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: Recruiting
Location: See all (155) 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 are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and 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)
RECRUITING
Oakland
Kaiser Permanente - Roseville ( Site 0055)
RECRUITING
Roseville
Kaiser Permanente - San Francisco ( Site 0056)
RECRUITING
San Francisco
Kaiser Permanente - Santa Clara ( Site 0057)
RECRUITING
Santa Clara
Kaiser Permanente-Kaiser Permanente ( Site 0036)
RECRUITING
Vallejo
Kaiser Permanente - Walnut Creek ( Site 0058)
RECRUITING
Walnut Creek
Florida
Mid Florida Hematology and Oncology Center ( Site 0005)
RECRUITING
Orange City
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
COMPLETED
Marietta
Michigan
University of Michigan ( Site 0009)
RECRUITING
Ann Arbor
Missouri
Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051)
RECRUITING
Springfield
North Dakota
Sanford Fargo Medical Center ( Site 0028)
RECRUITING
Fargo
New Jersey
Astera Cancer Care ( Site 0032)
RECRUITING
East Brunswick
New York
Stony Brook University-Cancer Center ( Site 0038)
RECRUITING
Stony Brook
South Dakota
Sanford Cancer Center ( Site 0024)
RECRUITING
Sioux Falls
Texas
Millennium Research & Clinical Development ( Site 0035)
COMPLETED
Houston
University of Texas MD Anderson ( Site 0063)
RECRUITING
Houston
Other Locations
Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
RECRUITING
Buenos Aires
Clinica Adventista Belgrano-Oncology ( Site 0315)
RECRUITING
Caba.
Instituto Alexander Fleming ( Site 0307)
RECRUITING
Ciudad Autónoma De Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303)
RECRUITING
La Rioja
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
RECRUITING
Río Cuarto
Instituto de Oncología de Rosario ( Site 0301)
RECRUITING
Rosario
Canada
Cross Cancer Institute ( Site 0201)
RECRUITING
Edmonton
Waterloo Regional Health Network (WRHN) ( Site 0207)
RECRUITING
Kitchener
McGill University Health Centre ( Site 0204)
RECRUITING
Montreal
Princess Margaret Cancer Centre ( Site 0203)
RECRUITING
Toronto
China
Beijing Cancer hospital ( Site 3100)
RECRUITING
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3107)
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University-Oncology ( Site 3104)
RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 3127)
RECRUITING
Chengdu
West China Hospital, Sichuan University ( Site 3126)
RECRUITING
Chengdu
Chongqing University Cancer Hospital-Medical Oncology ( Site 3128)
RECRUITING
Chongqing
Fujian Cancer Hospital ( Site 3124)
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3102)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 3106)
RECRUITING
Hangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3101)
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital ( Site 3109)
RECRUITING
Harbin
Anhui Provincial Cancer Hospital ( Site 3132)
RECRUITING
Hefei
Jinan Central Hospital ( Site 3113)
RECRUITING
Jinan
Shandong Cancer Hospital ( Site 3112)
RECRUITING
Jinan
The Second Affiliated Hospital of Nanchang University ( Site 3119)
COMPLETED
Nanchang
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 3117)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103)
RECRUITING
Nanning
Zhongshan Hospital of Fudan University ( Site 3133)
RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University-Respiratory Department ( Site 3118)
COMPLETED
Suzhou
Shanxi Cancer Hospital ( Site 3114)
RECRUITING
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 3120)
RECRUITING
Wenzhou
Hubei Cancer Hospital ( Site 3122)
RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 3121)
RECRUITING
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 3130)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University ( Site 3125)
RECRUITING
Xiamen
Henan Cancer Hospital ( Site 3105)
RECRUITING
Zhengzhou
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0606)
RECRUITING
Bogotá
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
RECRUITING
Bogotá
IMAT S.A.S ( Site 0602)
RECRUITING
Montería
Oncologos del Occidente ( Site 0604)
RECRUITING
Pereira
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 0605)
RECRUITING
Santiago De Cali
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0601)
RECRUITING
Valledupar
France
Clinique Clairval ( Site 1306)
RECRUITING
Marseille
Hopitaux Universitaires Paris Centre-Hopital Cochin-Unité d'Oncologie Thoracique ( Site 1304)
RECRUITING
Paris
Nouvel Hôpital Civil (NHC) ( Site 1302)
RECRUITING
Strasbourg
Gustave Roussy ( Site 1303)
RECRUITING
Villejuif
India
Artemis hospital ( Site 3307)
RECRUITING
Gurugram
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 3302)
RECRUITING
Mumbai
Tata Memorial Hospital-Medical Oncology ( Site 3304)
RECRUITING
Mumbai
All India Institute of Medical Sciences-Department of medical oncology ( Site 3303)
RECRUITING
New Delhi
Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3301)
RECRUITING
New Delhi
Rajiv Gandhi Cancer Institute And Research Centre ( Site 3300)
ACTIVE_NOT_RECRUITING
New Delhi
Italy
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1802)
RECRUITING
Bari
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1804)
RECRUITING
Florence
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1803)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
RECRUITING
Roma
Japan
National Cancer Center Hospital ( Site 3408)
RECRUITING
Chūō
Kyushu University Hospital ( Site 3400)
RECRUITING
Fukuoka
National Hospital Organization Kyushu Cancer Center ( Site 3401)
RECRUITING
Fukuoka
Kansai Medical University Hospital ( Site 3414)
RECRUITING
Hirakata
Hiroshima City Hiroshima Citizens Hospital ( Site 3419)
RECRUITING
Hiroshima
Kanazawa University Hospital ( Site 3402)
RECRUITING
Kanazawa
St. Marianna University Hospital ( Site 3415)
RECRUITING
Kawasaki
Saitama Prefectural Cancer Center ( Site 3417)
RECRUITING
Kitaadachi-gun
Miyagi Cancer Center ( Site 3406)
RECRUITING
Natori-shi
Niigata Cancer Center Hospital ( Site 3403)
RECRUITING
Niigata
Okayama University Hospital ( Site 3404)
RECRUITING
Okayama
Osaka International Cancer Institute ( Site 3410)
RECRUITING
Osaka
Osaka Metropolitan University Hospital ( Site 3412)
RECRUITING
Osaka
Gunma Prefectural Cancer Center ( Site 3413)
RECRUITING
Ōta
Toho University Omori Medical Center ( Site 3407)
RECRUITING
Ōta-ku
Shizuoka Cancer Center ( Site 3405)
RECRUITING
Sunto-gun
Ehime University Hospital ( Site 3411)
RECRUITING
Tōon
Fujita Health University Hospital ( Site 3409)
RECRUITING
Toyoake
Kanagawa Cancer Center ( Site 3416)
RECRUITING
Yokohama
Malaysia
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 3501)
RECRUITING
George Town
Hospital Tengku Ampuan Afzan ( Site 3506)
RECRUITING
Kuantan
Sarawak General Hospital-Radiotherapy Unit ( Site 3508)
RECRUITING
Kuching
University Malaya Medical Centre ( Site 3507)
RECRUITING
Lembah Pantai
National Cancer Institute-Radiotherapy and Oncology ( Site 3504)
RECRUITING
Putrajaya
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0700)
RECRUITING
Guadalajara
Arké SMO S.A. de C.V. ( Site 0706)
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Servicio de Oncología ( Site 0705)
RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0704)
RECRUITING
Oaxaca City
Oaxaca Site Management Organization S.C. ( Site 0701)
RECRUITING
Oaxaca City
Poland
Bialostockie Centrum Onkologii ( Site 2010)
RECRUITING
Bialystok
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
RECRUITING
Bydgoszcz
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)
RECRUITING
Gliwice
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
RECRUITING
Warsaw
Republic of Korea
Pusan National University Hospital ( Site 3805)
RECRUITING
Busan
Chungbuk National University Hospital ( Site 3804)
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital CRC room 1 ( Site 3814)
RECRUITING
Daegu
National Cancer Center ( Site 3803)
RECRUITING
Goyang-si
Chungnam national university hospital ( Site 3806)
RECRUITING
Junggu
Pusan National University Yangsan Hospital ( Site 3802)
RECRUITING
Pusan
Seoul National University Bundang Hospital ( Site 3807)
RECRUITING
Seongnam
Asan Medical Center ( Site 3810)
RECRUITING
Seoul
Korea University Guro Hospital ( Site 3808)
RECRUITING
Seoul
Samsung Medical Center ( Site 3811)
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3812)
RECRUITING
Seoul
Ajou University Hospital ( Site 3813)
RECRUITING
Suwon
The Catholic University Of Korea St. Vincent's Hospital ( Site 3800)
RECRUITING
Suwon
Spain
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2323)
RECRUITING
Huelva
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2321)
RECRUITING
Lhospitalet De Llobregat
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2322)
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2324)
RECRUITING
Seville
Sweden
Karolinska Universitetssjukhuset Solna ( Site 2401)
RECRUITING
Stockholm
Taiwan
Changhua Christian Hospital ( Site 3904)
RECRUITING
Changhua
National Taiwan University Hospital - Hsinchu branch ( Site 3900)
RECRUITING
Hsinchu
Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital ( Site 3912)
RECRUITING
New Taipei City
Taichung Veterans General Hospital-Chest ( Site 3910)
RECRUITING
Taichung
Chi Mei Hospital - Liouying Branch ( Site 3909)
RECRUITING
Tainan City
National Cheng Kung University Hospital ( Site 3901)
RECRUITING
Tainan City
Mackay Memorial Hospital-Chest Medicine ( Site 3902)
RECRUITING
Taipei
National Taiwan University Hospital-Oncology ( Site 3908)
RECRUITING
Taipei
Taipei Medical University Hospital ( Site 3903)
RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 3907)
RECRUITING
Taipei City
Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 3911)
RECRUITING
Taoyuan District
Thailand
Faculty of Medicine Siriraj Hospital ( Site 4004)
RECRUITING
Bangkok
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 4006)
RECRUITING
Dusit
Songklanagarind hospital ( Site 4003)
RECRUITING
Hat Yai
Lampang Cancer Hospital ( Site 4000)
RECRUITING
Lampang
Faculty of Medicine - Khon Kaen University ( Site 4002)
RECRUITING
Muang
Maharaj Nakorn Chiang Mai Hospital ( Site 4005)
RECRUITING
Muang
Ramathibodi Hospital ( Site 4001)
RECRUITING
Ratchathewi
Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2504)
RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi ( Site 2500)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)
RECRUITING
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)
RECRUITING
Ankara
I.E.U. Medical Point Hastanesi-Oncology ( Site 2503)
RECRUITING
Izmir
Viet Nam
Hanoi Oncology Hospital ( Site 4198)
RECRUITING
Hanoi
K Hospital - National Cancer Hospital ( Site 4193)
RECRUITING
Hanoi
National Lung Hospital-Oncology Department ( Site 4194)
RECRUITING
Hanoi
Cho Ray Hospital ( Site 4190)
RECRUITING
Ho Chi Minh City
Oncology Hospital ( Site 4191)
RECRUITING
Ho Chi Minh City
Tam Anh TP.HCM General Hospital ( Site 4196)
RECRUITING
Ho Chi Minh City
Thong Nhat Hospital ( Site 4192)
RECRUITING
Tan Binh District
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-06-11
Estimated 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