Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

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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: Active_not_recruiting
Location: See all (189) 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 hypothesis is that sacituzumab tirumotecan is 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)
Los Angeles
Florida
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)
Jacksonville
Mid Florida Hematology and Oncology Center ( Site 0005)
Orange City
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
Marietta
Michigan
Karmanos Cancer Institute ( Site 0018)
Detroit
Minnesota
Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)
Rochester
Mississippi
Hattiesburg Clinic Hematology/Oncology ( Site 0010)
Hattiesburg
Nebraska
University Of Nebraska Medical Center ( Site 0011)
Omaha
New Jersey
Englewood Hospital and Medical Center ( Site 0033)
Englewood
Atlantic Health System Morristown Medical Center ( Site 0031)
Morristown
Capital Health Medical Center - Hopewell ( Site 0006)
Pennington
Ohio
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)
Cincinnati
Tennessee
Tennessee Oncology (0036)
Nashville
Texas
University of Texas MD Anderson (0037)
Houston
Virginia
VCU Health Adult Outpatient Pavillion ( Site 0026)
Richmond
Other Locations
Australia
Monash Health-Oncology Research ( Site 3001)
Clayton
St. George Private Hospital ( Site 3004)
Kogarah
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003)
Melbourne
Westmead Hospital ( Site 3000)
Westmead
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444)
Barretos
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447)
Natal
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440)
Porto Alegre
A. C. Camargo Cancer Center-CAPEC ( Site 0442)
São Paulo
Hospital Paulistano-Americas Oncologia ( Site 0441)
São Paulo
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica (Site 0448)
São Paulo
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446)
São Paulo
Hospital Santa Rita de Cassia (Site 0449)
Vitória
Canada
William Osler Health System ( Site 0205)
Brampton
Princess Margaret Cancer Centre ( Site 0204)
Toronto
Chile
Bradfordhill-Clinical Area (Site 0507)
Santiago
Centro de Estudios Clínicos SAGA (Site 0517)
Santiago
Clínica RedSalud Vitacura (Site 0511)
Santiago
FALP-UIDO (Site 0509)
Santiago
K2 Oncology (Site 0514)
Santiago
Orlandi Oncologia-Oncology ( Site 0504)
Santiago
Pontificia Universidad Catolica de Chile ( Site 0502)
Santiago
Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
Talca
Centro Investigacion Cancer James Lind ( Site 0513)
Temuco
ONCOCENTRO APYS-ACEREY (Site 0500)
Viña Del Mar
China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810)
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815)
Beijing
Jilin Province Tumor Hospital-clinical research ( Site 2803)
Changchun
Hunan Cancer Hospital-thoracic oncology II ( Site 2808)
Changsha
The Second Xiangya Hospital of Central South University ( Site 2827)
Changsha
Sichuan Cancer hospital. ( Site 2822)
Chengdu
West China Hospital, Sichuan University-Lung cancer center ( Site 2826)
Chengdu
Chongqing University Cancer Hospital-Medical Oncology ( Site 2814)
Chongqing
Fujian Cancer Hospital ( Site 2819)
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818)
Guangzhou
Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828)
Hangzhou
Zhejiang Cancer Hospital ( Site 2829)
Hangzhou
Harbin Medical University Cancer Hospital-oncology of department ( Site 2807)
Harbin
Anhui Provincial Cancer Hospital ( Site 2830)
Hefei
Jinan Central Hospital-oncology department ( Site 2802)
Jinan
Yunnan Province Cancer Hospital ( Site 2824)
Kunming
LinYi Cancer Hospital ( Site 2804)
Linyi
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821)
Nanchang
Nanjing Drum Tower Hospital ( Site 2812)
Nangjing
Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816)
Nanning
Fudan University Shanghai Cancer Center-Oncology ( Site 2811)
Shanghai
Shanghai Chest Hospital-Oncology department ( Site 2800)
Shanghai
Hubei Cancer Hospital ( Site 2809)
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 2805)
Wuhan
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806)
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817)
Xi'an
The First Affiliated hospital of Xiamen University ( Site 2820)
Xiamen
Henan Cancer Hospital-henan cancer hospital ( Site 2813)
Zhengzhou
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303)
Bordeaux
CENTRE LEON BERARD ( Site 1305)
Lyon Cedex08
Groupe hospitalier Paris saint Joseph. ( Site 1307)
Paris
Institut Curie-Thorax Institute ( Site 1304)
Paris
CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300)
Rouen
Germany
Klinikum Chemnitz - Flemmingstraße ( Site 1401)
Chemnitz
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402)
Dresden
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400)
Essen
Universitaetsklinikum Freiburg ( Site 1405)
Freiburg
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407)
Göttingen
Asklepios Klinik Harburg ( Site 1403)
Hamburg
Greece
Aretaieio Hospital ( Site 2702)
Athens
Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705)
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700)
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704)
Chaidari, Athens
Papageorgiou General Hospital of Thessaloniki ( Site 2701)
Thessaloniki
Theagenio Cancer Hospital of Thessaloniki ( Site 2703)
Thessaloniki
Hong Kong Special Administrative Region
Hong Kong Integrated Oncology Centre ( Site 3200)
Central
Queen Mary Hospital ( Site 3203)
Hksar
Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204)
Kowloon
Princess Margaret Hospital-Department of Oncology ( Site 3201)
Lai Chi Kok
Israel
Rambam Health Care Campus-Oncology Division ( Site 1702)
Haifa
Shaare Zedek Medical Center ( Site 1700)
Jerusalem
Rabin Medical Center ( Site 1703)
Petah Tikva
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 1806)
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
Rome
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805)
Rome
Istituto Clinico Humanitas ( Site 1803)
Rozzano
Japan
Chiba University Hospital ( Site 3411)
Chiba
Kyushu University Hospital ( Site 3407)
Fukuoka
National Hospital Organization Kyushu Medical Center ( Site 3412)
Fukuoka
Kansai Medical University Hospital ( Site 3410)
Hirakata
Kanazawa University Hospital ( Site 3414)
Kanazawa
National Cancer Center Hospital East ( Site 3406)
Kashiwa
Cancer Institute Hospital of JFCR ( Site 3402)
Koto
National Hospital Organization Shikoku Cancer Center ( Site 3415)
Matsuyama
Shizuoka Cancer Center ( Site 3403)
Nagaizumi-cho,sunto-gun
Aichi Cancer Center ( Site 3400)
Nagoya
Miyagi Cancer Center ( Site 3416)
Natori-shi
Niigata Cancer Center Hospital ( Site 3405)
Niigata
Okayama University Hospital ( Site 3417)
Okayama
Osaka International Cancer Institute ( Site 3413)
Osaka
Gunma Prefectural Cancer Center ( Site 3418)
Otashi
Sendai Kousei Hospital ( Site 3401)
Sendai
Takarazuka City Hospital ( Site 3409)
Takarazuka
Nippon Medical School Hospital ( Site 3408)
Tokyo
Fujita Health University Hospital ( Site 3419)
Toyoake
Kanagawa Cancer Center ( Site 3404)
Yokohama
Malaysia
Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502)
Kota Bharu
Sarawak General Hospital-Radiotherapy Unit ( Site 3500)
Kuching
National Cancer Institute-Radiotherapy and Oncology ( Site 3504)
Putrajaya
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706)
Guadalajara
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Hematologia and Oncologia ( Site 0704)
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0701)
Oaxaca City
Clinica Integral Internacional de Oncología ( Site 0705)
Puebla City
Philippines
THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600)
Iloilo City
Manila Doctors Hospital-Clinical Trial Office ( Site 3604)
Manila
Asian Hospital and Medical Center ( Site 3605)
Muntinlupa
THE MEDICAL CITY-Cancer Research Center ( Site 3603)
Pasig
ST. LUKE'S MEDICAL CENTER ( Site 3601)
Quezon City
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602)
San Juan City, Metro Manila
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
Bydgoszcz
Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)
Gliwice
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005)
Kielce
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
Przemyśl
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009)
Torun
Instytut Gruźlicy i Chorób Płuc w Warszawie ( Site 2011)
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
Warsaw
Republic of Korea
Pusan National University Hospital ( Site 3805)
Busan
Chungbuk National University Hospital-Internal medicine ( Site 3809)
Cheongju-si
National Cancer Center-Lung Cancer Center ( Site 3810)
Goyang-si
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807)
Hwasun
Chungnam national university hospital ( Site 3808)
Junggu
Seoul National University Bundang Hospital ( Site 3806)
Seongnam
Asan Medical Center ( Site 3801)
Seoul
Kangbuk Samsung Hospital ( Site 3813)
Seoul
Konkuk University Medical Center ( Site 3812)
Seoul
Korea University Guro Hospital-Internal Medicine ( Site 3800)
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)
Seoul
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804)
Seoul
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803)
Suwon
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811)
Yangsan
Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304)
Barcelona
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300)
Barcelona
Hospital Insular de Gran Canaria-Oncology ( Site 2305)
Las Palmas De Gran Canaria
Clinica Universidad de Navarra-Medical Oncology ( Site 2306)
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303)
Madrid
H.R.U Málaga - Hospital General-Oncology ( Site 2302)
Málaga
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301)
Pozuelo De Alarcón
Taiwan
Changhua Christian Hospital ( Site 3908)
Changhua
National Taiwan University Hospital - Hsinchu branch ( Site 3907)
Hsinchu
Chang Gung Memorial Hospital at Kaohsiung ( Site 3906)
Kaohsiung City
E-Da hospital ( Site 3911)
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912)
Kaohsiung City
Chi Mei Medical Center ( Site 3910)
Tainan
National Cheng Kung University Hospital ( Site 3909)
Tainan
Mackay Memorial Hospital-Chest Medicine ( Site 3902)
Taipei
National Taiwan University Hospital-Oncology ( Site 3904)
Taipei
Taipei Medical University Hospital ( Site 3900)
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 3903)
Taipei City
Thailand
Faculty of Medicine Siriraj Hospital ( Site 4000)
Bangkok
Songklanagarind hospital ( Site 4001)
Hat Yai
Faculty of Medicine - Khon Kaen University ( Site 4004)
Khon Kaen
Lampang Cancer Hospital ( Site 4005)
Muang
Maharaj Nakorn Chiang Mai Hospital ( Site 4003)
Muang
Sunpasitthiprasong Hospital-Oncology ( Site 4002)
Ubon Ratchathani
Turkey
Adana Medical Park Seyhan Hastanesi ( Site 2506)
Adana
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501)
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
Ankara
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504)
Bornova
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
Istanbul
Medipol Mega Universite Hastanesi-oncology ( Site 2505)
Stanbul
United Kingdom
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603)
London
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606)
London
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600)
London
The Christie NHS Foundation Trust ( Site 2604)
Manchester
The Clatterbridge Cancer Centre ( Site 2602)
Metropolitan Borough Of Wirral
Royal Marsden Hospital (Sutton) ( Site 2605)
Sutton
Viet Nam
Hanoi Oncology Hospital ( Site 4102)
Hanoi
K Hospital - National Cancer Hospital ( Site 4105)
Hanoi
National Lung Hospital-Oncology Department ( Site 4104)
Hanoi
Time Frame
Start Date: 2023-11-12
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

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