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RECRUITING
NCT06422143
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Pembrolizumab

Intravenous (IV) infusion

BIOLOGICAL

sac-TMT

IV infusion

DRUG

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.

DRUG

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.

DRUG

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