Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Start Date
10/26/2023
Completion Date
12/31/2029
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.
Detailed Description
This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Ivonescimab Injection
Pembrolizumab Injection
Conditions
Locations
Banner University Medical Center
Phoenix, Arizona 85006
United States
TMC Healthcare
Tucson, Arizona 85711
United States
Genesis Cancer and Blood Institute
Hot Springs, Arkansas 71913
United States
University of Arkansas
Little Rock, Arkansas 72205
United States
LA Cancer Network
Anaheim, California 92801
United States
The Oncology Institute of Hope & Innovation
Cerritos, California 90703
United States
University of Southern California (USC)
Los Angeles, California 90033
United States
Cedar Sinai Medical Center
Los Angeles, California 90048
United States
Valkyrie Clinical Trials
Los Angeles, California 90067
United States
Sutter Institute for Medical Research
Sacramento, California 95816
United States
UC Davis Medical Center
Sacramento, California 95817
United States
University of California Los Angeles (UCLA)
Santa Monica, California 90404
United States
Providence Medical Foundation
Santa Rosa, California 95403
United States
Kaiser Permanente
Vallejo, California 94589
United States
Rocky Mountain Cancer
Lone Tree, Colorado 80124
United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Loveland, Colorado 80538
United States
Hartford Hospital
Hartford, Connecticut 06053
United States
Yale University
New Haven, Connecticut 06510
United States
Florida Cancer Specialists & Research Institute (FCS)-East
Fort Myers, Florida 33901
United States
BioResearch Partner- Hialeah Hospital
Hialeah, Florida 33013
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
Cancer Specialists of North Florida
Jacksonville, Florida 32256
United States
Ocala Oncology
Ocala, Florida 34474
United States
Cancer Care of Brevard
Palm Bay, Florida 32901
United States
Memorial Cancer Institute
Pembroke Pines, Florida 33028
United States
Ascension Sacred Heart Health System
Pensacola, Florida 32504
United States
BRCR Medical Center Inc
Plantation, Florida 33322
United States
Florida Cancer Specialists & Research Institute (FCS) - North
St. Petersburg, Florida 33705
United States
Exigent Network
St. Petersburg, Florida 33709
United States
BRCR Medical Center Inc.
Tamarac, Florida 33321
United States
Florida Cancer Specialists & Research Institute (FCS)-South
West Palm Beach, Florida 33401
United States
Central Georgia Cancer Care
Macon, Georgia 31210
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
Illinois Cancer Care
Peoria, Illinois 61615
United States
University of Kansas Cancer Center
Westwood, Kansas 66205
United States
Baptist Health
Lexington, Kentucky 40503
United States
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21187
United States
Ascension Saint Agnes Hospital
Baltimore, Maryland 21229
United States
Lahey Hospital
Burlington, Massachusetts 01805
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Trinity Health
Ann Arbor, Michigan 48197
United States
Karmanos Cancer Insitute
Detroit, Michigan 48201
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Park Nicollet Institute
Saint Paul, Minnesota 55101
United States
American Oncology Partners, PA
Kansas City, Missouri 64132
United States
Washington University St.Louis
St Louis, Missouri 63110
United States
St. Vincent Cancer Center
Billings, Montana 59102
United States
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska 68105
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Mount Sinai
New York, New York 10029
United States
Memorial Sloan Kettering
New York, New York 10065
United States
SUNY Upstate Medical University
Syracuse, New York 13210
United States
University of North Carolina
Chapel Hill, North Carolina 27514
United States
Levine Center
Charlotte, North Carolina 28204
United States
Oncology Hematology Care (OHC), Inc
Cincinnati, Ohio 45242
United States
University Hospitals Case Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Willamette Valley Cancer Institute and Research Center (WVCI)
Eugene, Oregon 97401
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
Prisma Health-Upstate
Greenville, South Carolina 29605
United States
West Cancer Center
Memphis, Tennessee 38138
United States
SCRI-Nashville
Nashville, Tennessee 37203
United States
Texas Oncology- Austin
Austin, Texas 78745
United States
Texas Oncology-Dallas
Dallas, Texas 75246
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Texas Oncology-San Antonio
San Antonio, Texas 78216
United States
Texas Oncology-Tyler
Tyler, Texas 75702
United States
University of Texas at Tyler
Tyler, Texas 75708
United States
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Virginia Cancer
Reston, Virginia 20190
United States
Swedish Cancer Institute
Seattle, Washington 98103
United States
Cancer Care NW Centers
Spokane, Washington 99202
United States
Carbone Cancer Center
Madison, Wisconsin 53792
United States
CHU UC Louvain Namur
Louvain-la-Neuve, 6800
Belgium
az Glorieux
Ronse, 9600
Belgium
London Regional (LRCP)
London, Ontario N6A5W9
Canada
Ottawa Cancer Center
Ottawa, Ontario K1H8L6
Canada
Saskatchewan Cancer
Regina, Saskatchewan S4T7T1
Canada
Fu Yang People's Hospital
Yangzhou, Anhui 236010
China
Beijing Chest Hospital
Tongzhou, Beijing Municipality 101125
China
Fujian Cancer Hospital
Fuzhou, Fujian 350014
China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu 730013
China
Fujian Cancer Hospital
Guangzhou, Guangdong 510230
China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530000
China
Hainan General Hospital
Haikou, Hainan 190000
China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050011
China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150081
China
Henan University of Science and Technology Affiliated Anyang Cancer Hospital
Anyang, Henan 471023
China
Nanyang Central Hospital
Nanyang, Henan 473001
China
Henan Cancer Hospital
Zhengzhou, Henan 450003
China
The First Affiliated Hospital of Yangtze University
Jingzhou, Hubei 434023
China
Xiangyang Central Hospital
Xiangyang, Hubei 441100
China
Xiangya Hospital of Central South University
Changsha, Hunan 410000
China
Hunan Cancer Hospital Thoracic Medicine 1
Changsha, Hunan 410013
China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan 421001
China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 2210000
China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221006
China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi 341000
China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
China
Jiangxi Cancer Hospital
Nanchang, Jiangxi 330209
China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning 110004
China
The Second Affiliated Hospital of AFMU
Xi'an, Shaanxi 710004
China
The first affiliated Hospital of xi'an jiao tong university
Xi'an, Shaanxi 710049
China
Shandong Cancer Hospital
Jinan, Shandong 250117
China
Linyi People's Hospital
Linyi, Shandong 276001
China
Qingdao Central Hospital
Qingdao, Shandong 266042
China
Fudan University Shanghai Cancer Center
Xuhui, Shanghai Municipality 200032
China
Shanghai Chest Hospital
Xuhui, Shanghai Municipality 200940
China
Shanghai Pulmonary Hospital
Yangpu, Shanghai Municipality 200433
China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030013
China
Mianyang Central Hospital
Mianyang, Sichuan 621099
China
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, Xinjiang 830011
China
Yunnan Cancer Hospital
Kunming, Yunnan 650118
China
The First Affiliated Hospital,Zhejiang University
Hanzhou, Zhejiang 310003
China
Zhejiang Cancer Hospital
Hanzhou, Zhejiang 310022
China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang 321000
China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang 315010
China
TaiZhou Hospital Of Zhejiang Province
Taizhou, Zhejiang 31700
China
Cancer Hospital Chinese Academy of Medical Science
Beijing, 100021
China
Peking University People's Hospital
Beijing, 100044
China
The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army
Beijing, 100853
China
Hunan Cancer Hospital Thoracic Medicine 2
Changsha, 410013
China
Guangxi Medical University Cancer Hospital
Guangxi, 530021
China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, 310009
China
Centre Hospitalier Regional Universitaire (CHRU) Brest
Brest, 29200
France
Centre Hospitalier Universitaire (CHU) de Caen
Caen, 14033
France
Unicancer - Centre François Baclesse (CFB)
Caen, 14059
France
Centre Hospitalier Intercommunal de Creteil (CHIC
Créteil, 94010
France
Centre de Cancérologie de la Sarthe
Le Mans, 72000
France
Hopital Nord
Marseille, 13915
France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier)
Montpellier, 34295
France
Institut Curie
Paris, 75000
France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
France
Centre Hospitalier (Intercommunal) De Cornouaille Quimper
Quimper, 29107
France
Centre Hospitalier Universitaire (CHU) de Rennes
Rennes, 35033
France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
France
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, 67033
France
Centre Hospitalier Regional et Universitaire de Tours
Tours, 37044
France
Gustave Roussy Oncologie Médical
Villejuif, 94800
France
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Germany
Krankenhaus Nordwest GmbH
Frankfurt, 60488
Germany
Asklepios Klinik Gauting GmbH
Gauting, 82131
Germany
Universitaetsklinikum Giessen und Marburg
Giesen, 35392
Germany
Universitaetsklinikum Heidelberg (UKHD)
Heidelberg, 69126
Germany
Universitaetsklinikum Jena
Jena, 07747
Germany
Klinikverbund Allgaeu - Klinikum Kempte
Kempten, 87435
Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Germany
München Klinik gGmbH
Munich, 81975
Germany
Henry Dunant Hospital Center
Athens, 11526
Greece
General Hospital of Athens
Athens, 11527
Greece
General Hospital of Athens Alexandra
Athens, 11528
Greece
Metropolitan General Hospital
Athens, 15562
Greece
Interbalkan Medical Center of Thessaloniki
Athens, 57010
Greece
Olympion Hospital
Pátrai, 26443
Greece
University General Hospital of Patras
Pátrai, 26504
Greece
Galenos General Clinic
Thessaloniki, 54622
Greece
"George Papanikolaou" General Hospital of Thessaloniki
Thessaloniki, 57010
Greece
St. James's Hospital (SJH)
Dublin, D08 NHY1
Ireland
Beaumont Hospital
Dublin, D09V2N0
Ireland
Galway Univeristy Hospitals
Galway, H91 YR71
Ireland
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Italy
Centro di Riferimento Oncologico di Aviano
Aviano, 33081
Italy
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, 26100
Italy
Istituto Europeo di Oncologia (IEO)
Genova, 16149
Italy
Ospedale San Luca
Lucca, 55100
Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
Milan, 20133
Italy
Istituto Europeo di Oncologia (IEO)
Milan, 20133
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Italy
Universita degli Studi della Campania "Luigi Vanvitelli"
Naples, 80131
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Italy
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
Pesaro, 61122
Italy
Ospedale P. Pederzoli
Peschiera del Garda, 37019
Italy
Istituti Fisioterapici Ospitalieri (IFO)
Roma, 00144
Italy
Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori
Siena, 53100
Italy
Ospedale G.B. Rossi Borgo Roma
Verona, 37134
Italy
Fujita Health University Hospital
Aichi, 470-1192
Japan
National Hospital Organization Kyusyu Medical Center
Fukuoka, 810-8563
Japan
Hirosaki University Hospital
Hirosaki, 036-8563
Japan
Hiroshima University Hospital
Hiroshima, 734-8551
Japan
National Hospital Organization - Hokkaido Cancer Center
Hokkaido, 003-0804
Japan
Hakodate Goryoukaku Hospital
Hokkaido, 040-8611
Japan
Nara Medical University Hospital
Kashihara, 634-8522
Japan
Shinshu University Hospital
Matsumoto, 390-8621
Japan
Sendai Kousei Hospital
Miyagi, 981-0914
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Osaka Medical and Pharmaceutical University Hospital (OMPU Hp)
Osaka, 569-8686
Japan
Kansai Medical University Hospital
Osaka, 573-1191
Japan
Shizuoka Cancer Center (SCC)
Shizuoka, 411-8777
Japan
National Cancer Center Hospital (NCCH)
Tokyo, 104-0045
Japan
The Cancer institute Hospital
Tokyo, 135-8550
Japan
National Hospital Organization Yamaguchi Ube Medical Center
Yamaguchi, 755-0241
Japan
Kanagawa Cancer Center
Yokohama, 241-8515
Japan
Tottori University Hospital
Yonago, 683-8504
Japan
Panamerican Clinical Research S.A de C.V.
Guadalajara, 44670
Mexico
Actualidad Basada en Investigación del Cáncer
Guadalajara, 44680
Mexico
Renati Innovation S.A.P.I. DE C.V.
Guadalajara, 44680
Mexico
Centro de Atención Oncológica Viva
La Paz, 23040
Mexico
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100
Mexico
Centro de Investigación Clínica GRAMEL
Mexico City, 03720
Mexico
Arke SMO S.A DE C.V
Mexico City, 06700
Mexico
Centro de Atención Oncológica Viva
Mexico City, 06760
Mexico
Althian Clinical Research
Monterrey, 64060
Mexico
CRI Centro Regiomontano de Investigación S.C.
Monterrey, 64060
Mexico
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, 64460
Mexico
I Can Oncology Center
Monterrey, 64710
Mexico
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, 85796
Poland
Instytut Msf Sp. z o.o.
Lodz, 90-302
Poland
Med Polonia Sp. z o.o. NSZOZ
Poznan, 60-693
Poland
Szpital Specjalistyczny w Prabutach
Prabuty, 82-550
Poland
Wojskowy Instytut Medczny
Warsaw, 04-141
Poland
Acibadem Bel Medic General Hospital
Belgrade, 11000
Serbia
Klinicki Centar Srbije
Belgrade, 11000
Serbia
Vojnomedicinska Akademija (VMA)
Belgrade, 11040
Serbia
Klinicko Bolnicki Centar (KBC) Bezanijska Kosa
Belgrade, 11080
Serbia
Institut Za Plucne Bolesti Vojvodine Klinika za pulmolosku onkologiju
Kamenica, 21204
Serbia
Univerzitetski Klinicki Centar Kragujevac
Kragujevac, 34000
Serbia
University Clinical Center Niš
Niš, 18000
Serbia
Hospital Universitario de Badajoz
Badajoz, 06080
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Spain
Instituto Oncologico Baselga (IOB)
Barcelona, 08003
Spain
Hospital de la Santa Creu i de Sant Pau
Barcelona, 08025
Spain
Hospital Universitari Dexeus
Barcelona, 08028
Spain
Vall d'Hebron University
Barcelona, 08035
Spain
Mi Tres Torres
Barcelona, 08107
Spain
Institut d'Investigacio Biomedica de Girona Dr. Josep Trueta
Girona, 17007
Spain
Hospital Universitario de Jaén
Jaén, 23007
Spain
Universidad de Las Palmas de Gran Canaria
Las Palmas de Gran Canaria, 35016
Spain
Hospital Universitario Lucus Augusti (HULA)
Lugo, 27003
Spain
Universidad Autonoma de Madrid (UAM)
Madrid, 28040
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Regional Universitario de Málaga
Málaga, 29011
Spain
Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, 31008
Spain
H Universitario Virgen Del Rocio
Seville, 41013
Spain
Hospital Clinico Universitario de Valencia (CHUV)
Valencia, 46010
Spain
Hospital La Fe Bulevar Sur
Valencia, 46206
Spain
Hospital Alvaro Cunqueiro (HAC)
Vigo, 36312
Spain
Karolinska University Hospital
Stockholm, 141 86
Sweden
Region Gävleborg Gävle Sjukhus Gävle Sjukhus
Uppsala, 803 24
Sweden
Memorial Ankara Hospital
Ankara, 06520
Turkey (Türkiye)
Gazi University Medicine Faculty Hospital
Ankara, 06590
Turkey (Türkiye)
Dicle University
Diyarbakır, 21280
Turkey (Türkiye)
Medical Point Gaziantep Hospital
Gaziantep, 27584
Turkey (Türkiye)
İstanbul University Cerrahpasa Medical
Istanbul, 34098
Turkey (Türkiye)
Memorial Saglik Grubu Bahçelievler Hospital
Istanbul, 34180
Turkey (Türkiye)
Istinye University Bahceshir Liv Hospital
Istanbul, 34460
Turkey (Türkiye)
Kocaeli University Hospital
İzmit, 34460
Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty Hospital
Konya, 42080
Turkey (Türkiye)
Leeds Teaching Hospitals NHS
Leeds, LS2 9JT
United Kingdom
St. Bartholomew's hospital
London, EC1A 7BE
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom