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Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Sponsor: Merck Sharp & Dohme LLC
Summary
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
Official title: Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
851
Start Date
2024-06-10
Completion Date
2031-02-12
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Intravenous (IV) infusion
sac-TMT
IV infusion
Carboplatin
Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
Paclitaxel
Participants receive 200 mg/m\^2 or 175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
Nab-paclitaxel
Participants receive 100 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.
Locations (205)
CARTI Cancer Center ( Site 0006)
Little Rock, Arkansas, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122)
Burbank, California, United States
Exempla Lutheran Medical Center ( Site 0119)
Golden, Colorado, United States
Intermountain Health St. Mary's Regional Hospital ( Site 0116)
Grand Junction, Colorado, United States
Mid Florida Hematology and Oncology Center ( Site 0109)
Orange City, Florida, United States
Centricity Research Columbus Cancer Center ( Site 0111)
Columbus, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001)
Marietta, Georgia, United States
Southeastern Regional Medical Center ( Site 0004)
Newnan, Georgia, United States
University of Chicago Medical Center ( Site 0145)
Chicago, Illinois, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)
Minneapolis, Minnesota, United States
New Mexico Oncology Hematology Consultants Ltd. ( Site 0123)
Albuquerque, New Mexico, United States
University of New Mexico Comprehensive Cancer Center ( Site 0135)
Albuquerque, New Mexico, United States
St Luke's University Health Network ( Site 0017)
Bethlehem, Pennsylvania, United States
Thomas Jefferson University - Clinical Research Institute ( Site 0147)
Philadelphia, Pennsylvania, United States
Memorial Hermann Cancer Center ( Site 0015)
Houston, Texas, United States
Oncology Consultants P.A. ( Site 0124)
Houston, Texas, United States
Mays Cancer Center ( Site 0132)
San Antonio, Texas, United States
Instituto Alexander Fleming ( Site 0203)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200)
Mar del Plata, Buenos Aires, Argentina
Instituto Médico Río Cuarto ( Site 0204)
Río Cuarto, Córdoba Province, Argentina
Fundacion Intecnus ( Site 0205)
Bariloche, Río Negro Province, Argentina
Sanatorio Parque ( Site 0201)
Rosario, Santa Fe Province, Argentina
Hospital Aleman-Oncology ( Site 0202)
Buenos Aires, Argentina
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720)
Linz, Upper Austria, Austria
Klinik Hietzing ( Site 0740)
Vienna, Austria
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730)
Vienna, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710)
Vienna, Austria
Hospital do Cancer de Pernambuco ( Site 0312)
Recife, Pernambuco, Brazil
Vencer Centro de Pesquisa Clínica ( Site 0309)
Teresina, Piauí, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição ( Site 0300)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia Saint Gallen ( Site 0304)
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Hospital de Base de São José do Rio Preto ( Site 0310)
São José do Rio Preto, São Paulo, Brazil
Hospital Paulistano ( Site 0307)
São Paulo, Brazil
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100)
Kingston, Ontario, Canada
Waterloo Regional Health Network (WRHN) ( Site 0153)
Kitchener, Ontario, Canada
St. Marys Hospital Center ( Site 0105)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0103)
Montreal, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0106)
Trois-Rivières, Quebec, Canada
Centro de Investigación del Maule ( Site 0419)
Talca, Maule Region, Chile
FALP ( Site 0409)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0402)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0407)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0400)
Viña del Mar, Región de Valparaíso, Chile
Bradford Hill Norte ( Site 0420)
Antofagasta, Chile
Beijing Cancer Hospital ( Site 2411)
Beijing, Beijing Municipality, China
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 2412)
Beijing, Beijing Municipality, China
Army Medical Center of People's Liberation Army-respiratory ( Site 2426)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital ( Site 2419)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University-oncology ( Site 2420)
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 2417)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2416)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital-oncology of department ( Site 2415)
Harbin, Heilongjiang, China
Henan Cancer Hospital-Pneumology department ( Site 2423)
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2424)
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University-Oncology ( Site 2418)
Changsha, Hunan, China
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 2402)
Huai'an, Jiangsu, China
Northern Jiangsu People's Hospital-General Surgery Department ( Site 2403)
Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2405)
Nanchang, Jiangxi, China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 2404)
Nanchang, Jiangxi, China
Jilin Province Tumor Hospital-GCP office ( Site 2413)
Changchun, Jilin, China
The First Hospital of Jilin University-Oncology ( Site 2414)
Changchun, Jilin, China
Shanghai East Hospital ( Site 2428)
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital ( Site 2427)
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 2422)
Chengdu, Sichuan, China
Sichuan Cancer hospital. ( Site 2421)
Chengdu, Sichuan, China
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 2425)
Ürümqi, Xinjiang, China
The first Affiliated Hospital, Zhejiang University School of Medicine-Respiratory Department ( Site 2406)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 2407)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital-Breast Oncology ( Site 2408)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 2430)
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2409)
Wenzhou, Zhejiang, China
Centro Cancerológico del Caribe (CECAC) ( Site 0509)
Barranquilla, Atlántico, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0500)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
Valledupar, Cesar Department, Colombia
Oncologos del Occidente ( Site 0504)
Pereira, Risaralda Department, Colombia
Fundación Valle del Lili-Oncology CIC ( Site 0505)
Cali, Valle del Cauca Department, Colombia
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0800)
Brno, Brno-mesto, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 0803)
Ostrava-Vitkovice, Ostrava Mesto, Czechia
Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 0804)
Pardubice, Pardubický kraj, Czechia
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0802)
Olomouc, Czechia
Clinique Clairval ( Site 0904)
Marseille, Bouches-du-Rhone, France
Hôpital Robert Schuman ( Site 0907)
Vantoux, Lorraine, France
Institut de Cancérologie de l'Ouest ( Site 0908)
Angers, Maine-et-Loire, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902)
Avignon, Vaucluse, France
CHD Vendee ( Site 0901)
La Roche-sur-Yon, Vendee, France
Hôpital Saint-Louis ( Site 0906)
Paris, France
GEFOS Gesellschaft f. onkologische Studien ( Site 1005)
Dortmund, North Rhine-Westphalia, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1001)
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1000)
Lübeck, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1006)
Gera, Thuringia, Germany
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1003)
Berlin, Germany
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)
Kecskemét, Bács-Kiskun county, Hungary
Petz Aladar Egyetemi Oktato Korhaz ( Site 1101)
Győr, Győr-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1103)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Reformatus Pulmonologiai Centrum ( Site 1102)
Törökbálint, Pest County, Hungary
Zala Megyei Szent Rafael Kórház ( Site 1110)
Zalaegerszeg, Zala County, Hungary
Országos Korányi Pulmonológiai Intézet ( Site 1104)
Budapest, Hungary
St. James's Hospital ( Site 1200)
Dublin, Ireland
Rambam Health Care Campus-Oncology Division ( Site 1302)
Haifa, Israel
Shaare Zedek Medical Center ( Site 1300)
Jerusalem, Israel
Rabin Medical Center ( Site 1303)
Petah Tikva, Israel
Sheba Medical Center ( Site 1301)
Ramat Gan, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1401)
Naples, Campania, Italy
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1404)
Milan, Lombardy, Italy
Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 1412)
Monza, Lombardy, Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1408)
Rozzano, Milano, Italy
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1402)
Rome, Roma, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414)
Brescia, Italy
Ospedale San Martino ( Site 1407)
Genova, Italy
Azienda Ospedaliera Maggiore della Carita ( Site 1416)
Novara, Italy
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 1410)
Pavia, Italy
Ospedale di Circolo e Fondazione Macchi Varese-Oncology ( Site 1413)
Varese, Italy
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi ( Site 1415)
Verona, Italy
Aichi Cancer Center ( Site 2502)
Nagoya, Aichi-ken, Japan
Nagoya University Hospital ( Site 2519)
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital ( Site 2515)
Toyoake, Aichi-ken, Japan
Hirosaki University Hospital ( Site 2514)
Hirosaki, Aomori, Japan
National Cancer Center Hospital East ( Site 2501)
Kashiwa, Chiba, Japan
Ehime University Hospital ( Site 2511)
Tōon, Ehime, Japan
Gunma Prefectural Cancer Center ( Site 2510)
Ōta, Gunma, Japan
Takarazuka City Hospital ( Site 2508)
Takarazuka, Hyōgo, Japan
Kanazawa University Hospital ( Site 2513)
Kanazawa, Ishikawa-ken, Japan
St. Marianna University Hospital ( Site 2521)
Kawasaki, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 2518)
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center ( Site 2504)
Yokohama, Kanagawa, Japan
Matsusaka Municipal Hospital ( Site 2522)
Matsusaka, Mie-ken, Japan
Sendai Kousei Hospital ( Site 2507)
Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 2503)
Hirakata, Osaka, Japan
National Hospital Organization Ureshino Medical Center ( Site 2524)
Ureshino, Saga-ken, Japan
Saitama Prefectural Cancer Center ( Site 2512)
Kitaadachi-gun, Saitama, Japan
Cancer Institute Hospital of JFCR ( Site 2500)
Koto, Tokyo, Japan
Toho University Omori Medical Center ( Site 2520)
Ōta-ku, Tokyo, Japan
National Center for Global Health and Medicine ( Site 2516)
Shinjuku, Tokyo, Japan
National Hospital Organization Yamaguchi Ube Medical Center ( Site 2523)
Ube, Yamaguchi, Japan
Chiba University Hospital ( Site 2517)
Chiba, Japan
National Hospital Organization Kyushu Medical Center ( Site 2509)
Fukuoka, Japan
Niigata Cancer Center Hospital ( Site 2505)
Niigata, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2506)
Osaka, Japan
Clínica San Antonio ( Site 0606)
Trujillo, La Libertad, Peru
Clínicas AUNA Sede Chiclayo ( Site 0604)
Chiclayo, Lambayeque, Peru
Oncosalud-Clinical Research ( Site 0600)
Lima, Peru
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 0602)
Lima, Peru
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1503)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1513)
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1507)
Gorlice, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1515)
Krakow, Lesser Poland Voivodeship, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 1510)
Poznań, Lower Silesian Voivodeship, Poland
Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 1523)
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1500)
Warsaw, Masovian Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1501)
Przemyśl, Podkarpackie Voivodeship, Poland
Szpital Wojewódzki w Koszalinie. ( Site 1517)
Poland, West Pomeranian Voivodeship, Poland
Centrul Medical Medicover Victoria ( Site 2000)
Bucharest, București, Romania
Cardiomed SRL Cluj-Napoca ( Site 2002)
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2001)
Florești, Cluj, Romania
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2004)
Craiova, Dolj, Romania
Cabinet Medical Oncomed ( Site 2005)
Timișoara, Timiș County, Romania
SC ONCO CARD SRL ( Site 2007)
Brasov, Romania
Lotus-Med ( Site 2009)
Bucharest, Romania
Clinica Polisano ( Site 2008)
Sibiu, Romania
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 2106)
Bupyeong-gu, Incheon, South Korea
Pusan National University Yangsan Hospital ( Site 2104)
Yangsan, Kyongsangnam-do, South Korea
Pusan National University Hospital ( Site 2100)
Busan, Pusan-Kwangyokshi, South Korea
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2102)
Deagu, Taegu-Kwangyokshi, South Korea
Chungnam national university hospital-Department of Internal Medicine ( Site 2107)
Daejeon, Taejon-Kwangyokshi, South Korea
Kyung Hee University Hospital ( Site 2101)
Seoul, South Korea
Asan Medical Center ( Site 2105)
Seoul, South Korea
Korea University Guro Hospital-Internal Medicine ( Site 2103)
Seoul, South Korea
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1703)
Santiago de Compostela, Galicia, Spain
Hospital Insular de Gran Canaria-Oncology ( Site 1701)
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Quirón Málaga ( Site 1704)
Málaga, Malaga, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1700)
Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 1702)
Madrid, Spain
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1705)
Seville, Spain
National Taiwan University Cancer Center (NTUCC) ( Site 2209)
Taipei City, Taipei, Taiwan
Taoyuan General Hospital ( Site 2203)
Taoyuan, Taoyuan, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 2207)
Kaohsiung City, Taiwan
Taichung Veterans General Hospital ( Site 2204)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2205)
Tainan, Taiwan
National Taiwan University Hospital-Oncology ( Site 2208)
Taipei, Taiwan
Mackay Memorial Hospital-Chest Medicine ( Site 2201)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 2202)
Taoyuan District, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 2301)
Bangkoknoi, Bangkok, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2300)
Dusit, Bangkok, Thailand
Prapokklao Hospital ( Site 2306)
Mueang, Changwat Chanthaburi, Thailand
Faculty of Medicine - Khon Kaen University ( Site 2305)
Muang, Changwat Khon Kaen, Thailand
Lampang Cancer Hospital ( Site 2304)
Lampang, Changwat Lampang, Thailand
Songklanagarind hospital ( Site 2303)
Hat Yai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 2302)
Chiang Mai, Thailand
Medipol Mega Universite Hastanesi-oncology ( Site 1811)
Stanbul, Istanbul, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1801)
Ankara, Turkey (Türkiye)
Gazi Universitesi-Oncology ( Site 1804)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800)
Ankara, Turkey (Türkiye)
Izmir Atatürk Training and Research Hospital ( Site 1810)
Izmir, Turkey (Türkiye)
Memorial Kayseri Hastanesi ( Site 1805)
Kayseri, Turkey (Türkiye)
Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1808)
Mersin, Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology ( Site 1806)
Samsun, Turkey (Türkiye)
Cleveland Clinic Abu Dhabi ( Site 2650)
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Burjeel Medical City ( Site 2600)
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
North West Cancer Centre ( Site 1908)
Londonderry, Derry and Strabane, United Kingdom
Torbay Hospital ( Site 1906)
Torquay, Devon, United Kingdom
St Bartholomew's Hospital ( Site 1901)
London, London, City of, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)
Nottingham, Nottinghamshire, United Kingdom