Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Biological: Ivonescimab Injection; Biological: Pembrolizumab Injection

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

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Summit Clinical Trial Information; Phone Number: 1-833-256-0522; Email: medicalinformation@smmttx.com

Study Locations

• Belgium
  • Louvain-la-Neuve, Belgium, 6800
    • Recruiting
    • CHU UC Louvain Namur
  • Ronse, Belgium, 9600
    • Recruiting
    • AZ Glorieux
• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • Recruiting
      • London Regional (LRCP)
    • Ottawa, Ontario, Canada, K1H8L6
      • Recruiting
      • Ottawa Cancer Center
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T7T1
      • Recruiting
      • Saskatchewan Cancer
• China
  • Beijing, China, 100044
    • Recruiting
    • Peking University People's Hospital
  • Beijing, China, 100021
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Science
  • Beijing, China, 100853
    • Recruiting
    • The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army
  • Changsha, China, 410013
    • Recruiting
    • Hunan Cancer Hospital Thoracic Medicine 2
  • Guangxi, China, 530021
    • Recruiting
    • Guangxi Medical University Cancer Hospital
  • Zhejiang, China, 310009
    • Recruiting
    • the Second Affiliated Hospital Zhejiang University School of Medicine
  • Anhui
    • Yangzhou, Anhui, China, 236010
      • Recruiting
      • Fu Yang People's Hospital
  • Beijing Municipality
    • Tongzhou, Beijing Municipality, China, 101125
      • Recruiting
      • Beijing Chest Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730013
      • Recruiting
      • Gansu Provincial Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510230
      • Recruiting
      • Fujian Cancer Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China, 190000
      • Recruiting
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Anyang, Henan, China, 471023
      • Recruiting
      • Henan University of Science and Technology Affiliated Anyang Cancer Hospital
    • Nanyang, Henan, China, 473001
      • Recruiting
      • Nanyang Central Hospital
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
  • Hubei
    • Jingzhou, Hubei, China, 434023
      • Recruiting
      • The First Affiliated Hospital of Yangtze University
    • Xiangyang, Hubei, China, 441100
      • Recruiting
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital Thoracic Medicine 1
    • Hengyang, Hunan, China, 421001
      • Recruiting
      • The First Affiliated Hospital of University of South China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221006
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
    • Xuzhou, Jiangsu, China, 2210000
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • Recruiting
      • First Affiliated Hospital of Gannan Medical University
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330209
      • Recruiting
      • Jiangxi Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710049
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Xi'an, Shaanxi, China, 710004
      • Recruiting
      • The Second Affiliated Hospital of AFMU
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
    • Linyi, Shandong, China, 276001
      • Recruiting
      • Linyi People's Hospital
    • Qingdao, Shandong, China, 266042
      • Recruiting
      • Qingdao Central Hospital
  • Shanghai Municipality
    • Xuhui, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
    • Xuhui, Shanghai Municipality, China, 200940
      • Recruiting
      • Shanghai Chest Hospital
    • Yangpu, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Recruiting
      • Shanxi Provincial Cancer Hospital
  • Sichuan
    • Mianyang, Sichuan, China, 621099
      • Recruiting
      • Mianyang Central Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • Recruiting
      • Cancer Hospital affiliated to Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Recruiting
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
    • Hanzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital,Zhejiang University
    • Jinhua, Zhejiang, China, 321000
      • Recruiting
      • Jinhua Municipal Central Hospital
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • Ningbo Medical Center Lihuili Hospital
    • Taizhou, Zhejiang, China, 31700
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
• France
  • Brest, France, 29200
    • Recruiting
    • Centre Hospitalier Regional Universitaire (CHRU) Brest
  • Caen, France, 14033
    • Recruiting
    • Centre Hospitalier Universitaire (CHU) de Caen
  • Caen, France, 14059
    • Recruiting
    • Unicancer - Centre François Baclesse (CFB)
  • Créteil, France, 94010
    • Recruiting
    • Centre Hospitalier Intercommunal de Creteil (CHIC
  • Le Mans, France, 72000
    • Recruiting
    • Centre de Cancérologie de la Sarthe
  • Marseille, France, 13915
    • Recruiting
    • Hôpital Nord
  • Montpellier, France, 34295
    • Recruiting
    • Centre Hospitalier Universitaire de Montpellier (CHU Montpellier)
  • Paris, France, 75000
    • Recruiting
    • Institut Curie
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Centre Hospitalier Lyon-Sud
  • Quimper, France, 29107
    • Recruiting
    • Centre Hospitalier (Intercommunal) De Cornouaille Quimper
  • Rennes, France, 35033
    • Recruiting
    • Centre Hospitalier Universitaire (CHU) de Rennes
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de Cancérologie de l'Ouest
  • Strasbourg, France, 67033
    • Recruiting
    • Institut de cancérologie Strasbourg Europe (ICANS)
  • Tours, France, 37044
    • Recruiting
    • Centre Hospitalier Regional et Universitaire de Tours
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy Oncologie Médical
• Germany
  • Esslingen am Neckar, Germany, 73730
    • Recruiting
    • Klinikum Esslingen GmbH
  • Frankfurt, Germany, 60488
    • Recruiting
    • Krankenhaus Nordwest GmbH
  • Gauting, Germany, 82131
    • Recruiting
    • Asklepios Klinik Gauting GmbH
  • Giesen, Germany, 35392
    • Recruiting
    • Universitaetsklinikum Giessen und Marburg
  • Heidelberg, Germany, 69126
    • Recruiting
    • Universitaetsklinikum Heidelberg (UKHD)
  • Jena, Germany, 07747
    • Recruiting
    • Universitaetsklinikum Jena
  • Kempten, Germany, 87435
    • Recruiting
    • Klinikverbund Allgaeu - Klinikum Kempte
  • Lübeck, Germany, 23538
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein
  • Munich, Germany, 81975
    • Recruiting
    • München Klinik gGmbH
• Greece
  • Athens, Greece, 15562
    • Recruiting
    • Metropolitan General Hospital
  • Athens, Greece, 11526
    • Recruiting
    • Henry Dunant Hospital Center
  • Athens, Greece, 11528
    • Recruiting
    • General Hospital of Athens Alexandra
  • Athens, Greece, 11527
    • Recruiting
    • General Hospital of Athens
  • Athens, Greece, 57010
    • Recruiting
    • Interbalkan Medical Center of Thessaloniki
  • Pátrai, Greece, 26504
    • Recruiting
    • University General Hospital of Patras
  • Pátrai, Greece, 26443
    • Recruiting
    • Olympion Hospital
  • Thessaloniki, Greece, 54622
    • Recruiting
    • Galenos General Clinic
  • Thessaloniki, Greece, 57010
    • Recruiting
    • "George Papanikolaou" General Hospital of Thessaloniki
• Ireland
  • Dublin, Ireland, D09V2N0
    • Recruiting
    • Beaumont Hospital
  • Dublin, Ireland, D08 NHY1
    • Recruiting
    • St. James's Hospital (SJH)
  • Galway, Ireland, H91 YR71
    • Recruiting
    • Galway Univeristy Hospitals
• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • Azienda Ospedaliero Universitaria delle Marche
  • Aviano, Italy, 33081
    • Recruiting
    • Centro di Riferimento Oncologico di Aviano
  • Cremona, Italy, 26100
    • Recruiting
    • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • Genova, Italy, 16149
    • Recruiting
    • Istituto Europeo di Oncologia (IEO)
  • Lucca, Italy, 55100
    • Recruiting
    • Ospedale San Luca
  • Milan, Italy, 20133
    • Recruiting
    • Istituto Europeo di Oncologia (IEO)
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
  • Monza, Italy, 20900
    • Recruiting
    • Fondazione IRCCS San Gerardo dei Tintori
  • Naples, Italy, 80131
    • Recruiting
    • Universita degli Studi della Campania "Luigi Vanvitelli"
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Pesaro, Italy, 61122
    • Recruiting
    • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
  • Peschiera del Garda, Italy, 37019
    • Recruiting
    • Ospedale P. Pederzoli
  • Roma, Italy, 00144
    • Recruiting
    • Istituti Fisioterapici Ospitalieri (IFO)
  • Siena, Italy, 53100
    • Recruiting
    • Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori
  • Verona, Italy, 37134
    • Recruiting
    • Ospedale G.B. Rossi Borgo Roma
• Japan
  • Aichi, Japan, 470-1192
    • Recruiting
    • Fujita Health University Hospital
  • Fukuoka, Japan, 810-8563
    • Recruiting
    • National Hospital Organization Kyusyu Medical Center
  • Hirosaki, Japan, 036-8563
    • Recruiting
    • Hirosaki University Hospital
  • Hiroshima, Japan, 734-8551
    • Recruiting
    • Hiroshima University Hospital
  • Hokkaido, Japan, 003-0804
    • Recruiting
    • National Hospital Organization - Hokkaido Cancer Center
  • Hokkaido, Japan, 040-8611
    • Recruiting
    • Hakodate Goryoukaku Hospital
  • Kashihara, Japan, 634-8522
    • Recruiting
    • Nara Medical University Hospital
  • Matsumoto, Japan, 390-8621
    • Recruiting
    • Shinshu University Hospital
  • Miyagi, Japan, 981-0914
    • Recruiting
    • Sendai Kousei Hospital
  • Okayama, Japan, 700-8558
    • Recruiting
    • Okayama University Hospital
  • Osaka, Japan, 573-1191
    • Recruiting
    • Kansai Medical University Hospital
  • Osaka, Japan, 569-8686
    • Recruiting
    • Osaka Medical and Pharmaceutical University Hospital (OMPU Hp)
  • Shizuoka, Japan, 411-8777
    • Recruiting
    • Shizuoka Cancer Center (SCC)
  • Tokyo, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital (NCCH)
  • Tokyo, Japan, 135-8550
    • Recruiting
    • The Cancer institute Hospital
  • Yamaguchi, Japan, 755-0241
    • Recruiting
    • National Hospital Organization Yamaguchi Ube Medical Center
  • Yokohama, Japan, 241-8515
    • Recruiting
    • Kanagawa Cancer Center
  • Yonago, Japan, 683-8504
    • Recruiting
    • Tottori University Hospital
• Mexico
  • Guadalajara, Mexico, 44670
    • Recruiting
    • Panamerican Clinical Research S.A de C.V.
  • Guadalajara, Mexico, 44680
    • Recruiting
    • Actualidad Basada en Investigación del Cáncer
  • Guadalajara, Mexico, 44680
    • Recruiting
    • Renati Innovation S.A.P.I. DE C.V.
  • La Paz, Mexico, 23040
    • Recruiting
    • Centro de Atencion Oncologica Viva
  • Mexico City, Mexico, 03100
    • Recruiting
    • Health Pharma Professional Research S.A. de C.V.
  • Mexico City, Mexico, 03720
    • Recruiting
    • Centro de Investigacion Clinica Gramel
  • Mexico City, Mexico, 06700
    • Recruiting
    • Arké SMO S.A de C.V
  • Mexico City, Mexico, 06760
    • Recruiting
    • Centro de Atencion Oncologica Viva
  • Monterrey, Mexico, 64710
    • Recruiting
    • I Can Oncology Center
  • Monterrey, Mexico, 64460
    • Recruiting
    • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Monterrey, Mexico, 64060
    • Recruiting
    • Althian Clinical Research
  • Monterrey, Mexico, 64060
    • Recruiting
    • CRI Centro Regiomontano de Investigación S.C.
• Poland
  • Bydgoszcz, Poland, 85796
    • Recruiting
    • Centrum Onkologii Im. Prof. F. Lukaszczyka W Bydgoszczy
  • Lodz, Poland, 90-302
    • Recruiting
    • Instytut MSF Sp. z o.o.
  • Poznan, Poland, 60-693
    • Recruiting
    • Med Polonia Sp. z o.o. NSZOZ
  • Prabuty, Poland, 82-550
    • Recruiting
    • Szpital Specjalistyczny W Prabutach
  • Warsaw, Poland, 04-141
    • Recruiting
    • Wojskowy Instytut Medczny
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Acibadem Bel Medic General Hospital
  • Belgrade, Serbia, 11000
    • Recruiting
    • Klinicki Centar Srbije
  • Belgrade, Serbia, 11040
    • Recruiting
    • Vojnomedicinska Akademija (VMA)
  • Belgrade, Serbia, 11080
    • Recruiting
    • Klinicko Bolnicki Centar (KBC) Bezanijska Kosa
  • Kamenica, Serbia, 21204
    • Recruiting
    • Institut Za Plucne Bolesti Vojvodine Klinika za pulmolosku onkologiju
  • Kragujevac, Serbia, 34000
    • Recruiting
    • Univerzitetski klinicki centar Kragujevac
  • Niš, Serbia, 18000
    • Recruiting
    • University Clinical Center Niš
• Spain
  • Badajoz, Spain, 06080
    • Recruiting
    • Hospital Universitario de Badajoz
  • Badalona, Spain, 08916
    • Recruiting
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain, 08028
    • Recruiting
    • Hospital Universitari Dexeus
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i de Sant Pau
  • Barcelona, Spain, 08003
    • Recruiting
    • Instituto Oncologico Baselga (IOB)
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron University
  • Barcelona, Spain, 08107
    • Recruiting
    • Mi Tres Torres
  • Girona, Spain, 17007
    • Recruiting
    • Institut d'Investigacio Biomedica de Girona Dr. Josep Trueta
  • Jaén, Spain, 23007
    • Recruiting
    • Hospital Universitario de Jaén
  • Las Palmas de Gran Canaria, Spain, 35016
    • Recruiting
    • Universidad de Las Palmas de Gran Canaria
  • Lugo, Spain, 27003
    • Recruiting
    • Hospital Universitario Lucus Augusti (HULA)
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Recruiting
    • Universidad Autonoma de Madrid (UAM)
  • Málaga, Spain, 29011
    • Recruiting
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Universidad de Navarra (CUN) - Pamplona
  • Seville, Spain, 41013
    • Recruiting
    • H Universitario Virgen Del Rocio
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia (CHUV)
  • Valencia, Spain, 46206
    • Recruiting
    • Hospital La Fe Bulevar Sur
  • Vigo, Spain, 36312
    • Recruiting
    • Hospital Alvaro Cunqueiro (HAC)
• Sweden
  • Stockholm, Sweden, 141 86
    • Recruiting
    • Karolinska University Hospital
  • Uppsala, Sweden, 803 24
    • Recruiting
    • Region Gävleborg Gävle Sjukhus Gävle Sjukhus
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Recruiting
    • Memorial Ankara Hospital
  • Ankara, Turkey (Türkiye), 06590
    • Recruiting
    • Gazi University Medicine Faculty Hospital
  • Diyarbakır, Turkey (Türkiye), 21280
    • Recruiting
    • Dicle University
  • Gaziantep, Turkey (Türkiye), 27584
    • Recruiting
    • Medical Point Gaziantep Hospital
  • Istanbul, Turkey (Türkiye), 34180
    • Recruiting
    • Memorial Saglik Grubu Bahçelievler Hospital
  • Istanbul, Turkey (Türkiye), 34460
    • Recruiting
    • Istinye University Bahceshir Liv Hospital
  • Istanbul, Turkey (Türkiye), 34098
    • Recruiting
    • İstanbul University Cerrahpasa Medical
  • Konya, Turkey (Türkiye), 42080
    • Recruiting
    • Necmettin Erbakan University Meram Medical Faculty Hospital
  • İzmit, Turkey (Türkiye), 34460
    • Recruiting
    • Kocaeli University Hospital
• United Kingdom
  • Leeds, United Kingdom, LS2 9JT
    • Recruiting
    • Leeds Teaching Hospitals NHS
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • St. Bartholomew's Hospital
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Banner University Medical Center
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • TMC HealthCare
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Recruiting
      • Genesis Cancer and Blood Institute
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • LA Cancer Network
    • Cerritos, California, United States, 90703
      • Recruiting
      • The Oncology Institute of Hope & Innovation
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California (USC)
    • Los Angeles, California, United States, 90067
      • Recruiting
      • Valkyrie Clinical Trials
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedar Sinai Medical Center
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Medical Center
    • Sacramento, California, United States, 95816
      • Recruiting
      • Sutter Institute for Medical Research
    • Santa Monica, California, United States, 90404
      • Recruiting
      • University of California Los Angeles (UCLA)
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Providence Medical Foundation
    • Vallejo, California, United States, 94589
      • Recruiting
      • Kaiser Permanente
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Rocky Mountain Cancer
    • Loveland, Colorado, United States, 80538
      • Recruiting
      • Banner MD Anderson Cancer Center at North Colorado Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06053
      • Recruiting
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • Florida Cancer Specialists & Research Institute (FCS)-East
    • Hialeah, Florida, United States, 33013
      • Recruiting
      • Bioresearch Partner- Hialeah Hospital
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Cancer Specialists of North Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
    • Ocala, Florida, United States, 34474
      • Recruiting
      • Ocala Oncology
    • Palm Bay, Florida, United States, 32901
      • Recruiting
      • Cancer Care of Brevard
    • Pembroke Pines, Florida, United States, 33028
      • Recruiting
      • Memorial Cancer Institute
    • Pensacola, Florida, United States, 32504
      • Recruiting
      • Ascension Sacred Heart Health System
    • Plantation, Florida, United States, 33322
      • Recruiting
      • BRCR Medical Center Inc
    • St. Petersburg, Florida, United States, 33705
      • Recruiting
      • Florida Cancer Specialists & Research Institute (FCS) - North
    • St. Petersburg, Florida, United States, 33709
      • Recruiting
      • Exigent Network
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • BRCR Medical Center Inc.
    • West Palm Beach, Florida, United States, 33401
      • Recruiting
      • Florida Cancer Specialists & Research Institute (FCS)-South
  • Georgia
    • Macon, Georgia, United States, 31210
      • Recruiting
      • Central Georgia Cancer Care
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
    • Peoria, Illinois, United States, 61615
      • Recruiting
      • Illinois Cancer Care
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Recruiting
      • University of Kansas Cancer Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Recruiting
      • Baptist Health
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Recruiting
      • Ascension Saint Agnes Hospital
    • Baltimore, Maryland, United States, 21187
      • Recruiting
      • Sidney Kimmel Comprehensive Cancer Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Recruiting
      • Lahey Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Recruiting
      • Trinity Health
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Insitute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55101
      • Recruiting
      • Park Nicollet Institute
      • Contact: Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Recruiting
      • American Oncology Partners, PA
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University St.Louis
  • Montana
    • Billings, Montana, United States, 59102
      • Recruiting
      • St. Vincent Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Recruiting
      • University of Nebraska Medical Center (UNMC)
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai
    • Syracuse, New York, United States, 13210
      • Recruiting
      • SUNY Upstate Medical University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Oncology Hematology Care (OHC), Inc
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Case Medical Center
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Willamette Valley Cancer Institute and Research Center (WVCI)
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina (MUSC)
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health-Upstate
  • Tennessee
    • Memphis, Tennessee, United States, 38138
      • Recruiting
      • West Cancer Center
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI-Nashville
  • Texas
    • Austin, Texas, United States, 78745
      • Recruiting
      • Texas Oncology- Austin
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Texas Oncology-Dallas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Md Anderson Cancer Center
      • Contact: Jianjun Zhang, MD; Phone Number: 713-563-6096; Email: jzhang20@mdanderson.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
    • San Antonio, Texas, United States, 78216
      • Recruiting
      • Texas Oncology-San Antonio
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology-Tyler
    • Tyler, Texas, United States, 75708
      • Recruiting
      • University of Texas at Tyler
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Oncology Associates
    • Reston, Virginia, United States, 20190
      • Recruiting
      • Virginia Cancer
  • Washington
    • Seattle, Washington, United States, 98103
      • Recruiting
      • Swedish Cancer Institute
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Cancer Care NW Centers
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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) or Tumor Cells (TC) 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

Exclusion Criteria:

• Histologic or cytopathologic evidence of the presence of small cell lung carcinoma

• Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.

  • For non-squamous histology patients, actionable driver mutation testing results are required before randomization.
• Has received any prior therapy for NSCLC in the metastatic setting
• Tumor invasion, encasement of organs (e.g. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A - Ivonescimab and chemotherapy; Subject will receive ivonescimab and chemotherapy	Biological: Ivonescimab Injection; Subject will receive ivonescimab and chemotherapy as an IV injection
Active Comparator: Arm B - Pembrolizumab and chemotherapy; Subject will receive pembrolizumab and chemotherapy	Biological: Pembrolizumab Injection; Subject will receive pembrolizumab and chemotherapy as an IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall Survival (OS) in the ITT population	approximately 4 years
Progression Free Survival (PFS)	Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1	approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event (AE)	incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results	From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, up to 2 years.

Collaborators and Investigators

• Sponsor: Summit Therapeutics
• Investigators: Study Director: Indu Lal, Summit Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; pembrolizumab
• Other Study ID Numbers: SMT112-3003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No