Kanagawa, Japan, 221-0855
        • Recruiting
        • Yokohama Municipal Citizen's Hospital ( Site 3425)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-316-4580
    • Mie-ken
      • Matsusaka, Mie-ken, Japan, 515-8544
        • Recruiting
        • Saiseikai Matsusaka Municipal Hospital ( Site 3422)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-598-23-1515
    • Miyagi
      • Sendai, Miyagi, Japan, 981-0914
        • Recruiting
        • Sendai Kousei Hospital ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-728-8000
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 3424)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-717-7000
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 3412)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital ( Site 3413)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-683-1221
    • Saga-ken
      • Ureshino, Saga-ken, Japan, 843-0393
        • Recruiting
        • National Hospital Organization Ureshino Medical Center ( Site 3427)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-954-43-1120
    • Saitama
      • Niigata, Saitama, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital ( Site 3409)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-266-5111
    • Shizuoka
      • Suntogun, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center ( Site 3410)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-55-989-5222
    • Tochigi
      • Shimotsugagun, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-282-86-1111
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8677
        • Recruiting
        • Tokyo Metropolitan Komagome Hospital ( Site 3405)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3823-2101
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 3404)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 3407)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
      • Shinjuku, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine ( Site 3406)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3202-7181
      • Ōta-ku, Tokyo, Japan, 143-8541
        • Recruiting
        • Toho University Omori Medical Center ( Site 3420)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3762-4151
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-0241
        • Recruiting
        • National Hospital Organization Yamaguchi Ube Medical Center ( Site 3423)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-836-58-2300
  • Mexico
      • Oaxaca City, Mexico, 68000
        • Recruiting
        • Oaxaca Site Management Organization S.C. ( Site 0718)
        • Contact:
          • Study Coordinator
          • Phone Number: +529511301554
      • Puebla City, Mexico, 72530
        • Recruiting
        • Clinica Integral Internacional de Oncología ( Site 0714)
        • Contact:
          • Study Coordinator
          • Phone Number: +522223555576
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Recruiting
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0715)
        • Contact:
          • Study Coordinator
          • Phone Number: 3330447001
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11819
        • Recruiting
        • Higiea Oncologia ( Site 0721)
        • Contact:
          • Study Coordinator
          • Phone Number: 5552731712
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Completed
        • Axis Heilsa S. de R.L. de C.V. ( Site 0719)
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78200
        • Recruiting
        • Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0713)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 444 585 2263
  • Netherlands
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Recruiting
        • Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031765955349
      • Tilburg, North Brabant, Netherlands, 5022 GC
        • Recruiting
        • ETZ Elisabeth-Department of Pulmonary Diseases ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031132213101
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Recruiting
        • Isala, locatie Zwolle-Poli Longziekten ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031886243254
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0851)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 956754968
      • Lima, Peru, 15038
        • Recruiting
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0850)
        • Contact:
          • Study Coordinator
          • Phone Number: +51940238282
      • Lima, Peru, Lima 31
        • Recruiting
        • Hospital Cayetano Heredia-Oncology ( Site 0855)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 986981097
      • Lima, Peru, 15047
        • Recruiting
        • Instituto Neuro Cardiovascular de las Americas ( Site 0856)
        • Contact:
          • Study Coordinator
          • Phone Number: +51991366612
    • Ariqipa
      • Arequipa, Ariqipa, Peru, 15036
        • Recruiting
        • Clinica Vallesur - AUNA ( Site 0854)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 926 938 398
    • Muni Metro de Lima
      • Surquillo, Muni Metro de Lima, Peru, 15038
        • Recruiting
        • Detecta Clínica ( Site 0853)
        • Contact:
          • Study Coordinator
          • Phone Number: +51992783190
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 523743589
      • Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland, 86-300
        • Active, not recruiting
        • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 2013)
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Completed
        • Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2016)
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-826
        • Recruiting
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 2015)
        • Contact:
          • Study Coordinator
          • Phone Number: 12 646 82 85
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225462248
      • Warsaw, Masovian Voivodeship, Poland, 01-138
        • Recruiting
        • Instytut Gruźlicy i Chorób Płuc w Warszawie-3rd Dep of Lung Diseases and Oncology ( Site 2011)
        • Contact:
          • Study Coordinator
          • Phone Number: 00 48 22 431 22 79
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 16 677 55 10
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
        • Recruiting
        • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 2018)
        • Contact:
          • Study Coordinator
          • Phone Number: +48895322978
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-549
        • Recruiting
        • SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital ( Site 2012)
        • Contact:
          • Study Coordinator
          • Phone Number: +48602181049
  • Portugal
      • Lisbon, Portugal, 1350-352
        • Recruiting
        • Hospital CUF - Tejo ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: +351213926100
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1099-023
        • Recruiting
        • Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 2104)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217229800
      • Lisbon, Lisbon District, Portugal, 1769-001
        • Recruiting
        • Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217805000
    • Madeira
      • Funchal, Madeira, Portugal, 9004-514
        • Recruiting
        • Hospital Dr. Nélio Mendonça ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: +351291705600
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Completed
        • Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 2103)
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center-Lung Cancer Center ( Site 3805)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-3010-5419
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-3410-3453
    • Kang-won-do
      • Wŏnju, Kang-won-do, South Korea, 26426
        • Completed
        • Wonju Severance Christian Hospital ( Site 3808)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center ( Site 3801)
        • Contact:
          • Study Coordinator
          • Phone Number: +82319200406
      • Suwon, Kyonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3800)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-249-7744
      • Suwon, Kyonggi-do, South Korea, 16499
        • Completed
        • Ajou University Hospital-Hematology-Oncology ( Site 3806)
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Recruiting
        • Chungbuk National University Hospital-Internal medicine ( Site 3804)
        • 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 3807)
        • Contact:
          • Study Coordinator
          • Phone Number: 82532586671
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Oncology ( Site 2330)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital La Princesa ( Site 2338)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915202200
      • Santa Cruz de Tenerife, Spain, 38010
        • Recruiting
        • Hospital Universitario Nuestra Senora de la Candelaria ( Site 2339)
        • Contact:
          • Study Coordinator
          • Phone Number: 922602020
      • Seville, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2337)
        • Contact:
          • Study Coordinator
          • Phone Number: +34955013068
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Recruiting
        • Hospital Jerez de la Frontera-UGC Oncología ( Site 2333)
        • Contact:
          • Study Coordinator
          • Phone Number: +3485681420
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2335)
        • Contact:
          • Study Coordinator
          • Phone Number: 34981178000x292872
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2331)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
    • Malaga
      • Málaga, Malaga, Spain, 29011
        • Recruiting
        • H.R.U Malaga - Hospital General ( Site 2332)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 95 130 81 30
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2336)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961114229
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital - Hsinchu branch ( Site 3901)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-972-651-703
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung ( Site 3902)
        • Contact:
          • Study Coordinator
          • Phone Number: 88677317123
      • Kaohsiung City, Taiwan, 807
        • Completed
        • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904)
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University Shuang Ho Hospital ( Site 3912)
        • Contact:
          • Study Coordinator
          • Phone Number: +886970746943
      • Taichung, Taiwan, 40705
        • Completed
        • Taichung Veterans General Hospital-Chest ( Site 3905)
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903)
        • Contact:
          • Study Coordinator
          • Phone Number: 88662353535
      • Tainan, Taiwan, 71004
        • Recruiting
        • Chi Mei Medical Center ( Site 3915)
        • Contact:
          • Study Coordinator
          • Phone Number: +886980195306
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 3906)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456x267511
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital ( Site 3909)
        • Contact:
          • Study Coordinator
          • Phone Number: +886975835146
    • Tainan
      • Tainan, Tainan, Taiwan, 73657
        • Recruiting
        • Chi Mei Hospital - Liouying Branch ( Site 3908)
        • Contact:
          • Study Coordinator
          • Phone Number: +886963051211
    • Taipei
      • Taipei City, Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Cancer Center (NTUCC) ( Site 3907)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456x267511
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 4001)
        • Contact:
          • Study Coordinator
          • Phone Number: +6653935480
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 4000)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624194489
      • Pathumwan, Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University ( Site 4003)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622564533
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507)
        • Contact:
          • Study Coordinator
          • Phone Number: +905056166338
      • Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2506)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123360909
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123052841
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 5067521275
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi ( Site 2500)
        • Contact:
          • Study Coordinator
          • Phone Number: +903125526000
      • Denizli, Turkey (Türkiye), 20070
        • Recruiting
        • Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre-Oncolgyy-Hematology ( Site 2510)
        • Contact:
          • Study Coordinator
          • Phone Number: 0090 258 296 5142
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +902166065200
      • Samsun, Turkey (Türkiye), 55139
        • Recruiting
        • Ondokuz Mayıs Universitesi ( Site 2509)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 362 312 1919
    • Istanbul
      • Stanbul, Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Medipol Mega Universite Hastanesi-oncology ( Site 2508)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 5325280486
    • Kayseri
      • Talas, Kayseri, Turkey (Türkiye), 38039
        • Recruiting
        • Erciyes University ( Site 2511)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 207 666 6270
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: 0090 232 390 43 34
  • United Kingdom
    • England
      • London, England, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 0207 794 0500
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Recruiting
        • Queen Alexandra Hospital-Oncology Department ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: 023 9228 6000 x4078
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • Recruiting
        • Kent and Canterbury Hospital-Oncology Research ( Site 2606)
        • Contact:
          • Study Coordinator
          • Phone Number: 01227 866393
    • London, City of
      • London, London, City of, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605)
        • Contact:
          • Study Coordinator
          • Phone Number: 0207 188 2006
    • Middlesbrough
      • Central Middlesbrough, Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • James Cook University Hospital ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +4401642837193
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic in Arizona - Phoenix ( Site 0147)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-342-4800
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
        • Contact:
          • Study Coordinator
          • Phone Number: 818-840-0921
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-298-7638
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)
        • Contact:
          • Study Coordinator
          • Phone Number: 904-953-9945
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Completed
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-562-3919
    • Maine
      • Westbrook, Maine, United States, 04092
        • Recruiting
        • New England Cancer Specialists ( Site 0143)
        • Contact:
          • Study Coordinator
          • Phone Number: 207-303-3424
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Completed
        • University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
        • Contact:
          • Study Coordinator
          • Phone Number: 651-241-7025
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester ( Site 0148)
        • Contact:
          • Study Coordinator
          • Phone Number: 507-538-1665
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic Hematology/Oncology ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 601-261-1700
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
        • Contact:
          • Study Coordinator
          • Phone Number: 775-982-5050
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Completed
        • University Hospitals Cleveland Medical Center ( Site 0119)
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)
        • Contact:
          • Study Coordinator
          • Phone Number: 541-768-4950
    • Texas
      • Houston, Texas, United States, 77030
        • Completed
        • Oncology Consultants P.A. ( Site 0129)
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Active, not recruiting
        • Thong Nhat Hospital ( Site 4170)
      • Ho Chi Minh City, Vietnam, 700000
        • Active, not recruiting
        • Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 4173)
      • Hà Nội, Vietnam, 100000
        • Active, not recruiting
        • K Hospital - National Cancer Hospital ( Site 4174)
    • Hanoi
      • Hanoi, Hanoi, Vietnam, 100000
        • Active, not recruiting
        • National Lung Hospital-Oncology Department ( Site 4175)
      • Hanoi, Hanoi, Vietnam, 100000
        • Active, not recruiting
        • Tam Anh General Hospital ( Site 4179)
      • Ho Chi Minh, Hanoi, Vietnam, 700000
        • Active, not recruiting
        • Cho Ray Hospital ( Site 4171)

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 or nonsquamous NSCLC

    • Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
    • Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
    • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
    • A life expectancy of at least 3 months.
    • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Has Grade ≥2 peripheral neuropathy.
  • 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 clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
  • Received prior systemic anticancer therapy for their metastatic NSCLC.
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Received radiation therapy to the lung that is >30 Gy 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. Administration of killed vaccines are allowed.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
  • Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • Active infection requiring systemic therapy
  • Concurrent active Hepatitis B and Hepatitis C virus infection.
  • Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • History of allogeneic tissue/solid organ transplant.
  • Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pembrolizumab
Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Drug: Supportive care measures
Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions
Experimental: Pembrolizumab + Sacituzumab tirumotecan
Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Biological: Sacituzumab tirumotecan
IV infusion
Other Names:
  • SKB264
  • MK-2870
Drug: Supportive care measures
Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 49 months
OS is defined as the time from randomization to death from any cause.
Up to approximately 49 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score
Time Frame: Baseline and up to approximately 77 months
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Baseline and up to approximately 77 months
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
Time Frame: Baseline and up to approximately 77 months
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Baseline and up to approximately 77 months
Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score
Time Frame: Baseline and up to approximately 77 months
Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Baseline and up to approximately 77 months
Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score
Time Frame: Baseline and up to approximately 77 months
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
Baseline and up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30)
Time Frame: Up to approximately 77 months
The TTD in GHS/QOL score (EORTC QLQ-C30 Items 29 and 30) will be presented. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD as assessed based on a negative change (decrease in score) from Baseline in GHS/QOL score. A longer TTD indicates a better outcome.
Up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
Time Frame: Up to approximately 77 months
The TTD in Dyspnea score (EORTC QLQ-C30 Item 8) will be presented. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31).
Time Frame: Up to approximately 77 months
The TTD in Cough score (EORTC QLQ-LC13 Item 31) will be presented. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Up to approximately 77 months
Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)
Time Frame: Up to approximately 77 months
The TTD in Chest Pain score (EORTC QLQ-LC13 Item 40) will be presented. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Up to approximately 77 months
Percentage of Participants That Experience at Least 1 Adverse Event
Time Frame: Up to approximately 77 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be presented.
Up to approximately 77 months
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 77 months
The percentage of participants who discontinue study treatment due to an AE will be presented.
Up to approximately 77 months
Progression free survival (PFS)
Time Frame: Up to approximately 49 months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first
Up to approximately 49 months
Objective Response (OR)
Time Frame: Up to approximately 49 months
The OR is defined as a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.
Up to approximately 49 months
Duration of Response (DOR)
Time Frame: Up to approximately 49 months
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Up to approximately 49 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)

December 15, 2023

Primary Completion (Estimated)

January 25, 2028

Study Completion (Estimated)

May 27, 2030

Study Registration Dates

First Submitted

December 3, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2870-007
  • MK-2870-007 (Other Identifier: MSD)
  • 2023-503376-24-00 (Other Identifier: EU CT)
  • jRCT2051240089 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • U1111-1287-1395 (Registry Identifier: UTN)

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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