A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
Status: Active_not_recruiting
Location: See all (156) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study is that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to overall survival (OS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC).
• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
• 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.
• Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
• Life expectancy of at least 3 months.
Locations
United States
California
Kaiser Permanente - Oakland ( Site 0054)
Oakland
Kaiser Permanente - Roseville ( Site 0055)
Roseville
Kaiser Permanente - San Francisco ( Site 0056)
San Francisco
Kaiser Permanente - Santa Clara ( Site 0057)
Santa Clara
Kaiser Permanente-Kaiser Permanente ( Site 0036)
Vallejo
Kaiser Permanente - Walnut Creek ( Site 0058)
Walnut Creek
Florida
Mid Florida Hematology and Oncology Center ( Site 0005)
Orange City
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
Marietta
Michigan
University of Michigan ( Site 0009)
Ann Arbor
Missouri
Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051)
Springfield
North Dakota
Sanford Fargo Medical Center ( Site 0028)
Fargo
New Jersey
Astera Cancer Care ( Site 0032)
East Brunswick
New York
Stony Brook University-Cancer Center ( Site 0038)
Stony Brook
South Dakota
Sanford Cancer Center ( Site 0024)
Sioux Falls
Texas
John Peter Smith Hospital ( Site 0065)
Fort Worth
Millennium Research & Clinical Development ( Site 0035)
Houston
University of Texas MD Anderson ( Site 0063)
Houston
Other Locations
Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
Buenos Aires
Clinica Adventista Belgrano-Oncology ( Site 0315)
Caba.
Instituto Alexander Fleming ( Site 0307)
Ciudad Autónoma De Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303)
La Rioja
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
Río Cuarto
Instituto de Oncología de Rosario ( Site 0301)
Rosario
Canada
Cross Cancer Institute ( Site 0201)
Edmonton
Waterloo Regional Health Network (WRHN) ( Site 0207)
Kitchener
McGill University Health Centre ( Site 0204)
Montreal
Princess Margaret Cancer Centre ( Site 0203)
Toronto
China
Beijing Cancer hospital ( Site 3100)
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3107)
Beijing
The Second Xiangya Hospital of Central South University-Oncology ( Site 3104)
Changsha
Sichuan Cancer hospital. ( Site 3127)
Chengdu
West China Hospital, Sichuan University ( Site 3126)
Chengdu
Chongqing University Cancer Hospital-Medical Oncology ( Site 3128)
Chongqing
Fujian Cancer Hospital ( Site 3124)
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3102)
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 3106)
Hangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3101)
Hangzhou
Harbin Medical University Cancer Hospital ( Site 3109)
Harbin
Anhui Provincial Cancer Hospital ( Site 3132)
Hefei
Jinan Central Hospital ( Site 3113)
Jinan
Shandong Cancer Hospital ( Site 3112)
Jinan
The Second Affiliated Hospital of Nanchang University ( Site 3119)
Nanchang
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 3117)
Nanjing
Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103)
Nanning
Zhongshan Hospital of Fudan University ( Site 3133)
Shanghai
The First Affiliated Hospital of Soochow University-Respiratory Department ( Site 3118)
Suzhou
Shanxi Cancer Hospital ( Site 3114)
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 3120)
Wenzhou
Hubei Cancer Hospital ( Site 3122)
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 3121)
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 3130)
Xi'an
The First Affiliated hospital of Xiamen University ( Site 3125)
Xiamen
Henan Cancer Hospital ( Site 3105)
Zhengzhou
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0606)
Bogotá
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
Bogotá
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 0605)
Cali
IMAT S.A.S ( Site 0602)
Montería
Oncologos del Occidente ( Site 0604)
Pereira
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0601)
Valledupar
France
Clinique Clairval ( Site 1306)
Marseille
Hopitaux Universitaires Paris Centre-Hopital Cochin-Unité d'Oncologie Thoracique ( Site 1304)
Paris
Nouvel Hôpital Civil (NHC) ( Site 1302)
Strasbourg
Gustave Roussy ( Site 1303)
Villejuif
India
Artemis hospital ( Site 3307)
Gurugram
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 3302)
Mumbai
Tata Memorial Hospital-Medical Oncology ( Site 3304)
Mumbai
All India Institute of Medical Sciences-Department of medical oncology ( Site 3303)
New Delhi
Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3301)
New Delhi
Rajiv Gandhi Cancer Institute And Research Centre ( Site 3300)
New Delhi
Italy
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1802)
Bari
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1804)
Florence
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1803)
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
Roma
Japan
National Cancer Center Hospital ( Site 3408)
Chūō
Kyushu University Hospital ( Site 3400)
Fukuoka
National Hospital Organization Kyushu Cancer Center ( Site 3401)
Fukuoka
Kansai Medical University Hospital ( Site 3414)
Hirakata
Hiroshima City Hiroshima Citizens Hospital ( Site 3419)
Hiroshima
Kanazawa University Hospital ( Site 3402)
Kanazawa
St. Marianna University Hospital ( Site 3415)
Kawasaki
Saitama Prefectural Cancer Center ( Site 3417)
Kitaadachi-gun
Miyagi Cancer Center ( Site 3406)
Natori-shi
Niigata Cancer Center Hospital ( Site 3403)
Niigata
Okayama University Hospital ( Site 3404)
Okayama
Osaka Metropolitan University Hospital ( Site 3412)
Osaka
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3410)
Osaka
Gunma Prefectural Cancer Center ( Site 3413)
Ōta
Toho University Omori Medical Center ( Site 3407)
Ōta-ku
Shizuoka Cancer Center ( Site 3405)
Sunto-gun
Ehime University Hospital ( Site 3411)
Tōon
Fujita Health University Hospital ( Site 3409)
Toyoake
Kanagawa Cancer Center ( Site 3416)
Yokohama
Malaysia
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 3501)
George Town
Hospital Tengku Ampuan Afzan ( Site 3506)
Kuantan
Sarawak General Hospital-Radiotherapy Unit ( Site 3508)
Kuching
University Malaya Medical Centre ( Site 3507)
Lembah Pantai
National Cancer Institute-Radiotherapy and Oncology ( Site 3504)
Putrajaya
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0700)
Guadalajara
Arké SMO S.A. de C.V. ( Site 0706)
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Servicio de Oncología ( Site 0705)
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0704)
Oaxaca City
Oaxaca Site Management Organization S.C. ( Site 0701)
Oaxaca City
Poland
Bialostockie Centrum Onkologii ( Site 2010)
Bialystok
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
Bydgoszcz
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)
Gliwice
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
Warsaw
Republic of Korea
Pusan National University Hospital ( Site 3805)
Busan
Chungbuk National University Hospital ( Site 3804)
Cheongju-si
Keimyung University Dongsan Hospital CRC room 1 ( Site 3814)
Daegu
National Cancer Center ( Site 3803)
Goyang-si
Chungnam national university hospital ( Site 3806)
Junggu
Pusan National University Yangsan Hospital ( Site 3802)
Pusan
Seoul National University Bundang Hospital ( Site 3807)
Seongnam
Asan Medical Center ( Site 3810)
Seoul
Korea University Guro Hospital ( Site 3808)
Seoul
Samsung Medical Center ( Site 3811)
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3812)
Seoul
Ajou University Hospital ( Site 3813)
Suwon
The Catholic University Of Korea St. Vincent's Hospital ( Site 3800)
Suwon
Spain
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2323)
Huelva
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2321)
Lhospitalet De Llobregat
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2322)
Santiago De Compostela
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2324)
Seville
Sweden
Karolinska Universitetssjukhuset Solna ( Site 2401)
Stockholm
Taiwan
Changhua Christian Hospital ( Site 3904)
Changhua
National Taiwan University Hospital - Hsinchu branch ( Site 3900)
Hsinchu
Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)
Kaohsiung City
Far Eastern Memorial Hospital ( Site 3912)
New Taipei City
Taichung Veterans General Hospital-Chest ( Site 3910)
Taichung
Chi Mei Hospital - Liouying Branch ( Site 3909)
Tainan
National Cheng Kung University Hospital ( Site 3901)
Tainan
Mackay Memorial Hospital-Chest Medicine ( Site 3902)
Taipei
National Taiwan University Hospital-Oncology ( Site 3908)
Taipei
Taipei Medical University Hospital ( Site 3903)
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 3907)
Taipei City
Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 3911)
Taoyuan
Thailand
Faculty of Medicine Siriraj Hospital ( Site 4004)
Bangkoknoi
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 4006)
Dusit
Songklanagarind hospital ( Site 4003)
Hat Yai
Lampang Cancer Hospital ( Site 4000)
Lampang
Faculty of Medicine - Khon Kaen University ( Site 4002)
Muang
Maharaj Nakorn Chiang Mai Hospital ( Site 4005)
Muang
Ramathibodi Hospital ( Site 4001)
Ratchathewi
Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2504)
Adana
Ankara Bilkent Şehir Hastanesi ( Site 2500)
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)
Ankara
I.E.U. Medical Point Hastanesi-Oncology ( Site 2503)
Izmir
Viet Nam
Hanoi Oncology Hospital ( Site 4198)
Hanoi
K Hospital - National Cancer Hospital ( Site 4193)
Hanoi
National Lung Hospital-Oncology Department ( Site 4194)
Hanoi
Cho Ray Hospital ( Site 4190)
Ho Chi Minh City
Oncology Hospital ( Site 4191)
Ho Chi Minh City
Tam Anh TP.HCM General Hospital ( Site 4196)
Ho Chi Minh City
Thong Nhat Hospital ( Site 4192)
Tan Binh District
Time Frame
Start Date: 2024-06-11
Completion Date: 2030-06-14
Participants
Target number of participants: 520
Treatments
Experimental: Sacituzumab tirumotecan
Participants receive 4 mg/kg sacituzumab tirumotecan via intravenous (IV) infusion every 2 weeks (Days 1, 15, and 29 of every 6-week cycle) until discontinuation criteria is met.
Active_comparator: Pemetrexed Plus Carboplatin
Participants receive, via IV infusion, 500 mg/m2 pemetrexed every 3 weeks (Days 1 and 22 of every 6-week cycle) plus area under the curve (AUC) 5 mg/mL\*min carboplatin every 3 weeks (Days 1 and 22 of every 6-week cycle for 4 doses), then 500 mg/m2 pemetrexed every 3 weeks until discontinuation criteria is met.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC