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NCT06767514PHASE3Recruiting

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

Summit Therapeutics

Start Date

2/27/2025

Completion Date

6/1/2029

Summary

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

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 - 1 * Expected life expectancy ≥ 3 months * Metastatic (Stage IV) NSCLC * Histologically or cytologically confirmed squamous or non-squamous NSCLC * Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities. * 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 for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization. * Has received any prior therapy for NSCLC in the metastatic setting. * Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up. * Known actionable genomic alterations for which first-line approved therapies are indicated * Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease * Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization * Active autoimmune or lung disease requiring systemic therapy * Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5 * Severe infection within 4 weeks prior to randomization * Major surgical procedures or serious trauma within 4 weeks prior to randomization * History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease

Interventions

BIOLOGICAL

Ivonescimab Injection

BIOLOGICAL

Pembrolizumab Injection

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Conditions

Non-Small Cell Lung Cancer

Locations

Clinical Study Site

Chandler, Arizona 85224

United States

Clinical Study Site

Phoenix, Arizona 85006

United States

Clinical Study Site

Hot Springs, Arkansas 71913

United States

Clinical Study Sites

Jonesboro, Arkansas 72401

United States

Clinical Study Site

Alameda, California 90720

United States

Clinical Study Site

Anaheim, California 92805

United States

Clinical Study Site

Beverly Hills, California 90211

United States

Clinical Study Site

Cerritos, California 90703

United States

Clinical Study Site

Los Angeles, California 90034

United States

Clinical Study Site

Los Angeles, California 90067

United States

Clinical Study Site

Orange, California 92868

United States

Clinical Study Site

Oxnard, California 93030

United States

Clinical Study Site

San Diego, California 92123

United States

Clinical Study Site

Sunnyvale, California 94086

United States

Clinical Study Site

Torrance, California 90505

United States

Clinical Study Site

Aurora, Colorado 80045

United States

Clinical Study Site

Denver, Colorado 80210

United States

Clinical Study Site

Grand Junction, Colorado 81505

United States

Clinical Study Site

Lone Tree, Colorado 80124

United States

Clinical Study Site

Loveland, Colorado 80538

United States

Clinical Study Sites

Fort Lauderdale, Florida 33308

United States

Clinical Study Site

Fort Lauderdale, Florida 33317

United States

Clinical Study Site

Jacksonville, Florida 32207

United States

Clinical Study Site

Jacksonville Beach, Florida 32256

United States

Clinical Study Site

North Venice, Florida 34275

United States

Clinical Study Site

Orlando, Florida 32822

United States

Clinical Study Site

Pensacola, Florida 32504

United States

Clinical Study Site

Plantation, Florida 33323

United States

Clinical Study Site

Tallahassee, Florida 32308

United States

Clinical Study Site

Tamarac, Florida 33321

United States

Clinical Study Site

West Palm Beach, Florida 33401

United States

Clinical Study Site

Atlanta, Georgia 30318

United States

Clinical Study Site

Warner Robins, Georgia 31088

United States

Clinical Study Site

Carterville, Illinois 62918

United States

Clinical Study Site

Chicago, Illinois 60611

United States

Clinical Study Site

Chicago, Illinois 60612

United States

Clinical Study Site

Evanston, Illinois 60201

United States

Clinical Study Site

Indianapolis, Indiana 46237

United States

Clinical Study Site

Waukee, Iowa 50263

United States

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Lexington, Kentucky 40503

United States

Clinical Study Site

Covington, Louisiana 70433

United States

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Baltimore, Maryland 21229

United States

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Boston, Massachusetts 02215

United States

Clinical Study Site

Brighton, Massachusetts 21350

United States

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Foxborough, Massachusetts 02035

United States

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Methuen, Massachusetts 01844

United States

Clinical Study Site

Milford, Massachusetts 01757

United States

Clinical Study Site

Weymouth, Massachusetts 02190

United States

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Worcester, Massachusetts 01655

United States

Clinical Study Site

Ann Arbor, Michigan 48109

United States

Clinical Study Site

Detroit, Michigan 48201

United States

Clinical Study Sites

Detroit, Michigan 48202

United States

Clinical Study Sites

Duluth, Minnesota 55805

United States

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Minneapolis, Minnesota 55455

United States

Clinical Study Site

Saint Paul, Minnesota 55101

United States

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Hattiesburg, Mississippi 39401

United States

Clinical Study Site

Kansas City, Missouri 64132

United States

Clinical Study Site

St Louis, Missouri 63128

United States

Clinical Study Site

St Louis, Missouri 63141

United States

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Lebanon, New Hampshire 03756

United States

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Mullica Hill, New Jersey 08062

United States

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New Brunswick, New Jersey 08901

United States

Clinical Study Site

New York, New York 10065

United States

Clinical Study Site

Syracuse, New York 13210

United States

Clinical Site

The Bronx, New York 10461

United States

Clinical Study Site

Chapel Hill, North Carolina 27514

United States

Clinical Study Site

Durham, North Carolina 27708

United States

Clinical Study Site

Pinehurst, North Carolina 28374

United States

Clinical Study Sites

Cincinnati, Ohio 45220

United States

Clinical Study Site

Cleveland, Ohio 44195

United States

Clinical Study Sites

Columbus, Ohio 43210

United States

Clinical Study Site

Columbus, Ohio 43219

United States

Clinical Study Site

Oklahoma City, Oklahoma 73102

United States

Clinical Study Site

Eugene, Oregon 97401

United States

Clinical Study Site

Portland, Oregon 97239

United States

Clinical Study Site

Philadelphia, Pennsylvania 19111

United States

Clinical Study Site

Pittsburgh, Pennsylvania 15232

United States

Clinical Study Sites

Nashville, Tennessee 37203

United States

Clinical Study Site

Nashville, Tennessee 37235

United States

Clinical Study Site

Abilene, Texas 79601

United States

Clinical Study Site

Austin, Texas 78745

United States

Clinical Study Site

Dallas, Texas 75246

United States

Clinical Study Site

Fort Worth, Texas 76104

United States

Clinical Study Site

Houston, Texas 77030

United States

Clinical Study Site

Tyler, Texas 75708

United States

Clinical Study Site

Webster, Texas 77598

United States

Clinical Study Site

Salt Lake City, Utah 84106

United States

Clinical Study Site

Blacksburg, Virginia 24061

United States

Clinical Study Site

Charlottesville, Virginia 22908

United States

Clinical Study Site

Fairfax, Virginia 22031

United States

Clinical Study Site

Richmond, Virginia 23229

United States

Clinical Study Site

Richmond, Virginia 23298

United States

Clinical Study Site

Seattle, Washington 98109

United States

Clinical Study Site

Vancouver, Washington 98684

United States

Clinical Study Site

Mons, Hainaut 07000

Belgium

Clinical Study Site

Charleroi, 09600

Belgium

Clinical Study Site

Ghent, 09000

Belgium

Clinical Study Site

Edmonton, Alberta T6G 1Z2

Canada

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Etobicoke, Ontario M9V 1R8

Canada

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London, Ontario N6A 5W9

Canada

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Montreal, Quebec H3T 1E2

Canada

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Fuyang, Anhui

China

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Beijing, Beijing Municipality

China

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Fuzhou, Fujian

China

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Guangzhou, Guangdong

China

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Nanning, Guangxi

China

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Guiyang, Guizhou

China

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Haikou, Hainan

China

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Harbin, Heilongjiang 150081

China

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Luoyang, Henan

China

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Nanyang, Henan

China

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Zhengzhou, Henan

China

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Changsha, Hunan

China

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Zhuzhou, Hunan

China

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Hohhot, Inner Mongolia

China

Clinical Site Study

Changzhou, Jiangsu

China

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Ganzhou, Jiangxi

China

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Nanchang, Jiangxi

China

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Changchun, Jilin

China

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Shenyang, Liaoning

China

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Jinan, Shandong

China

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Qingdao, Shandong

China

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Tai’an, Shandong

China

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Weifang, Shandong

China

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Xi’an, Shanxi

China

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Chengdu, Sichuan

China

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Luzhou, Sichuan

China

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Weihui, Xinxiang

China

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Kunming, Yunnan

China

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Hangzhou, Zhejiang

China

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Taizhou, Zhejiang

China

Clinical Site Study

Wenzhou, Zhejiang

China

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Beijing,

China

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Shanghai,

China

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Tianjin,

China

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Nantes, Pays de Loire 44277

France

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Avignon,

France

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Brest, 29200

France

Clinical Study Site

Créteil, 94010

France

Clinical Study Site

Lille, 59000

France

Clinical Study Site

Lyon, 69008

France

Clinical Study Site

Marseille, 13000

France

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Paris, 75020

France

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Paris, 75248

France

Clinical Study Site

Rennes, 35033

France

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Strasbourg,

France

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Toulon,

France

Clinical Study Site

Toulouse,

France

Clinical Study Site

Villejuif, 94800

France

Clinical Study Site

Chemnitz, 09116

Germany

Clinical Study Sites

Esslingen am Neckar, 73701

Germany

Clinical Study Site

Gauting, 82131

Germany

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Giesen, 35392

Germany

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Herne, 44651

Germany

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Karlsruhe, 76137

Germany

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Minden, 32429

Germany

Clinical Study Site

Möser, 47441

Germany

Clinical Study Site

Athens, 10431

Greece

Clinical Study Sites

Athens, 12462

Greece

Clinical Study Site

Athens, 15562

Greece

Clinical Study Sites

Athens, 18547

Greece

Clinical Study Site

Rio, 26504

Greece

Clinical Study Site

Thessaloniki, 54622

Greece

Clinical Study Site

Budapest, 01121

Hungary

Clinical Study Site

Budapest, 01122

Hungary

Clinical Study Site

Gyöngyös, 03200

Hungary

Clinical Study Site

Kecskemét, 06000

Hungary

Clinical Study Site

Rome, Italy 00189

Italy

Clinical Study Site

Bari, 70124

Italy

Clinical Study Site

Bergamo, 24125

Italy

Clinical Study Site

Milan, 20037

Italy

Clinical Study Site

Milan, 20133

Italy

Clinical Study Site

Milan, 20141

Italy

Clinical Study Sites

Orbassano, 10043

Italy

Clinical Study Site

Parma, 43126

Italy

Clinical Study Site

Rome, 00144

Italy

Clinical Study Site

Nagoya, Aichi-ken 460-0001

Japan

Clinical Study Site

Kurume, Fukuoka 830-0011

Japan

Clinical Study Site

Asahikawa, Hokkaido 078-8510

Japan

Clinical Study Site

Nishinomiya, Hyōgo 663-8501

Japan

Clinical Study Site

Kanazawa, Ishikawa-ken 920-8641

Japan

Clinical Study Site

Tokyo, Japan 104-0045

Japan

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Kumamoto, Kumamoto 861-4193

Japan

Clinical Study Sites

Kyoto, Kyoto 602-8566

Japan

Clinical Study Site

Matsusaka, Mie-ken 515-8544

Japan

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Sendai, Miyagi 980-8574

Japan

Clinical Study Site

Omura-shi, Nagasaki 856-8562

Japan

Clinical Study Site

Okayama, Okayama-ken 700-8558

Japan

Clinical Study Site

Hirakata, Osaka 573-1191

Japan

Clinical Study Site

Osaka, Osaka 541-8567

Japan

Clinical Study Site

Hidaka, Saitama 350-1298

Japan

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Shimotsuke, Tochigi 329-0498

Japan

Clinical Study Site

Bunkyō-Ku, Tokyo 113-8677

Japan

Clinical Study Site

Koto-Ku, Tokyo 135-8550

Japan

Clinical Study Site

Wakayama, Wakayama 641-8510

Japan

Clinical Study Site

Sakai, 591-8555

Japan

Clinical Study Site

Guadalajara, 44670

Mexico

Clinical Study Site

Guadalajara, 44680

Mexico

Clinical Study Site

Jalisco, 44680

Mexico

Clinical Study Site

Mexico City, 06700

Mexico

Clinical Study Sites

Mexico City, 10200

Mexico

Clinical Study Site

Mexico City, 14080

Mexico

Clinical Study Site

Monterrey, 64710

Mexico

Clinical Study Site

Veracruz, 91900

Mexico

Clinical Study Site

Gdansk, 80214

Poland

Clinical Study Site

Lodz, 93338

Poland

Clinical Study Site

Lublin, 20064

Poland

Clinical Study Site

Poznan, 60693

Poland

Clinical Study Site

Skorzewo, 60185

Poland

Clinical Study Site

Braga, Braga District 4710-243

Portugal

Clinical Study Site

Lisbon, Lisban 1400-038

Portugal

Clinical Study Site

Porto, Portugal 4200-072

Portugal

Clinical Study Site

Coimbra, 3020-479

Portugal

Clinical Study Site

Faro, 8000-386

Portugal

Clinical Study Site

Porto, 4099-001

Portugal

Clinical Study Site

Cluj-Napoca, Cluj 400015

Romania

Clinical Study Site

Cluj-Napoca, Cluj 400641

Romania

Clinical Study Site

Cluj-Napoca, Cluj 407280

Romania

Clinical Study Site

Suceagu, Cluj 407062

Romania

Clinical Study Site

Ovidiu, Constanța County 905900

Romania

Clinical Study Site

Craiova, Dolj 200542

Romania

Clinical Study Site

Iași, Iaşi 700106

Romania

Clinical Study Site

Baia Mare, Maramureş 430031

Romania

Clinical Study Site

Timișoara, Timiș County 300166

Romania

Clinical Study Site

Timișoara, Timiș County 300425

Romania

Clinical Study Site

Bucharest, 022328

Romania

Clinical Study Site

Belgrade, 11040

Serbia

Clinical Study Site

Belgrade, 11080

Serbia

Clinical Study Site

Kragujevac, 34000

Serbia

Clinical Study Site

Novi Sad, 21204

Serbia

Clinical Study Site

Barakaldo, Bizkaia 48903

Spain

Clinical Study Site

Santander, Cantabria 39008

Spain

Clinical Study Site

Badajoz, Extremadura 06080

Spain

Clinical Study Site

Las Palmas, Las Palmas 35016

Spain

Clinical Study Site

Madrid, Madrid 28007

Spain

Clinical Study Site

Madrid, Madrid 28040

Spain

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Sevilla, Madrid 41014

Spain

Clinical Study Site

Marbella, Malaga 29660

Spain

Clinical Study Site

Madrid, Martin Lagos 28040

Spain

Clinical Study Site

Seville, Seville 41009

Spain

Clinical Study Site

Barcelona, Spain 08003

Spain

Clinical Study Site

Barcelona, Spain 08908

Spain

Clinical Study Site

Madrid, Spain 28034

Spain

Clinical Study Site

Madrid, Spain 28041

Spain

Clinical Study Site

Badalona, 08916

Spain

Clinical Study Site

Burgos, 09006

Spain

Clinical Study Site

Girona, 17007

Spain

Clinical Study Site

Lugo, 27002

Spain

Clinical Study Site

Málaga, 29011

Spain

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Seville, 41014

Spain

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Valencia, 46010

Spain

Clinical Study Site

Valencia, 46026

Spain

Clinical Study Site

Zaragoza, 50009

Spain

Clinical Study Site

Istanbul, Bahcelievler 34180

Turkey (Türkiye)

Clinical Study Site

Ankara, Yenimahalle 06200

Turkey (Türkiye)

Clinical Study Site

Adana, 01230

Turkey (Türkiye)

Clinical Study Site

Ankara, 06010

Turkey (Türkiye)

Clinical Study Site

Ankara, 06230

Turkey (Türkiye)

Clinical Study Site

Ankara, 06520

Turkey (Türkiye)

Clinical Study Site

Ankara, 06590

Turkey (Türkiye)

Clinical Study Site

Antalya, 07059

Turkey (Türkiye)

Clinical Study Site

Diyarbakır, 21280

Turkey (Türkiye)

Clinical Study Site

Gaziantep, 27060

Turkey (Türkiye)

Clinical Study Site

Istanbul, 34098

Turkey (Türkiye)

Clinical Study Site

Istanbul, 34460

Turkey (Türkiye)

Clinical Study Site

Istanbul, 34722

Turkey (Türkiye)

Clinical Study Site

Izmir, 35100

Turkey (Türkiye)

Clinical Study Site

İzmit, 41380

Turkey (Türkiye)

Clinical Study Site

Konya, 42080

Turkey (Türkiye)

Clinical Study Site

Seyhan, 01140

Turkey (Türkiye)