A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)
Status: Recruiting
Location: See all (219) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years old at the time of enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Expected life expectancy ≥ 3 months
• Metastatic (Stage IV) NSCLC
• Histologically or cytologically confirmed squamous or non-squamous NSCLC
• Recorded measurement of the Tumor Proportion Score (TPS) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization
• At least one measurable noncerebral lesion according to RECIST 1.1
• No prior systemic treatment for metastatic NSCLC
Locations
United States
Arkansas
University of Arkansas
RECRUITING
Little Rock
Arizona
TMC Healthcare
RECRUITING
Tucson
California
LA Cancer Network
RECRUITING
Anaheim
The Oncology Institute of Hope & Innovation
RECRUITING
Cerritos
Cedar Sinai Medical Center
RECRUITING
Los Angeles
University of Southern California (USC)
RECRUITING
Los Angeles
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Sutter Institute for Medical Research
RECRUITING
Sacramento
UC Davis Medical Center
RECRUITING
Sacramento
University of California Los Angeles (UCLA)
RECRUITING
Santa Monica
Providence Medical Foundation
RECRUITING
Santa Rosa
Kaiser Permanente
RECRUITING
Vallejo
Colorado
Rocky Mountain Cancer
RECRUITING
Lone Tree
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Florida
Florida Cancer Specialists & Research Institute (FCS)-East
RECRUITING
Fort Myers
BioResearch Partner- Hialeah Hospital
RECRUITING
Hialeah
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Ocala Oncology
RECRUITING
Ocala
Cancer Care of Brevard
RECRUITING
Palm Bay
Memorial Cancer Institute
RECRUITING
Pembroke Pines
Exigent Network
RECRUITING
Petersburg
BRCR
RECRUITING
Plantation
Florida Cancer Specialists & Research Institute (FCS) - North
RECRUITING
St. Petersburg
Florida Cancer Specialists & Research Institute (FCS)-South
RECRUITING
West Palm Beach
Illinois
Illinois Cancer Care
RECRUITING
Peoria
Kansas
University of Kansas Cancer Center
RECRUITING
Westwood
Kentucky
Baptist Health
RECRUITING
Lexington
Massachusetts
Lahey Hospital
RECRUITING
Burlington
Maryland
Sidney Kimmel Comprehensive Cancer Center
RECRUITING
Baltimore
Michigan
Trinity Health
RECRUITING
Ann Arbor
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Karmanos Cancer Insitute
RECRUITING
Detroit
Minnesota
Park Nicollet Institute
RECRUITING
Saint Paul
Missouri
American Oncology Partners, PA
RECRUITING
Kansas City
Washington University St.Louis
RECRUITING
St Louis
Montana
St. Vincent Cancer Center
RECRUITING
Billings
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Levine Center
RECRUITING
Charlotte
Nebraska
University of Nebraska Medical Center (UNMC)
RECRUITING
Omaha
New York
Memorial Sloan Kettering
RECRUITING
New York
Mount Sinai
RECRUITING
New York
Ohio
Oncology Hematology Care (OHC), Inc
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Case Medical Center
RECRUITING
Cleveland
Oregon
Willamette Valley Cancer Institute and Research Center (WVCI)
RECRUITING
Eugene
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Prisma Health-Upstate
RECRUITING
Greenville
Tennessee
West Cancer Center
RECRUITING
Memphis
SCRI-Nashville
RECRUITING
Nashville
Texas
Texas Oncology- Austin
RECRUITING
Austin
Texas Oncology-Dallas
RECRUITING
Dallas
UT Southwestern
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Texas Oncology-San Antonio
RECRUITING
San Antonio
Texas Oncology-Tyler
RECRUITING
Tyler
University of Texas at Tyler
RECRUITING
Tyler
Virginia
Virginia Oncology Associates
RECRUITING
Norfolk
Virginia Cancer
RECRUITING
Reston
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Cancer Care NW Centers
RECRUITING
Spokane
Wisconsin
Carbone Cancer Center
RECRUITING
Madison
Other Locations
Belgium
CHU UC Louvain Namur
RECRUITING
Louvain-la-neuve
Canada
London Regional (LRCP)
RECRUITING
London
Ottawa Cancer Center
RECRUITING
Ottawa
Saskatchewan Cancer
RECRUITING
Regina
China
Henan University of Science and Technology Affiliated Anyang Cancer Hospital
RECRUITING
Anyang
Cancer Hospital Chinese Academy of Medical Science
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army
RECRUITING
Beijing
Hunan Cancer Hospital Thoracic Medicine 1
RECRUITING
Changsha
Hunan Cancer Hospital Thoracic Medicine 2
RECRUITING
Changsha
Fujian Cancer Hospital
RECRUITING
Fuzhou
Guangxi Medical University Cancer Hospital
RECRUITING
Guangxi
Fujian Cancer Hospital
RECRUITING
Guangzhou
Hainan General Hospital
RECRUITING
Haikou
The First Affiliated Hospital,Zhejiang University
RECRUITING
Hanzhou
Zhejiang Cancer Hospital
RECRUITING
Hanzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The First Affiliated Hospital Of University Of South China
RECRUITING
Hengyang
Shandong Cancer Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Yangtze University
RECRUITING
Jingzhou
Jinhua Municipal Central Hospital
RECRUITING
Jinhua
Yunnan Cancer Hospital
RECRUITING
Kunming
Gansu Provincial Cancer Hospital
RECRUITING
Lanzhou
Linyi People's Hospital
RECRUITING
Linyi
Mianyang Central Hospital
RECRUITING
Mianyang
Jiangxi Cancer Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Nanyang Central Hospital
RECRUITING
Nanyang
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
Qingdao Central Hospital
RECRUITING
Qingdao
Shengjing Hospital Of China Medical University
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shanxi Provincial Cancer Hospital
RECRUITING
Taiyuan
TaiZhou Hospital Of Zhejiang Province
RECRUITING
Taizhou
Beijing Chest Hospital
RECRUITING
Tongzhou
Cancer Hospital Affiliated to Xinjiang Medical University
RECRUITING
Ürümqi
The first affiliated Hospital of xi'an jiao tong university
RECRUITING
Xi'an
Xiangyang Central Hospital
RECRUITING
Xiangyang
Fudan University Shanghai Cancer Center
RECRUITING
Xuhui
Shanghai Chest Hospital
RECRUITING
Xuhui
Shanghai Pulmonary Hospital
RECRUITING
Yangpu
Fu Yang People's Hospital
RECRUITING
Yangzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
France
Centre Hospitalier Regional Universitaire (CHRU) Brest
RECRUITING
Brest
Centre Hospitalier Universitaire (CHU) de Caen
RECRUITING
Caen
Unicancer - Centre François Baclesse (CFB)
RECRUITING
Caen
Centre Hospitalier Intercommunal de Creteil (CHIC
RECRUITING
Créteil
Centre de Cancérologie de la Sarthe
RECRUITING
Le Mans
Hopital Nord
RECRUITING
Marseille
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier)
RECRUITING
Montpellier
Institut Curie
RECRUITING
Paris
Centre Hospitalier Lyon-Sud
RECRUITING
Pierre-bénite
Centre Hospitalier (Intercommunal) De Cornouaille Quimper
RECRUITING
Quimper
Centre Hospitalier Universitaire (CHU) de Rennes
RECRUITING
Rennes
Institut de Cancérologie de l'Ouest
RECRUITING
Saint-herblain
Institut de cancérologie Strasbourg Europe (ICANS)
RECRUITING
Strasbourg
Centre Hospitalier Regional et Universitaire de Tours
RECRUITING
Tours
Gustave Roussy Oncologie Médical
RECRUITING
Villejuif
Germany
Klinikum Esslingen GmbH
RECRUITING
Esslingen Am Neckar
Krankenhaus Nordwest GmbH
RECRUITING
Frankfurt
Asklepios Klinik Gauting GmbH
RECRUITING
Gauting
Universitaetsklinikum Giessen und Marburg
RECRUITING
Giesen
Universitaetsklinikum Heidelberg (UKHD)
RECRUITING
Heidelberg
Universitaetsklinikum Jena
RECRUITING
Jena
Klinikverbund Allgaeu - Klinikum Kempte
RECRUITING
Kempten
Universitätsklinikum Schleswig-Holstein
RECRUITING
Lübeck
München Klinik gGmbH
RECRUITING
Munich
Greece
General Hospital of Athens
RECRUITING
Athens
General Hospital of Athens Alexandra
RECRUITING
Athens
Henry Dunant Hospital Center
RECRUITING
Athens
Interbalkan Medical Center of Thessaloniki
RECRUITING
Athens
Metropolitan General Hospital
RECRUITING
Athens
Olympion Hospital
RECRUITING
Pátrai
University General Hospital of Patras
RECRUITING
Pátrai
Galenos General Clinic
RECRUITING
Thessaloniki
George Papanikolaou General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Ireland
Beaumont Hospital
RECRUITING
Dublin
St. James's Hospital (SJH)
RECRUITING
Dublin
Galway Univeristy Hospitals
RECRUITING
Galway
Italy
Azienda Ospedaliero Universitaria delle Marche
RECRUITING
Ancona
Centro di Riferimento Oncologico di Aviano
RECRUITING
Aviano
Azienda Ospedaliera Istituti Ospitalieri di Cremona
RECRUITING
Cremona
Istituto Europeo di Oncologia (IEO)
RECRUITING
Genova
Ospedale San Luca
RECRUITING
Lucca
Istituto Europeo di Oncologia (IEO)
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Universita degli Studi della Campania Luigi Vanvitelli
RECRUITING
Naples
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
RECRUITING
Pesaro
Ospedale P. Pederzoli
RECRUITING
Peschiera Del Garda
Istituti Fisioterapici Ospitalieri (IFO)
RECRUITING
Roma
Ospedale G.B. Rossi Borgo Roma
RECRUITING
Verona
Japan
Fujita Health University Hospital
RECRUITING
Aichi
National Hospital Organization Kyusyu Medical Center
RECRUITING
Fukuoka
Hirosaki University Hospital
RECRUITING
Hirosaki
Hiroshima University Hospital
RECRUITING
Hiroshima
Hakodate Goryoukaku Hospital
RECRUITING
Hokkaido
National Hospital Organization - Hokkaido Cancer Center
RECRUITING
Hokkaido
Nara Medical University Hospital
RECRUITING
Kashihara
Shinshu University Hospital
RECRUITING
Matsumoto
Sendai Kousei Hospital
RECRUITING
Miyagi
Okayama University Hospital
RECRUITING
Okayama
Kansai Medical University Hospital
RECRUITING
Osaka
Osaka Medical and Pharmaceutical University Hospital (OMPU Hp)
RECRUITING
Osaka
Shizuoka Cancer Center (SCC)
RECRUITING
Shizuoka
National Cancer Center Hospital (NCCH)
RECRUITING
Tokyo
The Cancer institute Hospital
RECRUITING
Tokyo
National Hospital Organization Yamaguchi Ube Medical Center
RECRUITING
Yamaguchi
Kanagawa Cancer Center
RECRUITING
Yokohama
Tottori University Hospital
RECRUITING
Yonago
Mexico
Actualidad Basada en Investigación del Cáncer
RECRUITING
Guadalajara
Panamerican Clinical Research S.A de C.V.
RECRUITING
Guadalajara
Renati Innovation S.A.P.I. DE C.V.
RECRUITING
Guadalajara
Centro de Atención Oncológica Viva
RECRUITING
La Paz
Arke SMO S.A DE C.V
RECRUITING
Mexico City
Centro de Atención Oncológica Viva
RECRUITING
Mexico City
Centro de Investigación Clínica GRAMEL
RECRUITING
Mexico City
Health Pharma Professional Research S.A. de C.V.
RECRUITING
Mexico City
Althian Clinical Research
RECRUITING
Monterrey
CRI Centro Regiomontano de Investigación S.C.
RECRUITING
Monterrey
Hospital Universitario Dr. José Eleuterio González
RECRUITING
Monterrey
I Can Oncology Center
RECRUITING
Monterrey
Poland
Instytut Msf Sp. z o.o.
RECRUITING
Lodz
Med Polonia Sp. z o.o. NSZOZ
RECRUITING
Poznan
Szpital Specjalistyczny w Prabutach
RECRUITING
Prabuty
Wojskowy Instytut Medczny
RECRUITING
Warsaw
Serbia
Acibadem Bel Medic General Hospital
RECRUITING
Belgrade
Klinicki Centar Srbije
RECRUITING
Belgrade
Klinicko Bolnicki Centar (KBC) Bezanijska Kosa
RECRUITING
Belgrade
Vojnomedicinska Akademija (VMA)
RECRUITING
Belgrade
Institut Za Plucne Bolesti Vojvodine Klinika za pulmolosku onkologiju
RECRUITING
Kamenica
Univerzitetski Klinicki Centar Kragujevac
RECRUITING
Kragujevac
University Clinical Center Niš
RECRUITING
Niš
Spain
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i de Sant Pau
RECRUITING
Barcelona
Hospital Universitari Dexeus
RECRUITING
Barcelona
Instituto Oncologico Baselga (IOB)
RECRUITING
Barcelona
Mi Tres Torres
RECRUITING
Barcelona
Vall d'Hebron University
RECRUITING
Barcelona
Institut d'Investigacio Biomedica de Girona Dr. Josep Trueta
RECRUITING
Girona
Hospital Universitario de Jaén
RECRUITING
Jaén
Universidad de Las Palmas de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Lucus Augusti (HULA)
RECRUITING
Lugo
Hospital Universitario La Paz
RECRUITING
Madrid
Universidad Autonoma de Madrid (UAM)
RECRUITING
Madrid
Hospital Regional Universitario de Málaga
RECRUITING
Málaga
Clinica Universidad de Navarra (CUN) - Pamplona
RECRUITING
Pamplona
H Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Clinico Universitario de Valencia (CHUV)
RECRUITING
Valencia
Hospital La Fe Bulevar Sur
RECRUITING
Valencia
Hospital Alvaro Cunqueiro (HAC)
RECRUITING
Vigo
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Region Gävleborg Gävle Sjukhus Gävle Sjukhus
RECRUITING
Uppsala
United Kingdom
Leeds Teaching Hospitals NHS
RECRUITING
Leeds
St. Bartholomew's hospital
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Summit Clinical Trial Information
medicalinformation@smmttx.com
1-833-256-0522
Time Frame
Start Date: 2023-10-26
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1080
Treatments
Experimental: Arm A - Ivonescimab and chemotherapy
Subject will receive ivonescimab and chemotherapy
Active_comparator: Arm B - Pembrolizumab and chemotherapy
Subject will receive pembrolizumab and chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Summit Therapeutics