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)
1 other identifier
interventional
1,600
16 countries
246
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Oct 2023
Typical duration for phase_3 nonsmall-cell-lung-cancer
246 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedStudy Start
First participant enrolled
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
April 30, 2026
January 1, 2026
5.2 years
June 1, 2023
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Adverse Event (AE)
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.
Study Arms (2)
Arm A - Ivonescimab and chemotherapy
EXPERIMENTALSubject will receive ivonescimab and chemotherapy
Arm B - Pembrolizumab and chemotherapy
ACTIVE COMPARATORSubject will receive pembrolizumab and chemotherapy
Interventions
Subject will receive ivonescimab and chemotherapy as an IV injection
Subject will receive pembrolizumab and chemotherapy as an IV injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (253)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Indu Lal
Summit Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 12, 2023
Study Start
October 26, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
April 30, 2026
Record last verified: 2026-01