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)

Last updated: April 2, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Sacituzumab tirumotecan

Acetaminophen (or equivalent)

H2 Receptor Antagonist

Clinical Study ID

NCT06305754
2870-009
U1111-1288-3804
2023-504910-31
jRCT2071240041
MK-2870-009
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamousnon-small cell lung cancer (NSCLC).

  • Participants who have adverse events (AEs) due to previous anticancer therapies musthave recovered to Grade <1 or baseline.

  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load.

  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable.

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

  • Life expectancy of at least 3 months.

Exclusion

Exclusion Criteria:

  • Predominantly squamous cell histology NSCLC.

  • History of second malignancy, unless potentially curative treatment has beencompleted with no evidence of malignancy for 3 years.

  • Grade >2 peripheral neuropathy.

  • History of documented severe dry eye syndrome, severe Meibomian gland disease and/orblepharitis, or corneal disease that prevents/delays corneal healing.

  • Active inflammatory bowel disease requiring immunosuppressive medication or previoushistory of inflammatory bowel disease.

  • Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.

  • Received prior radiotherapy within 2 weeks of start of study intervention, orradiation-related toxicities, requiring corticosteroids.

  • Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention. Administration of killed vaccines is allowed.

  • Received radiation therapy to the lung that is >30 Gray within 6 months of the firstdose 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 requiredsteroids or has current pneumonitis/interstitial lung disease.

  • HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman'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 ongoingsurgical complications.

Study Design

Total Participants: 520
Treatment Group(s): 10
Primary Treatment: Sacituzumab tirumotecan
Phase: 3
Study Start date:
June 11, 2024
Estimated Completion Date:
June 14, 2030

Study Description

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.

Connect with a study center

  • Clinica Adventista Belgrano-Oncology ( Site 0315)

    Caba., Buenos Aires C1430EGF
    Argentina

    Active - Recruiting

  • Instituto Alexander Fleming ( Site 0307)

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
    Argentina

    Active - Recruiting

  • Hospital Británico de Buenos Aires-Oncology ( Site 0304)

    Ciudad autónoma de Buenos Aires, Caba C1280AEB
    Argentina

    Active - Recruiting

  • Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)

    Río Cuarto, Cordoba X5800ALB
    Argentina

    Active - Recruiting

  • Instituto de Oncología de Rosario ( Site 0301)

    Rosario, Santa Fe S2000KZE
    Argentina

    Active - Recruiting

  • Clinica Adventista Belgrano-Oncology ( Site 0315)

    Caba, 1430
    Argentina

    Site Not Available

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303)

    La Rioja, F5300COE
    Argentina

    Active - Recruiting

  • Cross Cancer Institute ( Site 0201)

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • Grand River Hospital ( Site 0207)

    Kitchener, Ontario N2G 1G3
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre ( Site 0203)

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • McGill University Health Centre ( Site 0204)

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Anhui Provincial Cancer Hospital ( Site 3132)

    Hefei, Anhui 230031
    China

    Active - Recruiting

  • Beijing Cancer hospital ( Site 3100)

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Beijing Peking Union Medical College Hospital-pneumology department ( Site 3107)

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital-Medical Oncology ( Site 3128)

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Fujian Cancer Hospital ( Site 3124)

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • The First Affiliated hospital of Xiamen University ( Site 3125)

    XiaMen, Fujian 361003
    China

    Active - Recruiting

  • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103)

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital ( Site 3109)

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • Henan Cancer Hospital ( Site 3105)

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Hubei Cancer Hospital ( Site 3122)

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 3121)

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University-Oncology ( Site 3104)

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 3117)

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University-Respiratory Department ( Site 3118)

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University ( Site 3119)

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 3130)

    XI An, Shaanxi 710004
    China

    Active - Recruiting

  • Jinan Central Hospital ( Site 3113)

    Jinan, Shandong 250013
    China

    Active - Recruiting

  • Shandong Cancer Hospital ( Site 3112)

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Zhongshan Hospital of Fudan University ( Site 3133)

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanxi Cancer Hospital ( Site 3114)

    Taiyuan, Shanxi 033013
    China

    Active - Recruiting

  • West China Hospital, Sichuan University ( Site 3126)

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

  • Sichuan Cancer hospital ( Site 3127)

    Chengdu, Sichuan 610042
    China

    Active - Recruiting

  • Sichuan Cancer hospital. ( Site 3127)

    Chengdu, Sichuan 610042
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 3106)

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3101)

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 3120)

    Wenzhou, Zhejiang 325015
    China

    Active - Recruiting

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0601)

    Valledupar, Cesar 200001
    Colombia

    Active - Recruiting

  • Oncomedica S.A.S ( Site 0602)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0606)

    Bogota, Distrito Capital De Bogota 111321
    Colombia

    Active - Recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit

    Bogota, Distrito Capital De Bogota 110131
    Colombia

    Active - Recruiting

  • Oncologos del Occidente ( Site 0604)

    Pereira, Risaralda 660001
    Colombia

    Site Not Available

  • Oncologos del Occidente ( Site 0604)

    Pereira., Risaralda 660006
    Colombia

    Active - Recruiting

  • Fundacion Valle del Lili- CIC-Oncology CIC ( Site 0605)

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • Nouvel Hôpital Civil (NHC) ( Site 1302)

    Strasbourg, Alsace 67091
    France

    Active - Recruiting

  • Clinique Clairval ( Site 1306)

    Marseille, Bouches-du-Rhone 13009
    France

    Active - Recruiting

  • Hôpital Privé Clairval-CENTRE DE RADIOTHERAPIE ( Site 1306)

    Marseille, Bouches-du-Rhone 13273
    France

    Active - Recruiting

  • Gustave Roussy ( Site 1303)

    Villejuif, Ile-de-France 94805
    France

    Active - Recruiting

  • Hopitaux Universitaires Paris Centre-Hopital Cochin-Unité d'Oncologie Thoracique ( Site 1304)

    Paris, 75014
    France

    Active - Recruiting

  • Artemis hospital ( Site 3307)

    Gurugram, Haryana 122001
    India

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)

    Milan, Lombardia 20133
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1803)

    Milano, Lombardia 20141
    Italy

    Active - Recruiting

  • Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1802)

    Bari, Puglia 70124
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1804)

    Firenze, Toscana 50134
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (

    Roma, 00168
    Italy

    Active - Recruiting

  • Ehime University Hospital ( Site 3411)

    Toon, Ehime 791-0295
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 3401)

    Fukuoka,, Fukuoka 811-1395
    Japan

    Active - Recruiting

  • Gunma Prefectural Cancer Center ( Site 3413)

    Ota, Gunma 373-8550
    Japan

    Active - Recruiting

  • Kanazawa University Hospital ( Site 3402)

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • St. Marianna University Hospital ( Site 3415)

    Kawasaki, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center ( Site 3416)

    Yokohama, Kanagawa 241-8515
    Japan

    Active - Recruiting

  • Miyagi Cancer Center ( Site 3406)

    Natori, Miyagi 981-1293
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital ( Site 3414)

    Hirakata, Osaka 573-1191
    Japan

    Active - Recruiting

  • Saitama Cancer Center ( Site 3417)

    Kitaadachi-gun, Saitama 362-0806
    Japan

    Active - Recruiting

  • Saitama Prefectural Cancer Center ( Site 3417)

    Kitaadachi-gun, Saitama 362-0806
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center ( Site 3405)

    Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital ( Site 3408)

    Chuo, Tokyo 104-0045
    Japan

    Active - Recruiting

  • Kyushu University Hospital ( Site 3400)

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • Hiroshima City Hiroshima Citizens Hospital ( Site 3419)

    Hiroshima, 730-8518
    Japan

    Active - Recruiting

  • Niigata Cancer Center Hospital ( Site 3403)

    Niigata, 951-8566
    Japan

    Active - Recruiting

  • Okayama University Hospital ( Site 3404)

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital ( Site 3412)

    Osaka, 545-0051
    Japan

    Active - Recruiting

  • Chungbuk National University Hospital ( Site 3804)

    Cheongju-si, Chungbuk 28644
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center ( Site 3803)

    Goyang-si, Kyonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital ( Site 3807)

    Seongnam, Kyonggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital ( Site 3813)

    Suwon, Kyonggi-do 16499
    Korea, Republic of

    Active - Recruiting

  • The Catholic University Of Korea St. Vincent's Hospital ( Site 3800)

    Suwon-si, Kyonggi-do 16247
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital ( Site 3802)

    Busan, Kyongsangnam-do 50612
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital ( Site 3802)

    Pusan, Kyongsangnam-do 50612
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital ( Site 3805)

    Busan, Pusan-Kwangyokshi 49241
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Hospital CRC room 1 ( Site 3814)

    Daegu, Taegu-Kwangyokshi 42601
    Korea, Republic of

    Active - Recruiting

  • Chungnam national university hospital ( Site 3806)

    Jung-gu, Taejon-Kwangyokshi 35015
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center ( Site 3810)

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital ( Site 3808)

    Seoul, 08308
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 3811)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3812)

    Seoul, 03312
    Korea, Republic of

    Active - Recruiting

  • University Malaya Medical Centre ( Site 3507)

    Lembah Pantai, Kuala Lumpur 59100
    Malaysia

    Active - Recruiting

  • National Cancer Institute-Radiotherapy and Oncology ( Site 3504)

    Putrajaya, Kuala Lumpur 62250
    Malaysia

    Active - Recruiting

  • Hospital Tengku Ampuan Afzan ( Site 3506)

    Kuantan, Pahang 25100
    Malaysia

    Active - Recruiting

  • Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 3501)

    George Town, Pulau Pinang 10450
    Malaysia

    Active - Recruiting

  • Sarawak General Hospital-Radiotherapy Unit ( Site 3508)

    Kuching, Sarawak 93586
    Malaysia

    Active - Recruiting

  • Arké SMO S.A. de C.V. ( Site 0706)

    Mexico, Distrito Federal 06700
    Mexico

    Active - Recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0700)

    Guadalajara, Jalisco 44630
    Mexico

    Active - Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0704)

    Oaxaca de Juarez, Oaxaca 68020
    Mexico

    Active - Recruiting

  • Oaxaca Site Management Organization S.C. ( Site 0701)

    Oaxaca, 68000
    Mexico

    Active - Recruiting

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)

    Bydgoszcz, Kujawsko-pomorskie 85-796
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

    Warszawa, Mazowieckie 02-781
    Poland

    Active - Recruiting

  • Bialostockie Centrum Onkologii ( Site 2010)

    Bialystok, Podlaskie 15-027
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002

    Gliwice, Slaskie 44-102
    Poland

    Active - Recruiting

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2321)

    LHospitalet de Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2322)

    Santiago de compostela, La Coruna 15706
    Spain

    Active - Recruiting

  • Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2323)

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2324)

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 2401)

    Stockholm, Stockholms Lan 171 64
    Sweden

    Active - Recruiting

  • Changhua Christian Hospital ( Site 3904)

    Changhua County, Changhua 50006
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)

    Kaohsiung Niao Sung Dist, Kaohsiung 83301
    Taiwan

    Active - Recruiting

  • Chi Mei Hospital - Liouying Branch ( Site 3909)

    Tainan City, Tainan 73657
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 3901)

    Tainan City, Tainan 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 3907)

    Taipei City, Taipei 106
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital - Hsinchu branch ( Site 3900)

    Hsinchu, 300
    Taiwan

    Active - Recruiting

  • Far Eastern Memorial Hospital ( Site 3912)

    New Taipei, 220
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital-Chest ( Site 3910)

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital-Chest Medicine ( Site 3902)

    Taipei, 10449
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital-Oncology ( Site 3908)

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital ( Site 3903)

    Taipei, 110301
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 3911)

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Maharaj Nakorn Chiang Mai Hospital ( Site 4005)

    Muang, Chiang Mai 50200
    Thailand

    Active - Recruiting

  • Faculty of Medicine - Khon Kaen University ( Site 4002)

    Muang, Khon Kaen 40002
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 4004)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital ( Site 4001)

    Ratchathewi, Krung Thep Maha Nakhon 10400
    Thailand

    Active - Recruiting

  • Songklanagarind hospital ( Site 4003)

    HatYai, Songkhla 90110
    Thailand

    Active - Recruiting

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2504)

    Adana, 01140
    Turkey

    Active - Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 2500)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)

    Ankara, 06520
    Turkey

    Active - Recruiting

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 2503)

    Izmir, 35575
    Turkey

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center ( Site 0005)

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • University of Michigan ( Site 0009)

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Astera Cancer Care ( Site 0032)

    East Brunswick, New Jersey 08816
    United States

    Active - Recruiting

  • Stony Brook University-Cancer Center ( Site 0038)

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Sanford Fargo Medical Center ( Site 0028)

    Fargo, North Dakota 58122
    United States

    Active - Recruiting

  • Sanford Cancer Center ( Site 0024)

    Sioux Falls, South Dakota 57104
    United States

    Active - Recruiting

  • Millennium Research & Clinical Development ( Site 0035)

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Hanoi Oncology Hospital ( Site 4198)

    Hanoi, Ha Noi 100000
    Vietnam

    Active - Recruiting

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