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

Status: Recruiting
Location: See all (195) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\]

• Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology

• Has life expectancy ≥3 months

• Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation

• Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided

• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

• Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation

• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible). Note: Participants with Grade =2 neuropathy are eligible

• Has adequate organ function

• For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization

• For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit

• For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered

Locations
United States
Arkansas
CARTI Cancer Center ( Site 0006)
RECRUITING
Little Rock
California
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122)
RECRUITING
Burbank
Colorado
Exempla Lutheran Medical Center ( Site 0119)
RECRUITING
Golden
Intermountain Health St. Mary's Regional Hospital ( Site 0116)
RECRUITING
Grand Junction
Florida
Mid Florida Hematology and Oncology Center ( Site 0109)
COMPLETED
Orange City
Georgia
Centricity Research Columbus Cancer Center ( Site 0111)
COMPLETED
Columbus
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001)
COMPLETED
Marietta
Southeastern Regional Medical Center ( Site 0004)
RECRUITING
Newnan
Illinois
University of Chicago Medical Center ( Site 0145)
RECRUITING
Chicago
Minnesota
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)
RECRUITING
Minneapolis
New Mexico
New Mexico Oncology Hematology Consultants Ltd. ( Site 0123)
COMPLETED
Albuquerque
University of New Mexico Comprehensive Cancer Center ( Site 0135)
RECRUITING
Albuquerque
Pennsylvania
St Luke's University Health Network ( Site 0017)
RECRUITING
Bethlehem
Thomas Jefferson University - Clinical Research Institute ( Site 0147)
RECRUITING
Philadelphia
Texas
Oncology Consultants P.A. ( Site 0124)
RECRUITING
Houston
Mays Cancer Center ( Site 0132)
RECRUITING
San Antonio
Other Locations
Argentina
Fundacion Intecnus ( Site 0205)
RECRUITING
Bariloche
Hospital Aleman-Oncology ( Site 0202)
RECRUITING
Buenos Aires
Instituto Alexander Fleming ( Site 0203)
RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200)
RECRUITING
Mar Del Plata
Instituto Médico Río Cuarto ( Site 0204)
RECRUITING
Río Cuarto
Sanatorio Parque ( Site 0201)
RECRUITING
Rosario
Austria
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720)
RECRUITING
Linz
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710)
RECRUITING
Vienna
Klinik Hietzing ( Site 0740)
RECRUITING
Vienna
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730)
RECRUITING
Vienna
Brazil
Hospital Nossa Senhora da Conceição ( Site 0300)
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311)
RECRUITING
Porto Alegre
Hospital do Cancer de Pernambuco ( Site 0312)
RECRUITING
Recife
Instituto de Oncologia Saint Gallen ( Site 0304)
RECRUITING
Santa Cruz Do Sul
Hospital de Base de São José do Rio Preto ( Site 0310)
RECRUITING
São José Do Rio Preto
Hospital Paulistano ( Site 0307)
RECRUITING
São Paulo
Vencer Centro de Pesquisa Clínica ( Site 0309)
RECRUITING
Teresina
Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100)
RECRUITING
Kingston
Waterloo Regional Health Network (WRHN) ( Site 0153)
RECRUITING
Kitchener
McGill University Health Centre ( Site 0103)
RECRUITING
Montreal
St. Marys Hospital Center ( Site 0105)
RECRUITING
Montreal
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0106)
RECRUITING
Trois-rivières
Chile
Bradford Hill Norte ( Site 0420)
RECRUITING
Antofagasta
Bradfordhill-Clinical Area ( Site 0407)
RECRUITING
Santiago
FALP ( Site 0409)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0402)
RECRUITING
Santiago
Centro de Investigación del Maule ( Site 0419)
RECRUITING
Talca
ONCOCENTRO APYS-ACEREY ( Site 0400)
RECRUITING
Viña Del Mar
China
Beijing Cancer Hospital ( Site 2411)
RECRUITING
Beijing
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410)
RECRUITING
Beijing
Peking Union Medical College Hospital ( Site 2412)
RECRUITING
Beijing
Jilin Province Tumor Hospital-GCP office ( Site 2413)
RECRUITING
Changchun
The First Hospital of Jilin University-Oncology ( Site 2414)
RECRUITING
Changchun
The Second Xiangya Hospital of Central South University-Oncology ( Site 2418)
RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 2421)
RECRUITING
Chengdu
West China Hospital, Sichuan University ( Site 2422)
RECRUITING
Chengdu
Army Medical Center of People's Liberation Army-respiratory ( Site 2426)
RECRUITING
Chongqing
Fujian Provincial Cancer Hospital ( Site 2419)
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2416)
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University ( Site 2417)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 2407)
RECRUITING
Hangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine-Respiratory Department ( Site 2406)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital-Breast Oncology ( Site 2408)
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital-oncology of department ( Site 2415)
RECRUITING
Harbin
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 2402)
RECRUITING
Huai'an
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 2404)
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2405)
RECRUITING
Nanchang
Shanghai East Hospital ( Site 2428)
RECRUITING
Shanghai
Shanghai Pulmonary Hospital ( Site 2427)
RECRUITING
Shanghai
Taizhou Hospital of Zhejiang Province ( Site 2430)
RECRUITING
Taizhou
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 2425)
RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2409)
RECRUITING
Wenzhou
Tongji Hospital Tongji Medical,Science & Technology ( Site 2424)
ACTIVE_NOT_RECRUITING
Wuhan
The First Affiliated hospital of Xiamen University-oncology ( Site 2420)
RECRUITING
Xiamen
Northern Jiangsu People's Hospital-General Surgery Department ( Site 2403)
RECRUITING
Yangzhou
Henan Cancer Hospital-Pneumology department ( Site 2423)
RECRUITING
Zhengzhou
Colombia
Centro Cancerológico del Caribe (CECAC) ( Site 0509)
RECRUITING
Barranquilla
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0500)
RECRUITING
Bogotá
Oncologos del Occidente ( Site 0504)
RECRUITING
Pereira
Fundación Valle del Lili-Oncology CIC ( Site 0505)
RECRUITING
Santiago De Cali
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
RECRUITING
Valledupar
France
Institut de Cancérologie de l'Ouest ( Site 0908)
RECRUITING
Angers
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902)
RECRUITING
Avignon
CHD Vendee ( Site 0901)
RECRUITING
La Roche-sur-yon
Clinique Clairval ( Site 0904)
RECRUITING
Marseille
Hôpital Saint-Louis ( Site 0906)
RECRUITING
Paris
Hôpital Robert Schuman ( Site 0907)
RECRUITING
Vantoux
Germany
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1003)
RECRUITING
Berlin
GEFOS Gesellschaft f. onkologische Studien ( Site 1005)
RECRUITING
Dortmund
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1001)
RECRUITING
Essen
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1006)
RECRUITING
Gera
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1000)
RECRUITING
Lübeck
Hungary
Országos Korányi Pulmonológiai Intézet ( Site 1104)
RECRUITING
Budapest
Petz Aladar Egyetemi Oktato Korhaz ( Site 1101)
RECRUITING
Győr
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)
RECRUITING
Kecskemét
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1103)
RECRUITING
Szolnok
Reformatus Pulmonologiai Centrum ( Site 1102)
RECRUITING
Törökbálint
Zala Megyei Szent Rafael Kórház ( Site 1110)
RECRUITING
Zalaegerszeg
Ireland
St. James's Hospital ( Site 1200)
RECRUITING
Dublin
Israel
Rambam Health Care Campus-Oncology Division ( Site 1302)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 1300)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1303)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1301)
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414)
RECRUITING
Brescia
Ospedale San Martino ( Site 1407)
RECRUITING
Genova
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1404)
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 1412)
RECRUITING
Monza
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1401)
RECRUITING
Napoli
Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 1410)
RECRUITING
Pavia
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409)
RECRUITING
Rome
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1402)
RECRUITING
Rome
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1408)
RECRUITING
Rozzano
Ospedale di Circolo e Fondazione Macchi Varese-Oncology ( Site 1413)
RECRUITING
Varese
Japan
Chiba University Hospital ( Site 2517)
RECRUITING
Chiba
National Hospital Organization Kyushu Medical Center ( Site 2509)
RECRUITING
Fukuoka
Kansai Medical University Hospital ( Site 2503)
RECRUITING
Hirakata
Hirosaki University Hospital ( Site 2514)
RECRUITING
Hirosaki
Kanazawa University Hospital ( Site 2513)
RECRUITING
Kanazawa
National Cancer Center Hospital East ( Site 2501)
RECRUITING
Kashiwa
St. Marianna University Hospital ( Site 2521)
RECRUITING
Kawasaki
Saitama Prefectural Cancer Center ( Site 2512)
RECRUITING
Kitaadachi-gun
Cancer Institute Hospital of JFCR ( Site 2500)
RECRUITING
Koto
Matsusaka Municipal Hospital ( Site 2522)
RECRUITING
Matsusaka
Aichi Cancer Center ( Site 2502)
RECRUITING
Nagoya
Nagoya University Hospital ( Site 2519)
RECRUITING
Nagoya
Niigata Cancer Center Hospital ( Site 2505)
RECRUITING
Niigata
Osaka International Cancer Institute ( Site 2506)
RECRUITING
Osaka
Gunma Prefectural Cancer Center ( Site 2510)
RECRUITING
Ōta
Toho University Omori Medical Center ( Site 2520)
RECRUITING
Ōta-ku
Sendai Kousei Hospital ( Site 2507)
RECRUITING
Sendai
National Center for Global Health and Medicine ( Site 2516)
RECRUITING
Shinjuku
Takarazuka City Hospital ( Site 2508)
RECRUITING
Takarazuka
Ehime University Hospital ( Site 2511)
RECRUITING
Tōon
Fujita Health University Hospital ( Site 2515)
RECRUITING
Toyoake
National Hospital Organization Yamaguchi Ube Medical Center ( Site 2523)
RECRUITING
Ube
Kanagawa Cancer Center ( Site 2504)
RECRUITING
Yokohama
Kanagawa Cardiovascular and Respiratory Center ( Site 2518)
RECRUITING
Yokohama
Peru
Clínicas AUNA Sede Chiclayo ( Site 0604)
RECRUITING
Chiclayo
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 0602)
RECRUITING
Lima
Oncosalud-Clinical Research ( Site 0600)
RECRUITING
Lima
Clínica San Antonio ( Site 0606)
RECRUITING
Trujillo
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1503)
RECRUITING
Bydgoszcz
Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1507)
RECRUITING
Gorlice
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1513)
RECRUITING
Grudziądz
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1515)
RECRUITING
Krakow
Szpital Wojewódzki w Koszalinie. ( Site 1517)
RECRUITING
Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 1510)
RECRUITING
Poznań
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1501)
RECRUITING
Przemyśl
Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 1523)
RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1500)
RECRUITING
Warsaw
Republic of Korea
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 2106)
RECRUITING
Bupyeong-gu
Pusan National University Hospital ( Site 2100)
RECRUITING
Busan
Chungnam national university hospital-Department of Internal Medicine ( Site 2107)
RECRUITING
Daejeon
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2102)
RECRUITING
Deagu
Asan Medical Center ( Site 2105)
RECRUITING
Seoul
Korea University Guro Hospital-Internal Medicine ( Site 2103)
RECRUITING
Seoul
Kyung Hee University Hospital ( Site 2101)
RECRUITING
Seoul
Pusan National University Yangsan Hospital ( Site 2104)
RECRUITING
Yangsan
Romania
SC ONCO CARD SRL ( Site 2007)
RECRUITING
Brasov
Centrul Medical Medicover Victoria ( Site 2000)
RECRUITING
Bucharest
Lotus-Med ( Site 2009)
RECRUITING
Bucharest
Cardiomed SRL Cluj-Napoca ( Site 2002)
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2004)
RECRUITING
Craiova
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2001)
RECRUITING
Florești
Clinica Polisano ( Site 2008)
RECRUITING
Sibiu
Cabinet Medical Oncomed ( Site 2005)
RECRUITING
Timișoara
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1700)
RECRUITING
Barcelona
Hospital Insular de Gran Canaria-Oncology ( Site 1701)
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 1702)
RECRUITING
Madrid
Hospital Quirón Málaga ( Site 1704)
RECRUITING
Málaga
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1703)
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1705)
RECRUITING
Seville
Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 2207)
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital ( Site 2204)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 2205)
RECRUITING
Tainan City
Mackay Memorial Hospital-Chest Medicine ( Site 2201)
RECRUITING
Taipei
National Taiwan University Hospital-Oncology ( Site 2208)
RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 2209)
RECRUITING
Taipei City
Taoyuan General Hospital ( Site 2203)
RECRUITING
Taoyuan
Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 2202)
RECRUITING
Taoyuan District
Thailand
Faculty of Medicine Siriraj Hospital ( Site 2301)
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital ( Site 2302)
RECRUITING
Chiang Mai
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2300)
RECRUITING
Dusit
Songklanagarind hospital ( Site 2303)
RECRUITING
Hat Yai
Lampang Cancer Hospital ( Site 2304)
RECRUITING
Lampang
Faculty of Medicine - Khon Kaen University ( Site 2305)
RECRUITING
Muang
Prapokklao Hospital ( Site 2306)
RECRUITING
Mueang
Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800)
RECRUITING
Ankara
Gazi Universitesi-Oncology ( Site 1804)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1801)
RECRUITING
Ankara
Izmir Atatürk Training and Research Hospital ( Site 1810)
RECRUITING
Izmir
Memorial Kayseri Hastanesi ( Site 1805)
RECRUITING
Kayseri
Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1808)
RECRUITING
Mersin
Samsun Medical Park Hastanesi-medical oncology ( Site 1806)
RECRUITING
Samsun
Medipol Mega Universite Hastanesi-oncology ( Site 1811)
RECRUITING
Stanbul
United Arab Emirates
Burjeel Medical City ( Site 2600)
RECRUITING
Abu Dhabi
United Kingdom
St Bartholomew's Hospital ( Site 1901)
RECRUITING
London
City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)
RECRUITING
Nottingham
Torbay Hospital ( Site 1906)
RECRUITING
Torquay
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2031-02-12
Participants
Target number of participants: 851
Treatments
Experimental: Maintenance Arm A: Pembrolizumab + sac-TMT
During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
Active_comparator: Maintenance Arm B: Pembrolizumab Monotherapy
During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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