AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT05899608

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

A Phase 3 study testing Ivonescimab Injection and Pembrolizumab Injection in people with Non-Small Cell Lung Cancer, run by Summit Therapeutics at 260 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Ivonescimab Injection and Pembrolizumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
260 sitesin 17 countries
Study dates
26 Oct 2023to 31 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

260 sites in 17 countries.

260 sites in 17 countries

United States76 sites

  • LA Cancer Network

    Anaheim, California, 92801

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Trinity Health

    Ann Arbor, Michigan, 48197

  • Texas Oncology- Austin

    Austin, Texas, 78745

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21187

  • Ascension Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • St. Vincent Cancer Center

    Billings, Montana, 59102

  • Lahey Hospital

    Burlington, Massachusetts, 01805

  • The Oncology Institute of Hope & Innovation

    Cerritos, California, 90703

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Levine Center

    Charlotte, North Carolina, 28204

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Oncology Hematology Care (OHC), Inc

    Cincinnati, Ohio, 45242

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Texas Oncology-Dallas

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Insitute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Willamette Valley Cancer Institute and Research Center (WVCI)

    Eugene, Oregon, 97401

  • Florida Cancer Specialists & Research Institute (FCS)-East

    Fort Myers, Florida, 33901

  • Prisma Health-Upstate

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06053

  • BioResearch Partner- Hialeah Hospital

    Hialeah, Florida, 33013

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Genesis Cancer and Blood Institute

    Hot Springs, Arkansas, 71913

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • American Oncology Partners, PA

    Kansas City, Missouri, 64132

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health

    Lexington, Kentucky, 40503

  • University of Arkansas

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer

    Lone Tree, Colorado, 80124

  • University of Southern California (USC)

    Los Angeles, California, 90033

  • Cedar Sinai Medical Center

    Los Angeles, California, 90048

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Banner MD Anderson Cancer Center at North Colorado Medical Center

    Loveland, Colorado, 80538

  • Central Georgia Cancer Care

    Macon, Georgia, 31210

  • Carbone Cancer Center

    Madison, Wisconsin, 53792

  • West Cancer Center

    Memphis, Tennessee, 38138

  • SCRI-Nashville

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06510

  • Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology

    Ocala, Florida, 34474

  • University of Nebraska Medical Center (UNMC)

    Omaha, Nebraska, 68105

  • Cancer Care of Brevard

    Palm Bay, Florida, 32901

  • Ascension Sacred Heart Health System

    Pensacola, Florida, 32504

  • Illinois Cancer Care P.C.

    Peoria, Illinois, 61615

  • Exigent Network

    Petersburg, Florida, 33709

  • Banner University Medical Center

    Phoenix, Arizona, 85006

  • BRCR Medical Center Inc

    Plantation, Florida, 33322

  • Virginia Cancer

    Reston, Virginia, 20190

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Park Nicollet Institute

    Saint Paul, Minnesota, 55101

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78216

  • University of California Los Angeles (UCLA)

    Santa Monica, California, 90404

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Swedish Cancer Institute

    Seattle, Washington, 98103

  • Cancer Care NW Centers

    Spokane, Washington, 99202

  • Washington University St.Louis

    St Louis, Missouri, 63110

  • Florida Cancer Specialists & Research Institute (FCS) - North

    St. Petersburg, Florida, 33705

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • BRCR Medical Center Inc.

    Tamarac, Florida, 33321

  • TMC Healthcare

    Tucson, Arizona, 85711

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • University of Texas at Tyler

    Tyler, Texas, 75708

  • Kaiser Permanente

    Vallejo, California, 94589

  • Florida Cancer Specialists & Research Institute (FCS)-South

    West Palm Beach, Florida, 33401

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

China46 sites

  • Henan University of Science and Technology Affiliated Anyang Cancer Hospital

    Anyang, Henan, 471023

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, 100021

  • Peking University People's Hospital

    Beijing, 100044

  • The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army

    Beijing, 100853

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Hunan Cancer Hospital Thoracic Medicine 1

    Changsha, Hunan, 410013

  • Hunan Cancer Hospital Thoracic Medicine 2

    Changsha, 410013

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Guangxi Medical University Cancer Hospital

    Guangxi, 530021

  • Fujian Cancer Hospital

    Guangzhou, Guangdong, 510230

  • Hainan General Hospital

    Haikou, Hainan, 190000

  • The First Affiliated Hospital,Zhejiang University

    Hanzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hanzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital Of University Of South China

    Hengyang, Hunan, 421001

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • The First Affiliated Hospital of Yangtze University

    Jingzhou, Hubei, 434023

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730013

  • Linyi People's Hospital

    Linyi, Shandong, 276001

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621099

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330209

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

  • Nanyang Central Hospital

    Nanyang, Henan, 473001

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315010

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

  • Shengjing Hospital Of China Medical University

    Shenyang, Liaoning, 110004

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • TaiZhou Hospital Of Zhejiang Province

    Taizhou, Zhejiang, 31700

  • Beijing Chest Hospital

    Tongzhou, Beijing Municipality, 101125

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • The Second Affiliated Hospital of AFMU

    Xi'an, Shaanxi, 710004

  • The first affiliated Hospital of xi'an jiao tong university

    Xi'an, Shaanxi, 710049

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441100

  • Fudan University Shanghai Cancer Center

    Xuhui, Shanghai Municipality, 200032

  • Shanghai Chest Hospital

    Xuhui, Shanghai Municipality, 200940

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 2210000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

  • Shanghai Pulmonary Hospital

    Yangpu, Shanghai Municipality, 200433

  • Fu Yang People's Hospital

    Yangzhou, Anhui, 236010

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Zhejiang, 310009

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

Spain19 sites

  • Hospital Universitario de Badajoz

    Badajoz, 06080

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Instituto Oncologico Baselga (IOB)

    Barcelona, 08003

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08025

  • Hospital Universitari Dexeus

    Barcelona, 08028

  • Vall d'Hebron University

    Barcelona, 08035

  • Mi Tres Torres

    Barcelona, 08107

  • Institut d'Investigacio Biomedica de Girona Dr. Josep Trueta

    Girona, 17007

  • Hospital Universitario de Jaén

    Jaén, 23007

  • Universidad de Las Palmas de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Lucus Augusti (HULA)

    Lugo, 27003

  • Universidad Autonoma de Madrid (UAM)

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29011

  • Clinica Universidad de Navarra (CUN) - Pamplona

    Pamplona, 31008

  • H Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia (CHUV)

    Valencia, 46010

  • Hospital La Fe Bulevar Sur

    Valencia, 46206

  • Hospital Alvaro Cunqueiro (HAC)

    Vigo, 36312

Other trials in Spain

Japan18 sites

  • Fujita Health University Hospital

    Aichi, 470-1192

  • National Hospital Organization Kyusyu Medical Center

    Fukuoka, 810-8563

  • Hirosaki University Hospital

    Hirosaki, 036-8563

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Hospital Organization - Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Hakodate Goryoukaku Hospital

    Hokkaido, 040-8611

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Shinshu University Hospital

    Matsumoto, 390-8621

  • Sendai Kousei Hospital

    Miyagi, 981-0914

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka Medical and Pharmaceutical University Hospital (OMPU Hp)

    Osaka, 569-8686

  • Kansai Medical University Hospital

    Osaka, 573-1191

  • Shizuoka Cancer Center (SCC)

    Shizuoka, 411-8777

  • National Cancer Center Hospital (NCCH)

    Tokyo, 104-0045

  • The Cancer institute Hospital of JFCR

    Tokyo, 135-8550

  • National Hospital Organization Yamaguchi Ube Medical Center

    Yamaguchi, 755-0241

  • Kanagawa Cancer Center

    Yokohama, 241-8515

  • Tottori University Hospital

    Yonago, 683-8504

Other trials in Japan

Italy16 sites

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60126

  • Centro di Riferimento Oncologico di Aviano

    Aviano, 33081

  • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

    Cremona, 26100

  • Istituto Europeo di Oncologia (IEO)

    Genova, 16149

  • Ospedale San Luca

    Lucca, 55100

  • Azienda Socio Sanitaria Territorilae de Mantova (ASST Mantova)

    Mantua, 46100

  • Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano

    Milan, 20133

  • Istituto Europeo di Oncologia (IEO)

    Milan, 20133

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

  • Universita degli Studi della Campania "Luigi Vanvitelli"

    Naples, 80131

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)

    Pesaro, 61122

  • Ospedale P. Pederzoli

    Peschiera del Garda, 37019

  • Istituti Fisioterapici Ospitalieri (IFO)

    Roma, 00144

  • Azienda Ospedaliera Universitaria Senese - Istituto Toscano Tumori

    Siena, 53100

  • Ospedale G.B. Rossi Borgo Roma

    Verona, 37134

Other trials in Italy

Turkey (Türkiye)16 sites

  • SBU Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research

    Ankara, 06200

  • Gazi University Medicine Faculty Hospital

    Ankara, 06590

  • Ankara University Medical Oncology

    Ankara, 06620

  • Memorial Ankara Hospital

    Ankara, 06620

  • Ege Universitesi Tip Fakultesi Hastanesi

    Bornova, İzmir, 35100

  • Medical Point Gaziantep Hospital

    Gaziantep, 27584

  • İstanbul University Cerrahpasa Medical

    Istanbul, 34098

  • Memorial Saglik Grubu Bahçelievler Hospital

    Istanbul, 34180

  • Istinye University Bahceshir Liv Hospital

    Istanbul, 34460

  • Istanbul Medeniyet University Prof Dr. Suleyman Yalcin City Hospital

    Istanbul, 34722

  • Izmir Economy University Medical Point İzmir Hospital

    Izmir, 35575

  • Kocaeli University Hospital

    İzmit, Kocaeli, 41380

  • Erciyes University Medical Faculty

    Kayseri, 28039

  • Necmettin Erbakan University Meram Medical Faculty Hospital

    Meram, Konya, 42080

  • Dicle University

    Sur, Diyarbakır, 21280

Other trials in Turkey (Türkiye)

France15 sites

  • Centre Hospitalier Regional Universitaire (CHRU) Brest

    Brest, 29200

  • Centre Hospitalier Universitaire (CHU) de Caen

    Caen, 14033

  • Unicancer - Centre François Baclesse (CFB)

    Caen, 14059

  • Centre Hospitalier Intercommunal de Creteil (CHIC

    Créteil, 94010

  • Centre de Cancérologie de la Sarthe

    Le Mans, 72000

  • Hopital Nord

    Marseille, 13915

  • Centre Hospitalier Universitaire de Montpellier (CHU Montpellier)

    Montpellier, 34295

  • Institut Curie

    Paris, 75000

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier (Intercommunal) De Cornouaille Quimper

    Quimper, 29107

  • Centre Hospitalier Universitaire (CHU) de Rennes

    Rennes, 35033

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67033

  • Centre Hospitalier Regional et Universitaire de Tours

    Tours, 37044

  • Gustave Roussy Oncologie Médical

    Villejuif, 94800

Other trials in France

Mexico11 sites

  • Panamerican Clinical Research S.A de C.V.

    Guadalajara, 44670

  • Actualidad Basada en Investigación del Cáncer

    Guadalajara, 44680

  • Renati Innovation S.A.P.I. DE C.V.

    Guadalajara, 44680

  • Centro de Atención Oncológica Viva

    La Paz, 23040

  • Health Pharma Professional Research S.A. de C.V.

    Mexico City, 03100

  • Centro de Investigación Clínica GRAMEL

    Mexico City, 03720

  • Arke SMO S.A DE C.V

    Mexico City, 06700

  • Centro de Atención Oncológica Viva

    Mexico City, 06760

  • Althian Clinical Research

    Monterrey, 64060

  • Hospital Universitario "Dr. José Eleuterio González"

    Monterrey, 64460

  • I Can Oncology Center

    Monterrey, 64710

Other trials in Mexico

Germany9 sites

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488

  • Asklepios Klinik Gauting GmbH

    Gauting, 82131

  • Universitaetsklinikum Giessen und Marburg

    Giesen, 35392

  • Universitaetsklinikum Heidelberg (UKHD)

    Heidelberg, 69126

  • Universitaetsklinikum Jena

    Jena, 07747

  • Klinikverbund Allgaeu - Klinikum Kempte

    Kempten, 87435

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • München Klinik gGmbH

    Munich, 81975

Other trials in Germany

Greece9 sites

  • Henry Dunant Hospital Center

    Athens, 11526

  • General Hospital of Athens

    Athens, 11527

  • General Hospital of Athens Alexandra

    Athens, 11528

  • Metropolitan General Hospital

    Athens, 15562

  • Interbalkan Medical Center of Thessaloniki

    Athens, 57010

  • Olympion Hospital

    Pátrai, 26443

  • University General Hospital of Patras

    Pátrai, 26504

  • Galenos General Clinic

    Thessaloniki, 54622

  • "George Papanikolaou" General Hospital of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

Serbia7 sites

  • Acibadem Bel Medic General Hospital

    Belgrade, 11000

  • Klinicki Centar Srbije

    Belgrade, 11000

  • Vojnomedicinska Akademija (VMA)

    Belgrade, 11040

  • Klinicko Bolnicki Centar (KBC) Bezanijska Kosa

    Belgrade, 11080

  • Institut Za Plucne Bolesti Vojvodine Klinika za pulmolosku onkologiju

    Kamenica, 21204

  • Univerzitetski Klinicki Centar Kragujevac

    Kragujevac, 34000

  • University Clinical Center Niš

    Niš, 18000

Other trials in Serbia

Poland5 sites

  • Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85796

  • Instytut Msf Sp. z o.o.

    Lodz, 90-302

  • Med Polonia Sp. z o.o. NSZOZ

    Poznan, 60-693

  • Szpital Specjalistyczny w Prabutach

    Prabuty, 82-550

  • Wojskowy Instytut Medczny

    Warsaw, 04-141

Other trials in Poland

Canada3 sites

  • London Regional (LRCP)

    London, Ontario, N6A5W9

  • Ottawa Cancer Center

    Ottawa, Ontario, K1H8L6

  • Saskatchewan Cancer

    Regina, Saskatchewan, S4T7T1

Other trials in Canada

Ireland3 sites

  • St. James's Hospital (SJH)

    Dublin, D08 NHY1

  • Beaumont Hospital

    Dublin, D09V2N0

  • Galway Univeristy Hospitals

    Galway, H91 YR71

Other trials in Ireland

United Kingdom3 sites

  • Leeds Teaching Hospitals NHS

    Leeds, LS2 9JT

  • St. Bartholomew's hospital

    London, EC1A 7BE

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Belgium2 sites

  • az Glorieux

    Ronse, 9600

  • CHU UC Louvain Namur

    Yvoir, 5530

Other trials in Belgium

Sweden2 sites

  • Karolinska University Hospital

    Stockholm, 141 86

  • Region Gävleborg Gävle Sjukhus Gävle Sjukhus

    Uppsala, 803 24

Other trials in Sweden

About this study

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)

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.

Read the 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

Being tested
Ivonescimab Injection, Pembrolizumab Injection
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ivonescimab InjectionBiological

    Subject will receive ivonescimab and chemotherapy as an IV injection

  • Pembrolizumab InjectionBiological

    Subject will receive pembrolizumab and chemotherapy as an IV injection

Study groups in NCT05899608
Study groupRoleWhat they receive
Arm A - Ivonescimab and chemotherapyExperimentalSubject will receive ivonescimab and chemotherapy
Receives: Biological: Ivonescimab Injection
Arm B - Pembrolizumab and chemotherapyActive comparatorSubject will receive pembrolizumab and chemotherapy
Receives: Biological: Pembrolizumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival (OS) in the ITT population

    Measured: approximately 4 years

  2. Progression Free Survival (PFS)

    Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1

    Measured: approximately 3 years

Secondary outcomes (1)

  1. Adverse Event (AE)

    incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start26 Oct 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05899608
Sponsor's protocol ID
SMT112-3003
Status last verified
Oct 2026
First submitted
1 Jun 2023
Last updated
8 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ivonescimab Injection and Pembrolizumab Injection in people with Non-Small Cell Lung Cancer, run by Summit Therapeutics at 260 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 260 sites in United States, China, Spain, Japan, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: approximately 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05899608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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