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NCT05899608PHASE3Recruiting

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

Summit Therapeutics

Start Date

10/26/2023

Completion Date

12/31/2029

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.

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

Ivonescimab Injection

BIOLOGICAL

Pembrolizumab Injection

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Conditions

Non-Small Cell Lung Cancer

Locations

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