A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations

Status: Recruiting
Location: See all (185) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.

• Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.

• Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.

• Measurable disease per RECIST 1.1 as assessed by the local site investigator.

• Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided

• Participants who have 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 HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.

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

• Have an ECOG performance status of 0 or 1 within 3 days before randomization.

Locations
United States
California
UCLA Hematology/Oncology - Santa Monica ( Site 0023)
RECRUITING
Los Angeles
Florida
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)
RECRUITING
Jacksonville
Mid Florida Hematology and Oncology Center ( Site 0005)
COMPLETED
Orange City
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
RECRUITING
Marietta
Michigan
Karmanos Cancer Institute ( Site 0018)
RECRUITING
Detroit
Minnesota
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)
RECRUITING
Rochester
Mississippi
Hattiesburg Clinic Hematology/Oncology ( Site 0010)
RECRUITING
Hattiesburg
Nebraska
University Of Nebraska Medical Center ( Site 0011)
RECRUITING
Omaha
New Jersey
Englewood Hospital and Medical Center ( Site 0033)
RECRUITING
Englewood
Atlantic Health System Morristown Medical Center ( Site 0031)
RECRUITING
Morristown
Capital Health Medical Center - Hopewell ( Site 0006)
COMPLETED
Pennington
Ohio
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)
RECRUITING
Cincinnati
Virginia
VCU Health Adult Outpatient Pavillion ( Site 0026)
RECRUITING
Richmond
Other Locations
Australia
Monash Health-Oncology Research ( Site 3001)
RECRUITING
Clayton
St. George Private Hospital ( Site 3004)
RECRUITING
Kogarah
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003)
RECRUITING
Melbourne
Westmead Hospital ( Site 3000)
RECRUITING
Westmead
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444)
ACTIVE_NOT_RECRUITING
Barretos
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447)
ACTIVE_NOT_RECRUITING
Natal
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440)
ACTIVE_NOT_RECRUITING
Porto Alegre
A. C. Camargo Cancer Center-CAPEC ( Site 0442)
ACTIVE_NOT_RECRUITING
São Paulo
Hospital Paulistano-Americas Oncologia ( Site 0441)
ACTIVE_NOT_RECRUITING
São Paulo
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446)
ACTIVE_NOT_RECRUITING
São Paulo
Canada
William Osler Health System ( Site 0205)
ACTIVE_NOT_RECRUITING
Brampton
Princess Margaret Cancer Centre ( Site 0204)
ACTIVE_NOT_RECRUITING
Toronto
Chile
Bradfordhill-Clinical Area ( Site 0507)
ACTIVE_NOT_RECRUITING
Santiago
Centro de Estudios Clínicos SAGA ( Site 0517)
ACTIVE_NOT_RECRUITING
Santiago
Clínica RedSalud Vitacura ( Site 0511)
ACTIVE_NOT_RECRUITING
Santiago
FALP-UIDO ( Site 0509)
ACTIVE_NOT_RECRUITING
Santiago
K2 Oncology ( Site 0514)
ACTIVE_NOT_RECRUITING
Santiago
Orlandi Oncologia-Oncology ( Site 0504)
ACTIVE_NOT_RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 0502)
ACTIVE_NOT_RECRUITING
Santiago
Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
ACTIVE_NOT_RECRUITING
Talca
Centro Investigacion Cancer James Lind ( Site 0513)
ACTIVE_NOT_RECRUITING
Temuco
ONCOCENTRO APYS-ACEREY ( Site 0500)
ACTIVE_NOT_RECRUITING
Viña Del Mar
China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810)
ACTIVE_NOT_RECRUITING
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815)
ACTIVE_NOT_RECRUITING
Beijing
Jilin Province Tumor Hospital-clinical research ( Site 2803)
ACTIVE_NOT_RECRUITING
Changchun
Hunan Cancer Hospital-thoracic oncology II ( Site 2808)
ACTIVE_NOT_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University ( Site 2827)
ACTIVE_NOT_RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 2822)
ACTIVE_NOT_RECRUITING
Chengdu
West China Hospital, Sichuan University-Lung cancer center ( Site 2826)
ACTIVE_NOT_RECRUITING
Chengdu
Chongqing University Cancer Hospital-Medical Oncology ( Site 2814)
ACTIVE_NOT_RECRUITING
Chongqing
Fujian Cancer Hospital ( Site 2819)
ACTIVE_NOT_RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818)
ACTIVE_NOT_RECRUITING
Guangzhou
Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828)
ACTIVE_NOT_RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 2829)
ACTIVE_NOT_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital-oncology of department ( Site 2807)
ACTIVE_NOT_RECRUITING
Harbin
Anhui Provincial Cancer Hospital ( Site 2830)
COMPLETED
Hefei
Jinan Central Hospital-oncology department ( Site 2802)
COMPLETED
Jinan
Yunnan Province Cancer Hospital ( Site 2824)
ACTIVE_NOT_RECRUITING
Kunming
LinYi Cancer Hospital ( Site 2804)
ACTIVE_NOT_RECRUITING
Linyi
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821)
ACTIVE_NOT_RECRUITING
Nanchang
Nanjing Drum Tower Hospital ( Site 2812)
ACTIVE_NOT_RECRUITING
Nangjing
Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816)
ACTIVE_NOT_RECRUITING
Nanning
Fudan University Shanghai Cancer Center-Oncology ( Site 2811)
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Chest Hospital-Oncology department ( Site 2800)
ACTIVE_NOT_RECRUITING
Shanghai
Hubei Cancer Hospital ( Site 2809)
ACTIVE_NOT_RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 2805)
ACTIVE_NOT_RECRUITING
Wuhan
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806)
ACTIVE_NOT_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817)
COMPLETED
Xi'an
The First Affiliated hospital of Xiamen University ( Site 2820)
ACTIVE_NOT_RECRUITING
Xiamen
Henan Cancer Hospital-henan cancer hospital ( Site 2813)
COMPLETED
Zhengzhou
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303)
ACTIVE_NOT_RECRUITING
Bordeaux
CENTRE LEON BERARD ( Site 1305)
ACTIVE_NOT_RECRUITING
Lyon Cedex08
Groupe hospitalier Paris saint Joseph. ( Site 1307)
ACTIVE_NOT_RECRUITING
Paris
Institut Curie-Thorax Institute ( Site 1304)
ACTIVE_NOT_RECRUITING
Paris
CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300)
ACTIVE_NOT_RECRUITING
Rouen
Germany
Klinikum Chemnitz - Flemmingstraße ( Site 1401)
ACTIVE_NOT_RECRUITING
Chemnitz
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402)
ACTIVE_NOT_RECRUITING
Dresden
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400)
ACTIVE_NOT_RECRUITING
Essen
Universitaetsklinikum Freiburg ( Site 1405)
ACTIVE_NOT_RECRUITING
Freiburg
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407)
ACTIVE_NOT_RECRUITING
Göttingen
Asklepios Klinik Harburg ( Site 1403)
ACTIVE_NOT_RECRUITING
Hamburg
Greece
Aretaieio Hospital ( Site 2702)
ACTIVE_NOT_RECRUITING
Athens
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705)
ACTIVE_NOT_RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700)
ACTIVE_NOT_RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704)
ACTIVE_NOT_RECRUITING
Chaidari, Athens
Papageorgiou General Hospital of Thessaloniki ( Site 2701)
ACTIVE_NOT_RECRUITING
Thessaloniki
Theagenio Cancer Hospital of Thessaloniki ( Site 2703)
ACTIVE_NOT_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Hong Kong Integrated Oncology Centre ( Site 3200)
RECRUITING
Central
Queen Mary Hospital ( Site 3203)
RECRUITING
Hksar
Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204)
RECRUITING
Kowloon
Princess Margaret Hospital-Department of Oncology ( Site 3201)
RECRUITING
Lai Chi Kok
Israel
Rambam Health Care Campus-Oncology Division ( Site 1702)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 1700)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1703)
RECRUITING
Petah Tikva
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 1806)
ACTIVE_NOT_RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
ACTIVE_NOT_RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
ACTIVE_NOT_RECRUITING
Rome
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805)
ACTIVE_NOT_RECRUITING
Rome
Istituto Clinico Humanitas ( Site 1803)
ACTIVE_NOT_RECRUITING
Rozzano
Japan
Chiba University Hospital ( Site 3411)
ACTIVE_NOT_RECRUITING
Chiba
Kyushu University Hospital ( Site 3407)
ACTIVE_NOT_RECRUITING
Fukuoka
National Hospital Organization Kyushu Medical Center ( Site 3412)
ACTIVE_NOT_RECRUITING
Fukuoka
Kansai Medical University Hospital ( Site 3410)
RECRUITING
Hirakata
Kanazawa University Hospital ( Site 3414)
ACTIVE_NOT_RECRUITING
Kanazawa
National Cancer Center Hospital East ( Site 3406)
RECRUITING
Kashiwa
Cancer Institute Hospital of JFCR ( Site 3402)
ACTIVE_NOT_RECRUITING
Koto
National Hospital Organization Shikoku Cancer Center ( Site 3415)
ACTIVE_NOT_RECRUITING
Matsuyama
Shizuoka Cancer Center ( Site 3403)
ACTIVE_NOT_RECRUITING
Nagaizumi-cho,sunto-gun
Aichi Cancer Center ( Site 3400)
RECRUITING
Nagoya
Miyagi Cancer Center ( Site 3416)
RECRUITING
Natori-shi
Niigata Cancer Center Hospital ( Site 3405)
ACTIVE_NOT_RECRUITING
Niigata
Okayama University Hospital ( Site 3417)
ACTIVE_NOT_RECRUITING
Okayama
Osaka International Cancer Institute ( Site 3413)
ACTIVE_NOT_RECRUITING
Osaka
Gunma Prefectural Cancer Center ( Site 3418)
ACTIVE_NOT_RECRUITING
Otashi
Sendai Kousei Hospital ( Site 3401)
RECRUITING
Sendai
Takarazuka City Hospital ( Site 3409)
ACTIVE_NOT_RECRUITING
Takarazuka
Nippon Medical School Hospital ( Site 3408)
RECRUITING
Tokyo
Fujita Health University Hospital ( Site 3419)
ACTIVE_NOT_RECRUITING
Toyoake
Kanagawa Cancer Center ( Site 3404)
ACTIVE_NOT_RECRUITING
Yokohama
Malaysia
Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502)
ACTIVE_NOT_RECRUITING
Kota Bharu
Sarawak General Hospital-Radiotherapy Unit ( Site 3500)
ACTIVE_NOT_RECRUITING
Kuching
National Cancer Institute-Radiotherapy and Oncology ( Site 3504)
ACTIVE_NOT_RECRUITING
Putrajaya
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706)
RECRUITING
Guadalajara
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Hematologia and Oncologia ( Site 0704)
ACTIVE_NOT_RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0701)
ACTIVE_NOT_RECRUITING
Oaxaca City
Clinica Integral Internacional de Oncología ( Site 0705)
ACTIVE_NOT_RECRUITING
Puebla City
Philippines
THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600)
RECRUITING
Iloilo City
Manila Doctors Hospital-Clinical Trial Office ( Site 3604)
ACTIVE_NOT_RECRUITING
Manila
Asian Hospital and Medical Center ( Site 3605)
ACTIVE_NOT_RECRUITING
Muntinlupa
THE MEDICAL CITY-Cancer Research Center ( Site 3603)
ACTIVE_NOT_RECRUITING
Pasig
ST. LUKE'S MEDICAL CENTER ( Site 3601)
ACTIVE_NOT_RECRUITING
Quezon City
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602)
RECRUITING
San Juan City, Metro Manila
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
ACTIVE_NOT_RECRUITING
Bydgoszcz
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)
ACTIVE_NOT_RECRUITING
Gliwice
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005)
ACTIVE_NOT_RECRUITING
Kielce
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
ACTIVE_NOT_RECRUITING
Przemyśl
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009)
COMPLETED
Torun
Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011)
ACTIVE_NOT_RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
ACTIVE_NOT_RECRUITING
Warsaw
Republic of Korea
Pusan National University Hospital ( Site 3805)
RECRUITING
Busan
Chungbuk National University Hospital-Internal medicine ( Site 3809)
ACTIVE_NOT_RECRUITING
Cheongju-si
National Cancer Center-Lung Cancer Center ( Site 3810)
RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807)
RECRUITING
Hwasun
Chungnam national university hospital ( Site 3808)
RECRUITING
Junggu
Seoul National University Bundang Hospital ( Site 3806)
RECRUITING
Seongnam
Asan Medical Center ( Site 3801)
RECRUITING
Seoul
Kangbuk Samsung Hospital ( Site 3813)
ACTIVE_NOT_RECRUITING
Seoul
Konkuk University Medical Center ( Site 3812)
ACTIVE_NOT_RECRUITING
Seoul
Korea University Guro Hospital-Internal Medicine ( Site 3800)
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804)
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803)
ACTIVE_NOT_RECRUITING
Suwon
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811)
RECRUITING
Yangsan
Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Insular de Gran Canaria-Oncology ( Site 2305)
ACTIVE_NOT_RECRUITING
Las Palmas De Gran Canaria
Clinica Universidad de Navarra-Medical Oncology ( Site 2306)
ACTIVE_NOT_RECRUITING
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303)
ACTIVE_NOT_RECRUITING
Madrid
H.R.U Málaga - Hospital General-Oncology ( Site 2302)
ACTIVE_NOT_RECRUITING
Málaga
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301)
ACTIVE_NOT_RECRUITING
Pozuelo De Alarcón
Taiwan
Changhua Christian Hospital ( Site 3908)
ACTIVE_NOT_RECRUITING
Changhua
National Taiwan University Hospital - Hsinchu branch ( Site 3907)
ACTIVE_NOT_RECRUITING
Hsinchu
Chang Gung Memorial Hospital at Kaohsiung ( Site 3906)
ACTIVE_NOT_RECRUITING
Kaohsiung City
E-Da hospital ( Site 3911)
ACTIVE_NOT_RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912)
ACTIVE_NOT_RECRUITING
Kaohsiung City
Chi Mei Medical Center ( Site 3910)
ACTIVE_NOT_RECRUITING
Tainan City
National Cheng Kung University Hospital ( Site 3909)
ACTIVE_NOT_RECRUITING
Tainan City
Mackay Memorial Hospital-Chest Medicine ( Site 3902)
ACTIVE_NOT_RECRUITING
Taipei
National Taiwan University Hospital-Oncology ( Site 3904)
ACTIVE_NOT_RECRUITING
Taipei
Taipei Medical University Hospital ( Site 3900)
ACTIVE_NOT_RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 3903)
ACTIVE_NOT_RECRUITING
Taipei City
Thailand
Faculty of Medicine Siriraj Hospital ( Site 4000)
RECRUITING
Bangkok
Songklanagarind hospital ( Site 4001)
ACTIVE_NOT_RECRUITING
Hat Yai
Faculty of Medicine - Khon Kaen University ( Site 4004)
RECRUITING
Khon Kaen
Lampang Cancer Hospital ( Site 4005)
ACTIVE_NOT_RECRUITING
Muang
Maharaj Nakorn Chiang Mai Hospital ( Site 4003)
ACTIVE_NOT_RECRUITING
Muang
Sunpasitthiprasong Hospital-Oncology ( Site 4002)
ACTIVE_NOT_RECRUITING
Ubon Ratchathani
Turkey
Adana Medical Park Seyhan Hastanesi ( Site 2506)
ACTIVE_NOT_RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501)
ACTIVE_NOT_RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
ACTIVE_NOT_RECRUITING
Ankara
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504)
ACTIVE_NOT_RECRUITING
Bornova
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
ACTIVE_NOT_RECRUITING
Istanbul
Medipol Mega Universite Hastanesi-oncology ( Site 2505)
ACTIVE_NOT_RECRUITING
Stanbul
United Kingdom
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603)
ACTIVE_NOT_RECRUITING
London
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606)
ACTIVE_NOT_RECRUITING
London
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600)
ACTIVE_NOT_RECRUITING
London
The Christie NHS Foundation Trust ( Site 2604)
ACTIVE_NOT_RECRUITING
Manchester
The Clatterbridge Cancer Centre ( Site 2602)
ACTIVE_NOT_RECRUITING
Metropolitan Borough Of Wirral
Royal Marsden Hospital (Sutton) ( Site 2605)
RECRUITING
Sutton
Viet Nam
Hanoi Oncology Hospital ( Site 4102)
ACTIVE_NOT_RECRUITING
Hanoi
K Hospital - National Cancer Hospital ( Site 4105)
ACTIVE_NOT_RECRUITING
Hanoi
National Lung Hospital-Oncology Department ( Site 4104)
ACTIVE_NOT_RECRUITING
Hanoi
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-11-12
Estimated Completion Date: 2030-03-11
Participants
Target number of participants: 556
Treatments
Experimental: Sacituzumab tirumotecan
Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Active_comparator: Chemotherapy
Participants will receive 75 mg/m\^2 of docetaxel or 500 mg/m\^2 of pemetrexed by IV infusion on Days 1 and 22 of every 6-week cycle.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov