← Back to searchRecruitingRecruiting
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)
NCT06305754 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
Participants will be randomized 1:1 into two arms:
* Sacituzumab tirumotecan
* Pemetrexed plus Carboplatin
Participants will receive treatment until any of the criteria for discontinuation of study intervention are met.
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 is 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.
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Study design
Enrollment target: 520 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-06-11
Estimated completion: 2030-06-14
Last updated: 2026-04-02
Interventions
Biological: Sacituzumab tirumotecanDrug: PemetrexedDrug: CarboplatinDrug: H1 Receptor AntagonistDrug: H2 Receptor AntagonistDrug: Acetaminophen (or equivalent)Drug: Dexamethasone (or equivalent)Drug: Steroid Mouthwash (dexamethasone or equivalent)
Primary outcomes
- • Progression-Free Survival (PFS) (Up to approximately 51 months)
- • Overall Survival (OS) (Up to approximately 51 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (156)
Kaiser Permanente - Oakland ( Site 0054)Recruiting
Oakland, California, United States
Kaiser Permanente - Roseville ( Site 0055)Recruiting
Roseville, California, United States
Kaiser Permanente - San Francisco ( Site 0056)Recruiting
San Francisco, California, United States
Kaiser Permanente - Santa Clara ( Site 0057)Recruiting
Santa Clara, California, United States
Kaiser Permanente-Kaiser Permanente ( Site 0036)Recruiting
Vallejo, California, United States
Kaiser Permanente - Walnut Creek ( Site 0058)Recruiting
Walnut Creek, California, United States
Mid Florida Hematology and Oncology Center ( Site 0005)Recruiting
Orange City, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)Completed
Marietta, Georgia, United States
University of Michigan ( Site 0009)Recruiting
Ann Arbor, Michigan, United States
Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051)Recruiting
Springfield, Missouri, United States
Astera Cancer Care ( Site 0032)Recruiting
East Brunswick, New Jersey, United States
Stony Brook University-Cancer Center ( Site 0038)Recruiting
Stony Brook, New York, United States
Sanford Fargo Medical Center ( Site 0028)Recruiting
Fargo, North Dakota, United States
Sanford Cancer Center ( Site 0024)Recruiting
Sioux Falls, South Dakota, United States
John Peter Smith Hospital ( Site 0065)Recruiting
Fort Worth, Texas, United States
University of Texas MD Anderson ( Site 0063)Recruiting
Houston, Texas, United States
Millennium Research & Clinical Development ( Site 0035)Completed
Houston, Texas, United States
Clinica Adventista Belgrano-Oncology ( Site 0315)Recruiting
Caba., Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0307)Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0304)Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)Recruiting
Río Cuarto, Córdoba Province, Argentina
Instituto de Oncología de Rosario ( Site 0301)Recruiting
Rosario, Santa Fe Province, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303)Recruiting
La Rioja, Argentina
Cross Cancer Institute ( Site 0201)Recruiting
Edmonton, Alberta, Canada
Waterloo Regional Health Network (WRHN) ( Site 0207)Recruiting
Kitchener, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0203)Recruiting
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0204)Recruiting
Montreal, Quebec, Canada
Anhui Provincial Cancer Hospital ( Site 3132)Active Not Recruiting
Hefei, Anhui, China
Beijing Cancer hospital ( Site 3100)Active Not Recruiting
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3107)Active Not Recruiting
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital-Medical Oncology ( Site 3128)Active Not Recruiting
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital ( Site 3124)Active Not Recruiting
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 3125)Active Not Recruiting
Xiamen, Fujian, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3102)Active Not Recruiting
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103)Active Not Recruiting
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital ( Site 3109)Active Not Recruiting
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 3105)Completed
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3121)Active Not Recruiting
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 3122)Active Not Recruiting
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University-Oncology ( Site 3104)Active Not Recruiting
Changsha, Hunan, China
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 3117)Active Not Recruiting
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University-Respiratory Department ( Site 3118)Completed
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University ( Site 3119)Completed
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 3130)Active Not Recruiting
Xi'an, Shaanxi, China
Jinan Central Hospital ( Site 3113)Active Not Recruiting
Jinan, Shandong, China
Shandong Cancer Hospital ( Site 3112)Active Not Recruiting
Jinan, Shandong, China
Zhongshan Hospital of Fudan University ( Site 3133)Active Not Recruiting
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital ( Site 3114)Active Not Recruiting
Taiyuan, Shanxi, China
West China Hospital, Sichuan University ( Site 3126)Active Not Recruiting
Chengdu, Sichuan, China
Sichuan Cancer hospital. ( Site 3127)Active Not Recruiting
Chengdu, Sichuan, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3101)Completed
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 3106)Active Not Recruiting
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 3120)Active Not Recruiting
Wenzhou, Zhejiang, China
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)Recruiting
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0606)Recruiting
Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0601)Recruiting
Valledupar, Cesar Department, Colombia
IMAT S.A.S ( Site 0602)Recruiting
Montería, Departamento de Córdoba, Colombia
Oncologos del Occidente ( Site 0604)Recruiting
Pereira, Risaralda Department, Colombia
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 0605)Recruiting
Cali, Valle del Cauca Department, Colombia
Nouvel Hôpital Civil (NHC) ( Site 1302)Recruiting
Strasbourg, Alsace, France
Clinique Clairval ( Site 1306)Recruiting
Marseille, Bouches-du-Rhone, France
Hopitaux Universitaires Paris Centre-Hopital Cochin-Unité d'Oncologie Thoracique ( Site 1304)Recruiting
Paris, France
Gustave Roussy ( Site 1303)Recruiting
Villejuif, Île-de-France Region, France
Artemis hospital ( Site 3307)Recruiting
Gurugram, Haryana, India
Tata Memorial Hospital-Medical Oncology ( Site 3304)Recruiting
Mumbai, Maharashtra, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 3302)Completed
Mumbai, Maharashtra, India
All India Institute of Medical Sciences-Department of medical oncology ( Site 3303)Recruiting
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospitals-APOLLO RESEARCH INNOVATION ( Site 3301)Active Not Recruiting
New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre ( Site 3300)Active Not Recruiting
New Delhi, National Capital Territory of Delhi, India
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1802)Recruiting
Bari, Apulia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)Recruiting
Milan, Lombardy, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1803)Recruiting
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1804)Recruiting
Florence, Tuscany, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)Recruiting
Roma, Italy
Fujita Health University Hospital ( Site 3409)Recruiting
Toyoake, Aichi-ken, Japan
Ehime University Hospital ( Site 3411)Recruiting
Tōon, Ehime, Japan
National Hospital Organization Kyushu Cancer Center ( Site 3401)Recruiting
Fukuoka, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 3413)Recruiting
Ōta, Gunma, Japan
Kanazawa University Hospital ( Site 3402)Recruiting
Kanazawa, Ishikawa-ken, Japan
St. Marianna University Hospital ( Site 3415)Recruiting
Kawasaki, Kanagawa, Japan
Kanagawa Cancer Center ( Site 3416)Recruiting
Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 3406)Recruiting
Natori-shi, Miyagi, Japan
Kansai Medical University Hospital ( Site 3414)Recruiting
Hirakata, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 3417)Recruiting
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center ( Site 3405)Recruiting
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 3408)Recruiting
Chūō, Tokyo, Japan
Toho University Omori Medical Center ( Site 3407)Recruiting
Ōta-ku, Tokyo, Japan
Kyushu University Hospital ( Site 3400)Recruiting
Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3419)Recruiting
Hiroshima, Japan
Niigata Cancer Center Hospital ( Site 3403)Recruiting
Niigata, Japan
Okayama University Hospital ( Site 3404)Recruiting
Okayama, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3410)Recruiting
Osaka, Japan
Osaka Metropolitan University Hospital ( Site 3412)Recruiting
Osaka, Japan
University Malaya Medical Centre ( Site 3507)Recruiting
Lembah Pantai, Kuala Lumpur, Malaysia
National Cancer Institute-Radiotherapy and Oncology ( Site 3504)Recruiting
Putrajaya, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan ( Site 3506)Recruiting
Kuantan, Pahang, Malaysia
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 3501)Recruiting
George Town, Pulau Pinang, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 3508)Recruiting
Kuching, Sarawak, Malaysia
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0700)Recruiting
Guadalajara, Jalisco, Mexico
Arké SMO S.A. de C.V. ( Site 0706)Recruiting
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0705)Recruiting
Monterrey, Nuevo León, Mexico
Oaxaca Site Management Organization S.C. ( Site 0701)Recruiting
Oaxaca City, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0704)Recruiting
Oaxaca City, Mexico
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)Recruiting
Warsaw, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 2010)Completed
Bialystok, Podlaskie Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)Recruiting
Gliwice, Silesian Voivodeship, Poland
National Cancer Center ( Site 3803)Recruiting
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 3807)Active Not Recruiting
Seongnam, Kyonggi-do, South Korea
The Catholic University Of Korea St. Vincent's Hospital ( Site 3800)Active Not Recruiting
Suwon, Kyonggi-do, South Korea
Ajou University Hospital ( Site 3813)Recruiting
Suwon, Kyonggi-do, South Korea
Pusan National University Yangsan Hospital ( Site 3802)Active Not Recruiting
Pusan, Kyongsangnam-do, South Korea
Chungbuk National University Hospital ( Site 3804)Active Not Recruiting
Cheongju-si, North Chungcheong, South Korea
Pusan National University Hospital ( Site 3805)Active Not Recruiting
Busan, Pusan-Kwangyokshi, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 3814)Completed
Daegu, Taegu-Kwangyokshi, South Korea
Chungnam national university hospital ( Site 3806)Active Not Recruiting
Junggu, Taejon-Kwangyokshi, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3812)Completed
Seoul, South Korea
Asan Medical Center ( Site 3810)Active Not Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 3811)Active Not Recruiting
Seoul, South Korea
Korea University Guro Hospital ( Site 3808)Active Not Recruiting
Seoul, South Korea
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2321)Recruiting
LHospitalet de Llobregat, Barcelona, Spain
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2322)Recruiting
Santiago de Compostela, La Coruna, Spain
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2323)Recruiting
Huelva, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2324)Recruiting
Seville, Spain
Karolinska Universitetssjukhuset Solna ( Site 2401)Recruiting
Stockholm, Stockholm County, Sweden
National Cheng Kung University Hospital ( Site 3901)Recruiting
Tainan, Tainan, Taiwan
Chi Mei Hospital - Liouying Branch ( Site 3909)Recruiting
Tainan, Tainan, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 3907)Recruiting
Taipei City, Taipei, Taiwan
Changhua Christian Hospital ( Site 3904)Recruiting
Changhua, Taiwan
National Taiwan University Hospital - Hsinchu branch ( Site 3900)Recruiting
Hsinchu, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)Recruiting
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital ( Site 3912)Recruiting
New Taipei City, Taiwan
Taichung Veterans General Hospital-Chest ( Site 3910)Recruiting
Taichung, Taiwan
National Taiwan University Hospital-Oncology ( Site 3908)Recruiting
Taipei, Taiwan
Mackay Memorial Hospital-Chest Medicine ( Site 3902)Recruiting
Taipei, Taiwan
Taipei Medical University Hospital ( Site 3903)Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 3911)Recruiting
Taoyuan District, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 4004)Active Not Recruiting
Bangkoknoi, Bangkok, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 4006)Active Not Recruiting
Dusit, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 4002)Active Not Recruiting
Muang, Changwat Khon Kaen, Thailand
Lampang Cancer Hospital ( Site 4000)Active Not Recruiting
Lampang, Changwat Lampang, Thailand
Ramathibodi Hospital ( Site 4001)Active Not Recruiting
Ratchathewi, Changwat Ratchaburi, Thailand
Songklanagarind hospital ( Site 4003)Active Not Recruiting
Hat Yai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 4005)Active Not Recruiting
Muang, Chiang Mai, Thailand
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2504)Recruiting
Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)Recruiting
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 2500)Recruiting
Ankara, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 2503)Recruiting
Izmir, Turkey (Türkiye)
Hanoi Oncology Hospital ( Site 4198)Active Not Recruiting
Hanoi, Hanoi, Vietnam
K Hospital - National Cancer Hospital ( Site 4193)Active Not Recruiting
Hanoi, Hanoi, Vietnam
National Lung Hospital-Oncology Department ( Site 4194)Active Not Recruiting
Hanoi, Hanoi, Vietnam
Oncology Hospital ( Site 4191)Active Not Recruiting
Ho Chi Minh City, Ho Chi Minh, Vietnam
Thong Nhat Hospital ( Site 4192)Active Not Recruiting
Tan Binh District, Ho Chi Minh, Vietnam
Cho Ray Hospital ( Site 4190)Active Not Recruiting
Ho Chi Minh City, Vietnam
Tam Anh TP.HCM General Hospital ( Site 4196)Active Not Recruiting
Ho Chi Minh City, Vietnam