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

NCT05899608 · Summit Therapeutics
In plain English

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Official title
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)
About this study
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
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 design
Enrollment target: 1600 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-10-26
Estimated completion: 2029-12-31
Last updated: 2026-01-07
Interventions
Biological: Ivonescimab InjectionBiological: Pembrolizumab Injection
Primary outcomes
  • Overall Survival (OS) (approximately 4 years)
  • Progression Free Survival (PFS) (approximately 3 years)
Sponsor
Summit Therapeutics · industry
Contacts & investigators
ContactSummit Clinical Trial Information · contact · medicalinformation@smmttx.com · 1-833-256-0522
InvestigatorIndu Lal · study_director, Summit Therapeutics, Inc.
All locations (244)
Banner University Medical CenterRecruiting
Phoenix, Arizona, United States
TMC HealthcareRecruiting
Tucson, Arizona, United States
University of ArkansasRecruiting
Little Rock, Arkansas, United States
LA Cancer NetworkRecruiting
Anaheim, California, United States
The Oncology Institute of Hope & InnovationRecruiting
Cerritos, California, United States
University of Southern California (USC)Recruiting
Los Angeles, California, United States
Cedar Sinai Medical CenterRecruiting
Los Angeles, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
Sutter Institute for Medical ResearchRecruiting
Sacramento, California, United States
UC Davis Medical CenterRecruiting
Sacramento, California, United States
University of California Los Angeles (UCLA)Recruiting
Santa Monica, California, United States
Providence Medical FoundationRecruiting
Santa Rosa, California, United States
Kaiser PermanenteRecruiting
Vallejo, California, United States
Rocky Mountain CancerRecruiting
Lone Tree, Colorado, United States
Banner MD Anderson Cancer Center at North Colorado Medical CenterRecruiting
Loveland, Colorado, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute (FCS)-EastRecruiting
Fort Myers, Florida, United States
BioResearch Partner- Hialeah HospitalRecruiting
Hialeah, Florida, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
Cancer Specialists of North FloridaRecruiting
Jacksonville, Florida, United States
Ocala OncologyRecruiting
Ocala, Florida, United States
Cancer Care of BrevardRecruiting
Palm Bay, Florida, United States
Memorial Cancer InstituteRecruiting
Pembroke Pines, Florida, United States
Ascension Sacred Heart Health SystemRecruiting
Pensacola, Florida, United States
Exigent NetworkRecruiting
Petersburg, Florida, United States
BRCR Medical Center IncRecruiting
Plantation, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - NorthRecruiting
St. Petersburg, Florida, United States
BRCR Medical Center Inc.Recruiting
Tamarac, Florida, United States
Florida Cancer Specialists & Research Institute (FCS)-SouthRecruiting
West Palm Beach, Florida, United States
Illinois Cancer CareRecruiting
Peoria, Illinois, United States
University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Baptist HealthRecruiting
Lexington, Kentucky, United States
Sidney Kimmel Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Ascension Saint Agnes HospitalRecruiting
Baltimore, Maryland, United States
Lahey HospitalRecruiting
Burlington, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Trinity HealthRecruiting
Ann Arbor, Michigan, United States
Karmanos Cancer InsituteRecruiting
Detroit, Michigan, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Park Nicollet InstituteRecruiting
Saint Paul, Minnesota, United States
American Oncology Partners, PARecruiting
Kansas City, Missouri, United States
Washington University St.LouisRecruiting
St Louis, Missouri, United States
St. Vincent Cancer CenterRecruiting
Billings, Montana, United States
University of Nebraska Medical Center (UNMC)Recruiting
Omaha, Nebraska, United States
Mount SinaiRecruiting
New York, New York, United States
Memorial Sloan KetteringRecruiting
New York, New York, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Levine CenterRecruiting
Charlotte, North Carolina, United States
Oncology Hematology Care (OHC), IncRecruiting
Cincinnati, Ohio, United States
University Hospitals Case Medical CenterRecruiting
Cleveland, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Willamette Valley Cancer Institute and Research Center (WVCI)Recruiting
Eugene, Oregon, United States
Medical University of South Carolina (MUSC)Recruiting
Charleston, South Carolina, United States
Prisma Health-UpstateRecruiting
Greenville, South Carolina, United States
West Cancer CenterRecruiting
Memphis, Tennessee, United States
SCRI-NashvilleRecruiting
Nashville, Tennessee, United States
Texas Oncology- AustinRecruiting
Austin, Texas, United States
Texas Oncology-DallasRecruiting
Dallas, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Houston Methodist HospitalRecruiting
Houston, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Oncology-San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology-TylerRecruiting
Tyler, Texas, United States
University of Texas at TylerRecruiting
Tyler, Texas, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Virginia CancerRecruiting
Reston, Virginia, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Cancer Care NW CentersRecruiting
Spokane, Washington, United States
Carbone Cancer CenterRecruiting
Madison, Wisconsin, United States
CHU UC Louvain NamurRecruiting
Louvain-la-Neuve, Belgium
az GlorieuxRecruiting
Ronse, Belgium
London Regional (LRCP)Recruiting
London, Ontario, Canada
Ottawa Cancer CenterRecruiting
Ottawa, Ontario, Canada
Saskatchewan CancerRecruiting
Regina, Saskatchewan, Canada
Fu Yang People's HospitalRecruiting
Yangzhou, Anhui, China
Beijing Chest HospitalRecruiting
Tongzhou, Beijing Municipality, China
Fujian Cancer HospitalRecruiting
Fuzhou, Fujian, China
Gansu Provincial Cancer HospitalRecruiting
Lanzhou, Gansu, China
Fujian Cancer HospitalRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
Nanning, Guangxi, China
Hainan General HospitalRecruiting
Haikou, Hainan, China
The Fourth Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, Hebei, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
Henan University of Science and Technology Affiliated Anyang Cancer HospitalRecruiting
Anyang, Henan, China
Nanyang Central HospitalRecruiting
Nanyang, Henan, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
Henan University of Science and Technology Affiliated Anyang Cancer HospitalRecruiting
Zhengzhou, Henan, China
The First Affiliated Hospital of Yangtze UniversityRecruiting
Jingzhou, Hubei, China
Xiangyang Central HospitalRecruiting
Xiangyang, Hubei, China
Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
Hunan Cancer Hospital Thoracic Medicine 1Recruiting
Changsha, Hunan, China
The First Affiliated Hospital Of University Of South ChinaRecruiting
Hengyang, Hunan, China
The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Xuzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical UniversityRecruiting
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
Jiangxi Cancer HospitalRecruiting
Nanchang, Jiangxi, China
Shengjing Hospital Of China Medical UniversityRecruiting
Shenyang, Liaoning, China
The Second Affiliated Hospital of AFMURecruiting
Xi'an, Shaanxi, China
The first affiliated Hospital of xi'an jiao tong universityRecruiting
Xi'an, Shaanxi, China
Shandong Cancer HospitalRecruiting
Jinan, Shandong, China
Linyi People's HospitalRecruiting
Linyi, Shandong, China
Qingdao Central HospitalRecruiting
Qingdao, Shandong, China
Fudan University Shanghai Cancer CenterRecruiting
Xuhui, Shanghai Municipality, China
Shanghai Chest HospitalRecruiting
Xuhui, Shanghai Municipality, China
Shanghai Pulmonary HospitalRecruiting
Yangpu, Shanghai Municipality, China
Shanxi Provincial Cancer HospitalRecruiting
Taiyuan, Shanxi, China
Mianyang Central HospitalRecruiting
Mianyang, Sichuan, China
Cancer Hospital Affiliated to Xinjiang Medical UniversityRecruiting
Ürümqi, Xinjiang, China
Yunnan Cancer HospitalRecruiting
Kunming, Yunnan, China
The First Affiliated Hospital,Zhejiang UniversityRecruiting
Hanzhou, Zhejiang, China
Zhejiang Cancer HospitalRecruiting
Hanzhou, Zhejiang, China
Jinhua Municipal Central HospitalRecruiting
Jinhua, Zhejiang, China
Ningbo Medical Center Lihuili HospitalRecruiting
Ningbo, Zhejiang, China
TaiZhou Hospital Of Zhejiang ProvinceRecruiting
Taizhou, Zhejiang, China
Cancer Hospital Chinese Academy of Medical ScienceRecruiting
Beijing, China
Peking University People's HospitalRecruiting
Beijing, China
The Fifth Medical Center of the General Hospital of the Chinese People's Liberation ArmyRecruiting
Beijing, China
Hunan Cancer Hospital Thoracic Medicine 2Recruiting
Changsha, China
Guangxi Medical University Cancer HospitalRecruiting
Guangxi, China
Centre Hospitalier Regional Universitaire (CHRU) BrestRecruiting
Brest, France
Centre Hospitalier Universitaire (CHU) de CaenRecruiting
Caen, France
Unicancer - Centre François Baclesse (CFB)Recruiting
Caen, France
Centre Hospitalier Intercommunal de Creteil (CHICRecruiting
Créteil, France
Centre de Cancérologie de la SartheRecruiting
Le Mans, France
Hopital NordRecruiting
Marseille, France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier)Recruiting
Montpellier, France
Institut CurieRecruiting
Paris, France
Centre Hospitalier Lyon-SudRecruiting
Pierre-Bénite, France
Centre Hospitalier (Intercommunal) De Cornouaille QuimperRecruiting
Quimper, France
Centre Hospitalier Universitaire (CHU) de RennesRecruiting
Rennes, France
Institut de Cancérologie de l'OuestRecruiting
Saint-Herblain, France
Institut de cancérologie Strasbourg Europe (ICANS)Recruiting
Strasbourg, France
Centre Hospitalier Regional et Universitaire de ToursRecruiting
Tours, France
Gustave Roussy Oncologie MédicalRecruiting
Villejuif, France
Klinikum Esslingen GmbHRecruiting
Esslingen am Neckar, Germany
Krankenhaus Nordwest GmbHRecruiting
Frankfurt, Germany
Asklepios Klinik Gauting GmbHRecruiting
Gauting, Germany
Universitaetsklinikum Giessen und MarburgRecruiting
Giesen, Germany
Universitaetsklinikum Heidelberg (UKHD)Recruiting
Heidelberg, Germany
Universitaetsklinikum JenaRecruiting
Jena, Germany
Klinikverbund Allgaeu - Klinikum KempteRecruiting
Kempten, Germany
Universitätsklinikum Schleswig-HolsteinRecruiting
Lübeck, Germany
München Klinik gGmbHRecruiting
Munich, Germany
Henry Dunant Hospital CenterRecruiting
Athens, Greece
General Hospital of AthensRecruiting
Athens, Greece
General Hospital of Athens AlexandraRecruiting
Athens, Greece
Metropolitan General HospitalRecruiting
Athens, Greece
Interbalkan Medical Center of ThessalonikiRecruiting
Athens, Greece
Olympion HospitalRecruiting
Pátrai, Greece
University General Hospital of PatrasRecruiting
Pátrai, Greece
Galenos General ClinicRecruiting
Thessaloniki, Greece
"George Papanikolaou" General Hospital of ThessalonikiRecruiting
Thessaloniki, Greece
St. James's Hospital (SJH)Recruiting
Dublin, Ireland
Beaumont HospitalRecruiting
Dublin, Ireland
Galway Univeristy HospitalsRecruiting
Galway, Ireland
Azienda Ospedaliero Universitaria delle MarcheRecruiting
Ancona, Italy
Centro di Riferimento Oncologico di AvianoRecruiting
Aviano, Italy
Azienda Ospedaliera "Istituti Ospitalieri" di CremonaRecruiting
Cremona, Italy
Istituto Europeo di Oncologia (IEO)Recruiting
Genova, Italy
Ospedale San LucaRecruiting
Lucca, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori - MilanoRecruiting
Milan, Italy
Istituto Europeo di Oncologia (IEO)Recruiting
Milan, Italy
Fondazione IRCCS San Gerardo dei TintoriRecruiting
Monza, Italy
Universita degli Studi della Campania "Luigi Vanvitelli"Recruiting
Naples, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)Recruiting
Pesaro, Italy
Ospedale P. PederzoliRecruiting
Peschiera del Garda, Italy
Istituti Fisioterapici Ospitalieri (IFO)Recruiting
Roma, Italy
Azienda Ospedaliera Universitaria Senese - Istituto Toscano TumoriRecruiting
Siena, Italy
Ospedale G.B. Rossi Borgo RomaRecruiting
Verona, Italy
Fujita Health University HospitalRecruiting
Aichi, Japan
National Hospital Organization Kyusyu Medical CenterRecruiting
Fukuoka, Japan
Hirosaki University HospitalRecruiting
Hirosaki, Japan
Hiroshima University HospitalRecruiting
Hiroshima, Japan
National Hospital Organization - Hokkaido Cancer CenterRecruiting
Hokkaido, Japan
Hakodate Goryoukaku HospitalRecruiting
Hokkaido, Japan
Nara Medical University HospitalRecruiting
Kashihara, Japan
Shinshu University HospitalRecruiting
Matsumoto, Japan
Sendai Kousei HospitalRecruiting
Miyagi, Japan
Okayama University HospitalRecruiting
Okayama, Japan
Osaka Medical and Pharmaceutical University Hospital (OMPU Hp)Recruiting
Osaka, Japan
Kansai Medical University HospitalRecruiting
Osaka, Japan
Shizuoka Cancer Center (SCC)Recruiting
Shizuoka, Japan
National Cancer Center Hospital (NCCH)Recruiting
Tokyo, Japan
The Cancer institute HospitalRecruiting
Tokyo, Japan
National Hospital Organization Yamaguchi Ube Medical CenterRecruiting
Yamaguchi, Japan
Kanagawa Cancer CenterRecruiting
Yokohama, Japan
Tottori University HospitalRecruiting
Yonago, Japan
Panamerican Clinical Research S.A de C.V.Recruiting
Guadalajara, Mexico
Actualidad Basada en Investigación del CáncerRecruiting
Guadalajara, Mexico
Renati Innovation S.A.P.I. DE C.V.Recruiting
Guadalajara, Mexico
Centro de Atención Oncológica VivaRecruiting
La Paz, Mexico
Health Pharma Professional Research S.A. de C.V.Recruiting
Mexico City, Mexico
Centro de Investigación Clínica GRAMELRecruiting
Mexico City, Mexico
Arke SMO S.A DE C.VRecruiting
Mexico City, Mexico
Centro de Atención Oncológica VivaRecruiting
Mexico City, Mexico
Althian Clinical ResearchRecruiting
Monterrey, Mexico
CRI Centro Regiomontano de Investigación S.C.Recruiting
Monterrey, Mexico
Hospital Universitario "Dr. José Eleuterio González"Recruiting
Monterrey, Mexico
I Can Oncology CenterRecruiting
Monterrey, Mexico
Centrum Onkologii im. prof. F. Lukaszczyka w BydgoszczyRecruiting
Bydgoszcz, Poland
Instytut Msf Sp. z o.o.Recruiting
Lodz, Poland
Med Polonia Sp. z o.o. NSZOZRecruiting
Poznan, Poland
Szpital Specjalistyczny w PrabutachRecruiting
Prabuty, Poland
Wojskowy Instytut MedcznyRecruiting
Warsaw, Poland
Acibadem Bel Medic General HospitalRecruiting
Belgrade, Serbia
Klinicki Centar SrbijeRecruiting
Belgrade, Serbia
Vojnomedicinska Akademija (VMA)Recruiting
Belgrade, Serbia
Klinicko Bolnicki Centar (KBC) Bezanijska KosaRecruiting
Belgrade, Serbia
Institut Za Plucne Bolesti Vojvodine Klinika za pulmolosku onkologijuRecruiting
Kamenica, Serbia
Univerzitetski Klinicki Centar KragujevacRecruiting
Kragujevac, Serbia
University Clinical Center NišRecruiting
Niš, Serbia
Hospital Universitario de BadajozRecruiting
Badajoz, Spain
Hospital Universitari Germans Trias i PujolRecruiting
Badalona, Spain
Instituto Oncologico Baselga (IOB)Recruiting
Barcelona, Spain
Hospital de la Santa Creu i de Sant PauRecruiting
Barcelona, Spain
Hospital Universitari DexeusRecruiting
Barcelona, Spain
Vall d'Hebron UniversityRecruiting
Barcelona, Spain
Mi Tres TorresRecruiting
Barcelona, Spain
Institut d'Investigacio Biomedica de Girona Dr. Josep TruetaRecruiting
Girona, Spain
Hospital Universitario de JaénRecruiting
Jaén, Spain
Universidad de Las Palmas de Gran CanariaRecruiting
Las Palmas de Gran Canaria, Spain
Hospital Universitario Lucus Augusti (HULA)Recruiting
Lugo, Spain
Universidad Autonoma de Madrid (UAM)Recruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Regional Universitario de MálagaRecruiting
Málaga, Spain
Clinica Universidad de Navarra (CUN) - PamplonaRecruiting
Pamplona, Spain
H Universitario Virgen Del RocioRecruiting
Seville, Spain
Hospital Clinico Universitario de Valencia (CHUV)Recruiting
Valencia, Spain
Hospital La Fe Bulevar SurRecruiting
Valencia, Spain
Hospital Alvaro Cunqueiro (HAC)Recruiting
Vigo, Spain
Karolinska University HospitalRecruiting
Stockholm, Sweden
Region Gävleborg Gävle Sjukhus Gävle SjukhusRecruiting
Uppsala, Sweden
Memorial Ankara HospitalRecruiting
Ankara, Turkey (Türkiye)
Dicle UniversityRecruiting
Diyarbakır, Turkey (Türkiye)
Memorial Saglik Grubu Bahçelievler HospitalRecruiting
Istanbul, Turkey (Türkiye)
Istinye University Bahceshir Liv HospitalRecruiting
Istanbul, Turkey (Türkiye)
Kocaeli University HospitalRecruiting
İzmit, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty HospitalRecruiting
Konya, Turkey (Türkiye)
Leeds Teaching Hospitals NHSRecruiting
Leeds, United Kingdom
St. Bartholomew's hospitalRecruiting
London, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients · TrialPath