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RECRUITING
NCT06170788
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

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

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

And 120 more locations on ClinicalTrials.gov