Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)
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
5 other identifiers
interventional
520
19 countries
156
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2024
Longer than P75 for phase_3
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedStudy Start
First participant enrolled
June 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 14, 2030
June 9, 2026
June 1, 2026
4.2 years
March 5, 2024
June 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause. Overall survival for all randomized participants will be reported.
Up to approximately 51 months
Secondary Outcomes (13)
Progression-Free Survival (PFS)
Up to approximately 51 months
Objective Response Rate (ORR)
Up to approximately 51 months
Duration of Response (DOR)
Up to approximately 51 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Baseline and up to approximately 6 years
Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30
Baseline and up to approximately 6 years
- +8 more secondary outcomes
Study Arms (2)
Sacituzumab tirumotecan
EXPERIMENTALParticipants 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.
Pemetrexed Plus Carboplatin
ACTIVE COMPARATORParticipants 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.
Interventions
Administered as rescue medication per approved product label
4 mg/kg via IV infusion
Administered as rescue medication per approved product label
Administered as rescue medication per approved product label
Administered as rescue medication per approved product label
Administered as rescue medication per approved product label
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Predominantly squamous cell histology NSCLC.
- History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- Grade ≥2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
- Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Received radiation therapy to the lung that is \>30 Gray within 6 months of the first dose of study intervention.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Active infection requiring systemic therapy.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Concurrent active HBV and HCV infection.
- History of allogeneic tissue/solid organ transplant.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (156)
Kaiser Permanente - Oakland ( Site 0054)
Oakland, California, 94611, United States
Kaiser Permanente - Roseville ( Site 0055)
Roseville, California, 95661, United States
Kaiser Permanente - San Francisco ( Site 0056)
San Francisco, California, 94115, United States
Kaiser Permanente - Santa Clara ( Site 0057)
Santa Clara, California, 95051, United States
Kaiser Permanente-Kaiser Permanente ( Site 0036)
Vallejo, California, 94589, United States
Kaiser Permanente - Walnut Creek ( Site 0058)
Walnut Creek, California, 94596, United States
Mid Florida Hematology and Oncology Center ( Site 0005)
Orange City, Florida, 32763, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
Marietta, Georgia, 30060, United States
University of Michigan ( Site 0009)
Ann Arbor, Michigan, 48109, United States
Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051)
Springfield, Missouri, 65807, United States
Astera Cancer Care ( Site 0032)
East Brunswick, New Jersey, 08816, United States
Stony Brook University-Cancer Center ( Site 0038)
Stony Brook, New York, 11794, United States
Sanford Fargo Medical Center ( Site 0028)
Fargo, North Dakota, 58122, United States
Sanford Cancer Center ( Site 0024)
Sioux Falls, South Dakota, 57104, United States
John Peter Smith Hospital ( Site 0065)
Fort Worth, Texas, 76104, United States
University of Texas MD Anderson ( Site 0063)
Houston, Texas, 77030, United States
Millennium Research & Clinical Development ( Site 0035)
Houston, Texas, 77090, United States
Clinica Adventista Belgrano-Oncology ( Site 0315)
Caba., Buenos Aires, C1430EGF, Argentina
Instituto Alexander Fleming ( Site 0307)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
Río Cuarto, Córdoba Province, X5800ALB, Argentina
Instituto de Oncología de Rosario ( Site 0301)
Rosario, Santa Fe Province, S2000KZE, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303)
La Rioja, F5300COE, Argentina
Cross Cancer Institute ( Site 0201)
Edmonton, Alberta, T6G 1Z2, Canada
Waterloo Regional Health Network (WRHN) ( Site 0207)
Kitchener, Ontario, N2G 1G3, Canada
Princess Margaret Cancer Centre ( Site 0203)
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Centre ( Site 0204)
Montreal, Quebec, H4A 3J1, Canada
Anhui Provincial Cancer Hospital ( Site 3132)
Hefei, Anhui, 230031, China
Beijing Cancer hospital ( Site 3100)
Beijing, Beijing Municipality, 100142, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3107)
Beijing, Beijing Municipality, 100730, China
Chongqing University Cancer Hospital-Medical Oncology ( Site 3128)
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital ( Site 3124)
Fuzhou, Fujian, 350014, China
The First Affiliated hospital of Xiamen University ( Site 3125)
Xiamen, Fujian, 361003, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3102)
Guangzhou, Guangdong, 510515, China
Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103)
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital ( Site 3109)
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital ( Site 3105)
Zhengzhou, Henan, 450008, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3121)
Wuhan, Hubei, 430000, China
Hubei Cancer Hospital ( Site 3122)
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University-Oncology ( Site 3104)
Changsha, Hunan, 410011, China
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 3117)
Nanjing, Jiangsu, 210031, China
The First Affiliated Hospital of Soochow University-Respiratory Department ( Site 3118)
Suzhou, Jiangsu, 215006, China
The Second Affiliated Hospital of Nanchang University ( Site 3119)
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 3130)
Xi'an, Shaanxi, 710004, China
Jinan Central Hospital ( Site 3113)
Jinan, Shandong, 250013, China
Shandong Cancer Hospital ( Site 3112)
Jinan, Shandong, 250117, China
Zhongshan Hospital of Fudan University ( Site 3133)
Shanghai, Shanghai Municipality, 200032, China
Shanxi Cancer Hospital ( Site 3114)
Taiyuan, Shanxi, 410013, China
West China Hospital, Sichuan University ( Site 3126)
Chengdu, Sichuan, 610041, China
Sichuan Cancer hospital. ( Site 3127)
Chengdu, Sichuan, 610042, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3101)
Hangzhou, Zhejiang, 310006, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 3106)
Hangzhou, Zhejiang, 310016, China
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 3120)
Wenzhou, Zhejiang, 325015, China
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
Bogotá, Bogota D.C., 110131, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0606)
Bogotá, Bogota D.C., 111321, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0601)
Valledupar, Cesar Department, 200002, Colombia
IMAT S.A.S ( Site 0602)
Montería, Departamento de Córdoba, 230002, Colombia
Oncologos del Occidente ( Site 0604)
Pereira, Risaralda Department, 660001, Colombia
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 0605)
Cali, Valle del Cauca Department, 760032, Colombia
Nouvel Hôpital Civil (NHC) ( Site 1302)
Strasbourg, Alsace, 67091, France
Clinique Clairval ( Site 1306)
Marseille, Bouches-du-Rhone, 13009, France
Hopitaux Universitaires Paris Centre-Hopital Cochin-Unité d'Oncologie Thoracique ( Site 1304)
Paris, 75014, France
Gustave Roussy ( Site 1303)
Villejuif, Île-de-France Region, 94805, France
Artemis hospital ( Site 3307)
Gurugram, Haryana, 122001, India
Tata Memorial Hospital-Medical Oncology ( Site 3304)
Mumbai, Maharashtra, 400012, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 3302)
Mumbai, Maharashtra, 400053, India
All India Institute of Medical Sciences-Department of medical oncology ( Site 3303)
New Delhi, National Capital Territory of Delhi, 110029, India
Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3301)
New Delhi, National Capital Territory of Delhi, 110076, India
Rajiv Gandhi Cancer Institute And Research Centre ( Site 3300)
New Delhi, National Capital Territory of Delhi, 110085, India
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1802)
Bari, Apulia, 70124, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
Milan, Lombardy, 20133, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1803)
Milan, Lombardy, 20141, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1804)
Florence, Tuscany, 50134, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
Roma, 00168, Italy
Fujita Health University Hospital ( Site 3409)
Toyoake, Aichi-ken, 470-1192, Japan
Ehime University Hospital ( Site 3411)
Tōon, Ehime, 791-0295, Japan
National Hospital Organization Kyushu Cancer Center ( Site 3401)
Fukuoka, Fukuoka, 811-1395, Japan
Gunma Prefectural Cancer Center ( Site 3413)
Ōta, Gunma, 373-8550, Japan
Kanazawa University Hospital ( Site 3402)
Kanazawa, Ishikawa-ken, 920-8641, Japan
St. Marianna University Hospital ( Site 3415)
Kawasaki, Kanagawa, 216-8511, Japan
Kanagawa Cancer Center ( Site 3416)
Yokohama, Kanagawa, 241-8515, Japan
Miyagi Cancer Center ( Site 3406)
Natori-shi, Miyagi, 981-1293, Japan
Kansai Medical University Hospital ( Site 3414)
Hirakata, Osaka, 573-1191, Japan
Saitama Prefectural Cancer Center ( Site 3417)
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center ( Site 3405)
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital ( Site 3408)
Chūō, Tokyo, 104-0045, Japan
Toho University Omori Medical Center ( Site 3407)
Ōta-ku, Tokyo, 143-8541, Japan
Kyushu University Hospital ( Site 3400)
Fukuoka, 812-8582, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3419)
Hiroshima, 730-8518, Japan
Niigata Cancer Center Hospital ( Site 3403)
Niigata, 951-8566, Japan
Okayama University Hospital ( Site 3404)
Okayama, 700-8558, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3410)
Osaka, 541-8567, Japan
Osaka Metropolitan University Hospital ( Site 3412)
Osaka, 545-0051, Japan
University Malaya Medical Centre ( Site 3507)
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
National Cancer Institute-Radiotherapy and Oncology ( Site 3504)
Putrajaya, Kuala Lumpur, 62250, Malaysia
Hospital Tengku Ampuan Afzan ( Site 3506)
Kuantan, Pahang, 25100, Malaysia
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 3501)
George Town, Pulau Pinang, 10450, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 3508)
Kuching, Sarawak, 93586, Malaysia
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0700)
Guadalajara, Jalisco, 44630, Mexico
Arké SMO S.A. de C.V. ( Site 0706)
Mexico City, Mexico City, 06700, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0705)
Monterrey, Nuevo León, 64460, Mexico
Oaxaca Site Management Organization S.C. ( Site 0701)
Oaxaca City, 68000, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0704)
Oaxaca City, 68020, Mexico
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
Warsaw, Masovian Voivodeship, 02-781, Poland
Bialostockie Centrum Onkologii ( Site 2010)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)
Gliwice, Silesian Voivodeship, 44-102, Poland
National Cancer Center ( Site 3803)
Goyang-si, Kyonggi-do, 10408, South Korea
Seoul National University Bundang Hospital ( Site 3807)
Seongnam, Kyonggi-do, 13620, South Korea
The Catholic University Of Korea St. Vincent's Hospital ( Site 3800)
Suwon, Kyonggi-do, 16247, South Korea
Ajou University Hospital ( Site 3813)
Suwon, Kyonggi-do, 16499, South Korea
Pusan National University Yangsan Hospital ( Site 3802)
Pusan, Kyongsangnam-do, 50612, South Korea
Chungbuk National University Hospital ( Site 3804)
Cheongju-si, North Chungcheong, 28644, South Korea
Pusan National University Hospital ( Site 3805)
Busan, Pusan-Kwangyokshi, 49241, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 3814)
Daegu, Taegu-Kwangyokshi, 42601, South Korea
Chungnam national university hospital ( Site 3806)
Junggu, Taejon-Kwangyokshi, 35015, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3812)
Seoul, 03312, South Korea
Asan Medical Center ( Site 3810)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 3811)
Seoul, 06351, South Korea
Korea University Guro Hospital ( Site 3808)
Seoul, 08308, South Korea
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2321)
LHospitalet de Llobregat, Barcelona, 08908, Spain
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2322)
Santiago de Compostela, La Coruna, 15706, Spain
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2323)
Huelva, 21005, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2324)
Seville, 41009, Spain
Karolinska Universitetssjukhuset Solna ( Site 2401)
Stockholm, Stockholm County, 171 64, Sweden
National Cheng Kung University Hospital ( Site 3901)
Tainan, Tainan, 704, Taiwan
Chi Mei Hospital - Liouying Branch ( Site 3909)
Tainan, Tainan, 73657, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 3907)
Taipei City, Taipei, 106, Taiwan
Changhua Christian Hospital ( Site 3904)
Changhua, 50006, Taiwan
National Taiwan University Hospital - Hsinchu branch ( Site 3900)
Hsinchu, 300, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)
Kaohsiung City, 83301, Taiwan
Far Eastern Memorial Hospital ( Site 3912)
New Taipei City, 220, Taiwan
Taichung Veterans General Hospital-Chest ( Site 3910)
Taichung, 40705, Taiwan
National Taiwan University Hospital-Oncology ( Site 3908)
Taipei, 10002, Taiwan
Mackay Memorial Hospital-Chest Medicine ( Site 3902)
Taipei, 10449, Taiwan
Taipei Medical University Hospital ( Site 3903)
Taipei, 110301, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 3911)
Taoyuan, 333, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 4004)
Bangkoknoi, Bangkok, 10700, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 4006)
Dusit, Bangkok, 10300, Thailand
Faculty of Medicine - Khon Kaen University ( Site 4002)
Muang, Changwat Khon Kaen, 40002, Thailand
Lampang Cancer Hospital ( Site 4000)
Lampang, Changwat Lampang, 52000, Thailand
Ramathibodi Hospital ( Site 4001)
Ratchathewi, Changwat Ratchaburi, 10400, Thailand
Songklanagarind hospital ( Site 4003)
Hat Yai, Changwat Songkhla, 90110, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 4005)
Muang, Chiang Mai, 50200, Thailand
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2504)
Adana, 01140, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)
Ankara, 06520, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 2500)
Ankara, 06800, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 2503)
Izmir, 35575, Turkey (Türkiye)
Hanoi Oncology Hospital ( Site 4198)
Hanoi, Hanoi, 100000, Vietnam
K Hospital - National Cancer Hospital ( Site 4193)
Hanoi, Hanoi, 100000, Vietnam
National Lung Hospital-Oncology Department ( Site 4194)
Hanoi, Hanoi, 100000, Vietnam
Oncology Hospital ( Site 4191)
Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam
Thong Nhat Hospital ( Site 4192)
Tan Binh District, Ho Chi Minh, 700000, Vietnam
Cho Ray Hospital ( Site 4190)
Ho Chi Minh City, 700000, Vietnam
Tam Anh TP.HCM General Hospital ( Site 4196)
Ho Chi Minh City, 700000, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Unblinded Open-label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 12, 2024
Study Start
June 11, 2024
Primary Completion (Estimated)
August 17, 2028
Study Completion (Estimated)
June 14, 2030
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf