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
  • Ronse, Belgium, 9600
    • Active, not recruiting
    • AZ Glorieux
  • Yvoir, Belgium, 5530
    • Active, not recruiting
    • CHU UC Louvain Namur
• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • Active, not recruiting
      • London Regional (LRCP)
    • Ottawa, Ontario, Canada, K1H8L6
      • Active, not recruiting
      • Ottawa Cancer Center
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T7T1
      • Active, not recruiting
      • Saskatchewan Cancer
• China
  • Beijing, China, 100044
    • Active, not recruiting
    • Peking University People's Hospital
  • Beijing, China, 100021
    • Active, not recruiting
    • Cancer Hospital Chinese Academy of Medical Science
  • Beijing, China, 100853
    • Active, not recruiting
    • The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army
  • Changsha, China, 410013
    • Active, not recruiting
    • Hunan Cancer Hospital Thoracic Medicine 2
  • Guangxi, China, 530021
    • Active, not recruiting
    • Guangxi Medical University Cancer Hospital
  • Zhejiang, China, 310009
    • Active, not recruiting
    • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Anhui
    • Yangzhou, Anhui, China, 236010
      • Active, not recruiting
      • Fu Yang People's Hospital
  • Beijing Municipality
    • Tongzhou, Beijing Municipality, China, 101125
      • Active, not recruiting
      • Beijing Chest Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Active, not recruiting
      • Fujian Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730013
      • Active, not recruiting
      • Gansu Provincial Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510230
      • Active, not recruiting
      • Fujian Cancer Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Active, not recruiting
      • The First Affiliated Hospital of Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China, 190000
      • Active, not recruiting
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Active, not recruiting
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Active, not recruiting
      • Harbin medical university cancer hospital
  • Henan
    • Anyang, Henan, China, 471023
      • Active, not recruiting
      • Henan University of Science and Technology Affiliated Anyang Cancer Hospital
    • Nanyang, Henan, China, 473001
      • Active, not recruiting
      • Nanyang Central Hospital
    • Zhengzhou, Henan, China, 450003
      • Active, not recruiting
      • Henan Cancer Hospital
  • Hubei
    • Jingzhou, Hubei, China, 434023
      • Active, not recruiting
      • The First Affiliated Hospital of Yangtze University
    • Xiangyang, Hubei, China, 441100
      • Active, not recruiting
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Active, not recruiting
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410013
      • Active, not recruiting
      • Hunan Cancer Hospital Thoracic Medicine 1
    • Hengyang, Hunan, China, 421001
      • Active, not recruiting
      • The First Affiliated Hospital of University of South China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221006
      • Active, not recruiting
      • The Affiliated Hospital of Xuzhou Medical University
    • Xuzhou, Jiangsu, China, 2210000
      • Active, not recruiting
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • Active, not recruiting
      • First Affiliated Hospital of Gannan Medical University
    • Nanchang, Jiangxi, China, 330006
      • Active, not recruiting
      • The First Affiliated Hospital of NanChang University
    • Nanchang, Jiangxi, China, 330209
      • Recruiting
      • Jiangxi Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Active, not recruiting
      • Shengjing Hospital Of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Active, not recruiting
      • The Second Affiliated Hospital of AFMU
    • Xi'an, Shaanxi, China, 710049
      • Active, not recruiting
      • The First Affiliated Hospital of Xi'an Jiao Tong University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Active, not recruiting
      • Shandong Cancer Hospital
    • Linyi, Shandong, China, 276001
      • Active, not recruiting
      • Linyi People's Hospital
    • Qingdao, Shandong, China, 266042
      • Active, not recruiting
      • Qingdao Central Hospital
  • Shanghai Municipality
    • Xuhui, Shanghai Municipality, China, 200032
      • Active, not recruiting
      • Fudan University Shanghai Cancer Center
    • Xuhui, Shanghai Municipality, China, 200940
      • Active, not recruiting
      • Shanghai Chest Hospital
    • Yangpu, Shanghai Municipality, China, 200433
      • Active, not recruiting
      • Shanghai Pulmonary Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Active, not recruiting
      • Shanxi Provincial Cancer Hospital
  • Sichuan
    • Mianyang, Sichuan, China, 621099
      • Active, not recruiting
      • Mianyang Central Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • Active, not recruiting
      • Cancer Hospital affiliated to Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Active, not recruiting
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310003
      • Active, not recruiting
      • The First Affiliated Hospital,Zhejiang University
    • Hanzhou, Zhejiang, China, 310022
      • Active, not recruiting
      • Zhejiang Cancer Hospital
    • Jinhua, Zhejiang, China, 321000
      • Active, not recruiting
      • Jinhua municipal central hospital
    • Ningbo, Zhejiang, China, 315010
      • Active, not recruiting
      • Ningbo medical center lihuili hospital
    • Taizhou, Zhejiang, China, 31700
      • Active, not recruiting
      • Taizhou Hospital of Zhejiang Province
• France
  • Brest, France, 29200
    • Active, not recruiting
    • Centre Hospitalier Regional Universitaire (CHRU) Brest
  • Caen, France, 14033
    • Active, not recruiting
    • Centre Hospitalier Universitaire (CHU) de Caen
  • Caen, France, 14059
    • Active, not recruiting
    • Unicancer - Centre François Baclesse (CFB)
  • Créteil, France, 94010
    • Active, not recruiting
    • Centre Hospitalier Intercommunal de Creteil (CHIC
  • Le Mans, France, 72000
    • Active, not recruiting
    • Centre de Cancérologie de la Sarthe
  • Marseille, France, 13915
    • Active, not recruiting
    • Hopital Nord
  • Montpellier, France, 34295
    • Active, not recruiting
    • Centre Hospitalier Universitaire de Montpellier (CHU Montpellier)
  • Paris, France, 75000
    • Active, not recruiting
    • Institut Curie
  • Pierre-Bénite, France, 69495
    • Active, not recruiting
    • Centre hospitalier Lyon-Sud
  • Quimper, France, 29107
    • Active, not recruiting
    • Centre Hospitalier (Intercommunal) De Cornouaille Quimper
  • Rennes, France, 35033
    • Active, not recruiting
    • Centre Hospitalier Universitaire (CHU) de Rennes
  • Saint-Herblain, France, 44805
    • Active, not recruiting
    • Institut de Cancérologie de l'Ouest
  • Strasbourg, France, 67033
    • Active, not recruiting
    • Institut de cancérologie Strasbourg Europe (ICANS)
  • Tours, France, 37044
    • Active, not recruiting
    • Centre Hospitalier Regional et Universitaire de Tours
  • Villejuif, France, 94800
    • Active, not recruiting
    • Gustave Roussy Oncologie Médical
• Germany
  • Esslingen am Neckar, Germany, 73730
    • Active, not recruiting
    • Klinikum Esslingen GmbH
  • Frankfurt, Germany, 60488
    • Active, not recruiting
    • Krankenhaus Nordwest GmbH
  • Gauting, Germany, 82131
    • Active, not recruiting
    • Asklepios Klinik Gauting GmbH
  • Giesen, Germany, 35392
    • Active, not recruiting
    • Universitaetsklinikum Giessen und Marburg
  • Heidelberg, Germany, 69126
    • Active, not recruiting
    • Universitaetsklinikum Heidelberg (UKHD)
  • Jena, Germany, 07747
    • Active, not recruiting
    • Universitaetsklinikum Jena
  • Kempten, Germany, 87435
    • Active, not recruiting
    • Klinikverbund Allgaeu - Klinikum Kempte
  • Lübeck, Germany, 23538
    • Active, not recruiting
    • Universitätsklinikum Schleswig-Holstein
  • Munich, Germany, 81975
    • Active, not recruiting
    • München Klinik gGmbH
• Greece
  • Athens, Greece, 11526
    • Active, not recruiting
    • Henry Dunant Hospital Center
  • Athens, Greece, 11527
    • Active, not recruiting
    • General Hospital of Athens
  • Athens, Greece, 11528
    • Active, not recruiting
    • General Hospital of Athens Alexandra
  • Athens, Greece, 15562
    • Active, not recruiting
    • Metropolitan General Hospital
  • Athens, Greece, 57010
    • Active, not recruiting
    • Interbalkan Medical Center of Thessaloniki
  • Pátrai, Greece, 26443
    • Active, not recruiting
    • Olympion Hospital
  • Pátrai, Greece, 26504
    • Active, not recruiting
    • University General Hospital of Patras
  • Thessaloniki, Greece, 54622
    • Active, not recruiting
    • Galenos General Clinic
  • Thessaloniki, Greece, 57010
    • Active, not recruiting
    • "George Papanikolaou" General Hospital of Thessaloniki
• Ireland
  • Dublin, Ireland, D08 NHY1
    • Active, not recruiting
    • St. James's Hospital (SJH)
  • Dublin, Ireland, D09V2N0
    • Active, not recruiting
    • Beaumont Hospital
  • Galway, Ireland, H91 YR71
    • Active, not recruiting
    • Galway Univeristy Hospitals
• Italy
  • Ancona, Italy, 60126
    • Active, not recruiting
    • Azienda Ospedaliero Universitaria Delle Marche
  • Aviano, Italy, 33081
    • Active, not recruiting
    • Centro di Riferimento Oncologico di Aviano
  • Cremona, Italy, 26100
    • Active, not recruiting
    • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • Genova, Italy, 16149
    • Active, not recruiting
    • Istituto Europeo di Oncologia (IEO)
  • Lucca, Italy, 55100
    • Active, not recruiting
    • Ospedale San Luca
  • Mantua, Italy, 46100
    • Active, not recruiting
    • Azienda Socio Sanitaria Territorilae de Mantova (ASST Mantova)
  • Milan, Italy, 20133
    • Active, not recruiting
    • Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
  • Milan, Italy, 20133
    • Active, not recruiting
    • Istituto Europeo di Oncologia (IEO)
  • Monza, Italy, 20900
    • Active, not recruiting
    • Fondazione IRCCS San Gerardo dei Tintori
  • Naples, Italy, 80131
    • Active, not recruiting
    • Universita degli Studi della Campania "Luigi Vanvitelli"
  • Pavia, Italy, 27100
    • Active, not recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Pesaro, Italy, 61122
    • Active, not recruiting
    • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
  • Peschiera del Garda, Italy, 37019
    • Active, not recruiting
    • Ospedale P. Pederzoli
  • Roma, Italy, 00144
    • Active, not recruiting
    • Istituti Fisioterapici Ospitalieri (IFO)
  • Siena, Italy, 53100
    • Active, not recruiting
    • Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori
  • Verona, Italy, 37134
    • Active, not 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
    • Active, not recruiting
    • Panamerican Clinical Research S.A de C.V.
  • Guadalajara, Mexico, 44680
    • Active, not recruiting
    • Actualidad Basada en Investigación del Cáncer
  • Guadalajara, Mexico, 44680
    • Active, not recruiting
    • Renati Innovation S.A.P.I. DE C.V.
  • La Paz, Mexico, 23040
    • Active, not recruiting
    • Centro de Atención Oncológica Viva
  • Mexico City, Mexico, 03100
    • Active, not recruiting
    • Health Pharma Professional Research S.A. de C.V.
  • Mexico City, Mexico, 03720
    • Active, not recruiting
    • Centro de Investigacion Clinica Gramel
  • Mexico City, Mexico, 06700
    • Active, not recruiting
    • Arké SMO S.A de C.V
  • Mexico City, Mexico, 06760
    • Active, not recruiting
    • Centro de Atención Oncológica Viva
  • Monterrey, Mexico, 64460
    • Active, not recruiting
    • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Monterrey, Mexico, 64060
    • Active, not recruiting
    • Althian Clinical Research
  • Monterrey, Mexico, 64710
    • Active, not recruiting
    • i Can Oncology Center
• Poland
  • Bydgoszcz, Poland, 85796
    • Active, not recruiting
    • Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
  • Lodz, Poland, 90-302
    • Active, not recruiting
    • Instytut Msf Sp. z o.o.
  • Poznan, Poland, 60-693
    • Active, not recruiting
    • Med Polonia Sp. z o.o. NSZOZ
  • Prabuty, Poland, 82-550
    • Active, not recruiting
    • Szpital Specjalistyczny w Prabutach
  • Warsaw, Poland, 04-141
    • Active, not recruiting
    • Wojskowy Instytut Medczny
• Serbia
  • Belgrade, Serbia, 11000
    • Active, not recruiting
    • Acibadem Bel Medic General Hospital
  • Belgrade, Serbia, 11000
    • Active, not recruiting
    • Klinicki Centar Srbije
  • Belgrade, Serbia, 11040
    • Active, not recruiting
    • Vojnomedicinska Akademija (VMA)
  • Belgrade, Serbia, 11080
    • Active, not recruiting
    • Klinicko Bolnicki Centar (KBC) Bezanijska Kosa
  • Kamenica, Serbia, 21204
    • Active, not recruiting
    • Institut Za Plucne Bolesti Vojvodine Klinika za pulmolosku onkologiju
  • Kragujevac, Serbia, 34000
    • Active, not recruiting
    • Univerzitetski Klinicki Centar Kragujevac
  • Niš, Serbia, 18000
    • Active, not recruiting
    • University Clinical Center Nis
• Spain
  • Badajoz, Spain, 06080
    • Active, not recruiting
    • Hospital Universitario de Badajoz
  • Badalona, Spain, 08916
    • Active, not recruiting
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain, 08028
    • Active, not recruiting
    • Hospital Universitari Dexeus
  • Barcelona, Spain, 08003
    • Active, not recruiting
    • Instituto Oncologico Baselga (IOB)
  • Barcelona, Spain, 08025
    • Active, not recruiting
    • Hospital de la Santa Creu i de Sant Pau
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Vall d'Hebron University
  • Barcelona, Spain, 08107
    • Active, not recruiting
    • Mi Tres Torres
  • Girona, Spain, 17007
    • Active, not recruiting
    • Institut d'Investigacio Biomedica de Girona Dr. Josep Trueta
  • Jaén, Spain, 23007
    • Active, not recruiting
    • Hospital Universitario de Jaén
  • Las Palmas de Gran Canaria, Spain, 35016
    • Active, not recruiting
    • Universidad de Las Palmas de Gran Canaria
  • Lugo, Spain, 27003
    • Active, not recruiting
    • Hospital Universitario Lucus Augusti (HULA)
  • Madrid, Spain, 28046
    • Active, not recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Active, not recruiting
    • Universidad Autonoma de Madrid (UAM)
  • Málaga, Spain, 29011
    • Active, not recruiting
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Active, not recruiting
    • Clinica Universidad de Navarra (CUN) - Pamplona
  • Seville, Spain, 41013
    • Active, not recruiting
    • H Universitario Virgen Del Rocio
  • Valencia, Spain, 46010
    • Active, not recruiting
    • Hospital Clinico Universitario de Valencia (CHUV)
  • Valencia, Spain, 46206
    • Active, not recruiting
    • Hospital La Fe Bulevar Sur
  • Vigo, Spain, 36312
    • Active, not recruiting
    • Hospital Alvaro Cunqueiro (HAC)
• Sweden
  • Stockholm, Sweden, 141 86
    • Active, not recruiting
    • Karolinska University Hospital
  • Uppsala, Sweden, 803 24
    • Active, not recruiting
    • Region Gävleborg Gävle Sjukhus Gävle Sjukhus
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • Active, not recruiting
    • SBU Gulhane Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06200
    • Active, not recruiting
    • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research
  • Ankara, Turkey (Türkiye), 06590
    • Active, not recruiting
    • Gazi University Medicine Faculty Hospital
  • Ankara, Turkey (Türkiye), 06620
    • Active, not recruiting
    • Ankara University Medical Oncology
  • Ankara, Turkey (Türkiye), 06620
    • Active, not recruiting
    • Memorial Ankara Hospital
  • Gaziantep, Turkey (Türkiye), 27584
    • Active, not recruiting
    • Medical Point Gaziantep Hospital
  • Istanbul, Turkey (Türkiye), 34098
    • Active, not recruiting
    • İstanbul University Cerrahpasa Medical
  • Istanbul, Turkey (Türkiye), 34180
    • Active, not recruiting
    • Memorial Saglik Grubu Bahçelievler Hospital
  • Istanbul, Turkey (Türkiye), 34460
    • Active, not recruiting
    • Istinye University Bahceshir Liv Hospital
  • Istanbul, Turkey (Türkiye), 34722
    • Active, not recruiting
    • Istanbul Medeniyet University Prof Dr. Suleyman Yalcin City Hospital
  • Izmir, Turkey (Türkiye), 35575
    • Active, not recruiting
    • Izmir Economy University Medical Point İzmir Hospital
  • Kayseri, Turkey (Türkiye), 28039
    • Active, not recruiting
    • Erciyes University Medical Faculty
  • Diyarbakır
    • Sur, Diyarbakır, Turkey (Türkiye), 21280
      • Active, not recruiting
      • Dicle University
  • Kocaeli
    • İzmit, Kocaeli, Turkey (Türkiye), 41380
      • Active, not recruiting
      • Kocaeli University Hospital
  • Konya
    • Meram, Konya, Turkey (Türkiye), 42080
      • Active, not recruiting
      • Necmettin Erbakan University Meram Medical Faculty Hospital
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Active, not recruiting
      • Ege Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • Leeds, United Kingdom, LS2 9JT
    • Active, not recruiting
    • Leeds Teaching Hospitals NHS
  • London, United Kingdom, EC1A 7BE
    • Active, not recruiting
    • St. Bartholomew's Hospital
  • Manchester, United Kingdom, M20 4BX
    • Active, not recruiting
    • The Christie NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Active, not recruiting
      • Banner University Medical Center
    • Tucson, Arizona, United States, 85711
      • Active, not recruiting
      • TMC Healthcare
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Active, not recruiting
      • Genesis Cancer and Blood Institute
    • Little Rock, Arkansas, United States, 72205
      • Active, not recruiting
      • University of Arkansas
  • California
    • Anaheim, California, United States, 92801
      • Active, not recruiting
      • LA Cancer Network
    • Cerritos, California, United States, 90703
      • Active, not recruiting
      • The Oncology Institute of Hope & Innovation
    • Los Angeles, California, United States, 90067
      • Active, not recruiting
      • Valkyrie Clinical Trials
    • Los Angeles, California, United States, 90033
      • Active, not recruiting
      • University of Southern California (USC)
    • Los Angeles, California, United States, 90048
      • Active, not recruiting
      • Cedar Sinai Medical Center
    • Sacramento, California, United States, 95817
      • Active, not recruiting
      • UC Davis Medical Center
    • Sacramento, California, United States, 95816
      • Active, not recruiting
      • Sutter Institute for Medical Research
    • Santa Monica, California, United States, 90404
      • Active, not recruiting
      • University of California Los Angeles (UCLA)
    • Santa Rosa, California, United States, 95403
      • Active, not recruiting
      • Providence Medical Foundation
    • Vallejo, California, United States, 94589
      • Active, not recruiting
      • Kaiser Permanente
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Active, not recruiting
      • Rocky Mountain Cancer
    • Loveland, Colorado, United States, 80538
      • Active, not recruiting
      • Banner MD Anderson Cancer Center at North Colorado Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06053
      • Active, not recruiting
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Active, not recruiting
      • Yale University
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Active, not recruiting
      • Florida Cancer Specialists & Research Institute (FCS)-East
    • Hialeah, Florida, United States, 33013
      • Active, not recruiting
      • BioResearch Partner- Hialeah Hospital
    • Hollywood, Florida, United States, 33021
      • Active, not recruiting
      • Memorial Healthcare System
    • Jacksonville, Florida, United States, 32224
      • Active, not recruiting
      • Mayo Clinic
    • Jacksonville, Florida, United States, 32256
      • Active, not recruiting
      • Cancer Specialists of North Florida
    • Ocala, Florida, United States, 34474
      • Active, not recruiting
      • Ocala Oncology
    • Palm Bay, Florida, United States, 32901
      • Active, not recruiting
      • Cancer Care of Brevard
    • Pensacola, Florida, United States, 32504
      • Active, not recruiting
      • Ascension Sacred Heart Health System
    • Petersburg, Florida, United States, 33709
      • Active, not recruiting
      • Exigent Network
    • Plantation, Florida, United States, 33322
      • Active, not recruiting
      • BRCR Medical Center Inc
    • St. Petersburg, Florida, United States, 33705
      • Active, not recruiting
      • Florida Cancer Specialists & Research Institute (FCS) - North
    • Tamarac, Florida, United States, 33321
      • Active, not recruiting
      • BRCR Medical Center Inc.
    • West Palm Beach, Florida, United States, 33401
      • Active, not recruiting
      • Florida Cancer Specialists & Research Institute (FCS)-South
  • Georgia
    • Macon, Georgia, United States, 31210
      • Active, not recruiting
      • Central Georgia Cancer Care
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Active, not recruiting
      • Northwestern Memorial Hospital
    • Peoria, Illinois, United States, 61615
      • Active, not recruiting
      • Illinois Cancer Care P.C.
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Active, not recruiting
      • University of Kansas Cancer Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Active, not recruiting
      • Baptist Health
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Active, not recruiting
      • Ascension Saint Agnes Hospital
    • Baltimore, Maryland, United States, 21187
      • Active, not recruiting
      • Sidney Kimmel Comprehensive Cancer Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Active, not recruiting
      • Lahey Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Active, not recruiting
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Active, not recruiting
      • Trinity Health
    • Detroit, Michigan, United States, 48202
      • Active, not recruiting
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Active, not recruiting
      • Karmanos Cancer Insitute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Active, not recruiting
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55101
      • Active, not recruiting
      • Park Nicollet Institute
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Active, not recruiting
      • American Oncology Partners, PA
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University St.Louis
  • Montana
    • Billings, Montana, United States, 59102
      • Active, not recruiting
      • St. Vincent Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Active, not recruiting
      • University of Nebraska Medical Center (UNMC)
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Active, not recruiting
      • Dartmouth-Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Memorial Sloan Kettering
    • New York, New York, United States, 10029
      • Active, not recruiting
      • Mount Sinai
    • Syracuse, New York, United States, 13210
      • Active, not recruiting
      • SUNY Upstate Medical University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Active, not recruiting
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Active, not recruiting
      • Levine Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Active, not recruiting
      • Oncology Hematology Care (OHC), Inc
    • Cleveland, Ohio, United States, 44195
      • Active, not recruiting
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Active, not recruiting
      • University Hospitals Case Medical Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Active, not recruiting
      • Willamette Valley Cancer Institute and Research Center (WVCI)
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Active, not recruiting
      • Medical University of South Carolina (MUSC)
    • Greenville, South Carolina, United States, 29605
      • Active, not recruiting
      • Prisma Health-Upstate
  • Tennessee
    • Memphis, Tennessee, United States, 38138
      • Active, not recruiting
      • West Cancer Center
    • Nashville, Tennessee, United States, 37203
      • Active, not recruiting
      • SCRI-Nashville
  • Texas
    • Austin, Texas, United States, 78745
      • Active, not recruiting
      • Texas Oncology- Austin
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75246
      • Active, not recruiting
      • Texas Oncology-Dallas
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • Houston Methodist Hospital
    • San Antonio, Texas, United States, 78216
      • Active, not recruiting
      • Texas Oncology-San Antonio
    • Tyler, Texas, United States, 75702
      • Active, not recruiting
      • Texas Oncology-Tyler
    • Tyler, Texas, United States, 75708
      • Active, not recruiting
      • University of Texas at Tyler
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Active, not recruiting
      • Virginia Oncology Associates
    • Reston, Virginia, United States, 20190
      • Active, not recruiting
      • Virginia Cancer
  • Washington
    • Seattle, Washington, United States, 98103
      • Active, not recruiting
      • Swedish Cancer Institute
    • Spokane, Washington, United States, 99202
      • Active, not recruiting
      • Cancer Care NW Centers
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Active, not 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): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 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