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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)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
614
Start Date
2023-12-15
Completion Date
2030-05-27
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
IV infusion
Pembrolizumab
IV infusion
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
Locations (220)
Mayo Clinic in Arizona - Phoenix ( Site 0147)
Phoenix, Arizona, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
Burbank, California, United States
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
Grand Junction, Colorado, United States
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)
Jacksonville, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)
Marietta, Georgia, United States
The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
Louisville, Kentucky, United States
New England Cancer Specialists ( Site 0143)
Westbrook, Maine, United States
University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)
Worcester, Massachusetts, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester ( Site 0148)
Rochester, Minnesota, United States
Hattiesburg Clinic Hematology/Oncology ( Site 0104)
Hattiesburg, Mississippi, United States
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
Reno, Nevada, United States
University Hospitals Cleveland Medical Center ( Site 0119)
Cleveland, Ohio, United States
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)
Corvallis, Oregon, United States
Oncology Consultants P.A. ( Site 0129)
Houston, Texas, United States
Instituto Alexander Fleming ( Site 0306)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
Buenos Aires, Buenos Aires F.D., Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
Río Cuarto, Córdoba Province, Argentina
Instituto de Oncología de Rosario ( Site 0301)
Rosario, Santa Fe Province, Argentina
Hospital Aleman-Oncology ( Site 0300)
Buenos Aires, Argentina
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)
Port Macquarie, New South Wales, Australia
Westmead Hospital ( Site 3000)
Westmead, New South Wales, Australia
Grampians Health-Medical Oncology ( Site 3001)
Ballarat Central, Victoria, Australia
Northern Hospital ( Site 3003)
Epping, Victoria, Australia
Peninsula University Hospital ( Site 3004)
Frankston, Victoria, Australia
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Viver ( Site 0400)
Santa Maria, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)
Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 0405)
Rio de Janeiro, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)
São Paulo, Brazil
William Osler Health System ( Site 0203)
Brampton, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital ( Site 0202)
Mississauga, Ontario, Canada
McGill University Health Centre ( Site 0200)
Montreal, Quebec, Canada
Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
Talca, Maule Region, Chile
Orlandi Oncologia-Oncology ( Site 0504)
Santiago, Region M. de Santiago, Chile
FALP-UIDO ( Site 0509)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0507)
Santiago, Region M. de Santiago, Chile
Bradford Hill Norte ( Site 0516)
Antofagasta, Chile
Second Affiliated hospital of Anhui Medical University ( Site 3133)
Hefei, Anhui, China
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital ( Site 3131)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)
Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University ( Site 3123)
Zhanjiang, Guangdong, China
The Second Hospital of Hebei Medical University ( Site 3135)
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 3116)
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)
Wuhan, Hubei, China
Wuhan Union Hospital ( Site 3130)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 3106)
Wuhan, Hubei, China
Xiangyang Central Hospital-oncology department ( Site 3136)
Xiangyang, Hubei, China
The Second Xiangya Hospital of Central South University ( Site 3138)
Changsha, Hunan, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College ( Site 3112)
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)
Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital ( Site 3143)
Nanchang, Jiangxi, China
Jilin Province Tumor Hospital-oncology department ( Site 3126)
Changchun, Jilin, China
Jinan Central Hospital-oncology department ( Site 3122)
Jinan, Shandong, China
Shandong Cancer Hospital ( Site 3119)
Jinan, Shandong, China
Shanghai Changhai Hospital ( Site 3125)
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 3124)
Chengdu, Sichuan, China
Sichuan Cancer hospital. ( Site 3105)
Chengdu, Sichuan, China
The Second People's Hospital of Neijiang ( Site 3140)
Neijiang, Sichuan, China
Yunnan Province Cancer Hospital ( Site 3139)
Kunming, Yunnan, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114)
Taizhou, Zhejiang, China
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
Bogotá, Bogota D.C., Colombia
IMAT S.A.S ( Site 0602)
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente ( Site 0603)
Pereira, Risaralda Department, Colombia
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1103)
Ostrava, Ostrava Mesto, Czechia
Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 1105)
Pardubice, Pardubice Region, Czechia
Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1106)
Prague, Praha 2, Czechia
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)
Olomouc, Czechia
Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204)
Herning, Central Jutland, Denmark
Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201)
Aalborg, North Denmark, Denmark
Odense Universitetshospital ( Site 1200)
Odense C, Region Syddanmark, Denmark
Hôpital Saint Joseph-ONCOLOGY ( Site 1308)
Marseille, Bouches-du-Rhone, France
Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309)
Montpellier, Herault, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 1303)
Limoges, Limousin, France
Centre d'Oncologie de Gentilly ( Site 1301)
Nancy, Meurthe-et-Moselle, France
Centre Hospitalier de la Cote Basque ( Site 1300)
Bayonne, Pyrenees-Atlantiques, France
L HOPITAL NORD OUEST ( Site 1310)
Villefranche-sur-Saône, Rhone, France
Clinique de l'Europe-Service de pneumologie ( Site 1304)
Amiens, Somme, France
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1305)
Poitiers, Vienne, France
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik V ( Site 1409)
München, Bavaria, Germany
Klinikum Bogenhausen-Klinik für Pneumologie und Onkologische Pneumologie ( Site 1406)
München, Bavaria, Germany
Klinikum Nürnberg Nord-5. Med. Klinik ( Site 1407)
Nuremberg, Bavaria, Germany
Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 1412)
Marburg, Hesse, Germany
Medizinische Hochschule Hannover-Department of Pneumology ( Site 1411)
Hanover, Lower Saxony, Germany
Bethanien Krankenhaus Moers ( Site 1400)
Moers, North Rhine-Westphalia, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus-Medizinische Klinik A ( Site 1410)
Münster, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz- Klinik für Pneumologie ( Site 1404)
Mainz, Rhineland-Palatinate, Germany
LungenClinic Grosshansdorf-Onkologie ( Site 1401)
Großhansdorf, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1403)
Gera, Thuringia, Germany
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402)
Berlin, Germany