RecruitingPhase 3NCT06767514

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

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

Sponsor

Summit Therapeutics

Enrollment

780 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying ivonescimab — a new drug that blocks both the PD-1 immune checkpoint and a blood vessel growth factor (VEGF) — combined with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. **You may be eligible if...** - You are 18 or older and have been diagnosed with stage IV (metastatic) non-small cell lung cancer - Your tumor shows high PD-L1 expression (TPS greater than 50%) on a standard test - You have not yet received any systemic treatment for metastatic NSCLC - Your cancer is either squamous or non-squamous cell type - You have at least one measurable tumor outside the brain - Your general health is good (ECOG score 0 or 1) and expected survival is at least 3 months **You may NOT be eligible if...** - Your lung cancer is small cell type - Your tumor has a known actionable driver mutation (like EGFR or ALK) for which targeted therapy exists - You have active brain metastases requiring treatment - You have a history of autoimmune disease requiring steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIvonescimab Injection

Subject will receive ivonescimab as an IV injection

BIOLOGICALPembrolizumab Injection

Subject will receive Pembrolizumab as an IV injection

Locations(202)

Clinical Study Site

Chandler, Arizona, United States

Clinical Study Site

Phoenix, Arizona, United States

Clinical Study Site

Hot Springs, Arkansas, United States

Clinical Study Site

Cerritos, California, United States

Clinical Study Site

Glendale, California, United States

Clinical Study Site

Irvine, California, United States

Clinical Study Site

Los Angeles, California, United States

Clinical Study Site

Mountain View, California, United States

Clinical Study Site

Murrieta, California, United States

Clinical Study Site

Newport Beach, California, United States

Clinical Study Site

Roseville, California, United States

Clinical Study Site

Sacramento, California, United States

Clinical Study Site

San Diego, California, United States

Clinical Study Site

San Francisco, California, United States

Clinical Study Site

Santa Ana, California, United States

Clinical Study Site

Whittier, California, United States

Clinical Study Site

Aurora, Colorado, United States

Clinical Study Site

Grand Junction, Colorado, United States

Clinical Study Site

Greeley, Colorado, United States

Clinical Study Site

Lone Tree, Colorado, United States

Clinical Study Site

Loveland, Colorado, United States

Clinical Study Site

Fort Lauderdale, Florida, United States

Clinical Study Site

Hialeah, Florida, United States

Clinical Study Site

Jacksonville, Florida, United States

Clinical Study Site

Miami, Florida, United States

Clinical Study Site

North Venice, Florida, United States

Clinical Study Site

Orlando, Florida, United States

Clinical Study Site

Pensacola, Florida, United States

Clinical Study Site

Plantation, Florida, United States

Clinical Study Site

Plantation, Florida, United States

Clinical Study Site

Tallahassee, Florida, United States

Clinical Study Site

Tamarac, Florida, United States

Clinical Study Site

West Palm Beach, Florida, United States

Clinical Study Site

Atlanta, Georgia, United States

Clinical Study Site

Macon, Georgia, United States

Clinical Study Site

Macon, Georgia, United States

Clinical Study Site

Carterville, Illinois, United States

Clinical Study Site

Indianapolis, Indiana, United States

Clinical Study Site

Waukee, Iowa, United States

Clinical Study Site

Lexington, Kentucky, United States

Clinical Study Site

Covington, Louisiana, United States

Clinical Study Site

Baltimore, Maryland, United States

Clinical Study Site

Boston, Massachusetts, United States

Clinical Study Site

Milton, Massachusetts, United States

Clinical Study Site

Worcester, Massachusetts, United States

Clinical Study Sites

Detroit, Michigan, United States

Clinical Study Site

Detroit, Michigan, United States

Clinical Study Site

Lansing, Michigan, United States

Clinical Study Site

Minneapolis, Minnesota, United States

Clinical Study Site

Saint Louis Park, Minnesota, United States

Clinical Study Site

Saint Paul, Minnesota, United States

Clinical Study Site

Hattiesburg, Mississippi, United States

Clinical Study Site

Kansas City, Missouri, United States

Clinical Study Site

St Louis, Missouri, United States

Clinical Study Site

Lebanon, New Hampshire, United States

Clinical Study Site

Basking Ridge, New Jersey, United States

Clinical Study Site

Middletown, New Jersey, United States

Clinical Study Site

Montvale, New Jersey, United States

Clinical Study Site

Mullica Hill, New Jersey, United States

Clinical Study Site

New Brunswick, New Jersey, United States

Clinical Study Site

Glen Falls, New York, United States

Clinical Study Site

Harrison, New York, United States

Clinical Study Site

New York, New York, United States

Clinical Study Site

Syracuse, New York, United States

Clinical Study Site

Uniondale, New York, United States

Clinical Study Site

Chapel Hill, North Carolina, United States

Clinical Study Site

Columbus, Ohio, United States

Clinical Study Sites

Lebanon, Ohio, United States

Clinical Study Site

Oklahoma City, Oklahoma, United States

Clinical Study Site

Eugene, Oregon, United States

Clinical Study Site

Portland, Oregon, United States

Clinical Study Site

Philadelphia, Pennsylvania, United States

Clinical Study Site

Pittsburgh, Pennsylvania, United States

Clinical Study Site

Nashville, Tennessee, United States

Clinical Study Site

Abilene, Texas, United States

Clinical Study Site

Austin, Texas, United States

Clinical Study Site

Dallas, Texas, United States

Clinical Study Site

Forth Worth, Texas, United States

Clinical Study Site

Houston, Texas, United States

Clinical Study Site

Tyler, Texas, United States

Clinical Study Site

Webster, Texas, United States

Clinical Study Site

Salt Lake City, Utah, United States

Clinical Study Site

Blacksburg, Virginia, United States

Clinical Study Site

Charlottesville, Virginia, United States

Clinical Study Site

Fairfax, Virginia, United States

Clinical Study Site

Richmond, Virginia, United States

Clinical Study Site

Richmond, Virginia, United States

Clinical Study Site

Seattle, Washington, United States

Clinical Study Site

Vancouver, Washington, United States

Clinical Study Site

Edmonton, Alberta, Canada

Clinical Study Site

London, Ontario, Canada

Clinical Study Site

Montreal, Quebec, Canada

Clinical Study Site

Montreal, Canada

Clinical Study Site

Fuzhou, Fujian, China

Clinical Study Site

Guangzhou, Guangdong, China

Clinical Study Site

Haikou, Hainan, China

Clinical Study Site

Harbin, Heilongjiang, China

Clinical Site Study

Changzhou, Jiangsu, China

Clinical Study Site

Ganzhou, Jiangxi, China

Clinical Study Site

Nanchang, Jiangxi, China

Clinical Study Site

Tai’an, Shandong, China

Clinical Study Site

Weifang, Shandong, China

Clinical Study Site

Shanghai, Shanghai Municipality, China

Clinical Study Site

Kunming, Yunnan, China

Clinical Study Site

Hangzhou, Zhejiang, China

Clinical Study Site

Taizhou, Zhejiang, China

Clinical Site Study

Wenzhou, Zhejiang, China

Clinical Study Site

Changchun, China

Clinical Study Site

Guangzhou, China

Clinical Study Site

Xi'an, China

Clinical Study Site

Nantes, Pays de Loire, France

Clinical Study Site

Brest, France

Clinical Study Site

Créteil, France

Clinical Study Site

Lyon, France

Clinical Study Site

Marseille, France

Clinical Study Site

Paris, France

Clinical Study Site

Rennes, France

Clinical Study Site

Villejuif, France

Clinical Study Site

Chemnitz, Germany

Clinical Study Site

Gauting, Germany

Clinical Study Site

Giesen, Germany

Clinical Study Site

Karlsruhe, Germany

Clinical Study Site

Minden, Germany

Clinical Study Site

Moers, Germany

Clinical Study Site

Möser, Germany

Clinical Study Site

Athens, Greece

Clinical Study Site

Rio, Greece

Clinical Study Site

Thessaloniki, Greece

Clinical Study Site

Budapest, Hungary

Clinical Study Site

Kecskemét, Hungary

Clinical Study Site

Bari, Italy

Clinical Study Site

Milan, Italy

Clinical Study Site

Milan, Italy

Clinical Study Site

Orbassano, Italy

Clinical Study Site

Parma, Italy

Clinical Study Site

Roma, Italy

Clinical Study Site

Asahikawa, Hokkaido, Japan

Clinical Study Site

Nishinomiya, Hyōgo, Japan

Clinical Study Site

Matsusaka, Mie-ken, Japan

Clinical Study Site

Sendai, Miyagi, Japan

Clinical Study Site

Omura-shi, Nagasaki, Japan

Clinical Study Site

Hirakata, Osaka, Japan

Clinical Study Site

Osaka, Osaka, Japan

Clinical Study Site

Hidaka, Saitama, Japan

Clinical Study Site

Shimotsuke, Tochigi, Japan

Clinical Study Site

Bunkyō-Ku, Tokyo, Japan

Clinical Study Site

Koto-Ku, Tokyo, Japan

Clinical Study Site

Wakayama, Wakayama, Japan

Clinical Study Site

Kanazawa, Japan

Clinical Study Site

Kumamoto, Japan

Clinical Study Site

Kurume, Japan

Clinical Study Site

Nagoya, Japan

Clinical Study Site

Okayama, Japan

Clinical Study Site

Sakai, Japan

Clinical Study Site

Tokyo, Japan

Clinical Study Site

Guadalajara, Mexico

Clinical Study Site

Mexico City, Mexico

Clinical Study Site

Monterrey, Mexico

Clinical Study Site

Veracruz, Mexico

Clinical Study Site

Gdansk, Poland

Clinical Study Site

Lodz, Poland

Clinical Study Site

Lublin, Poland

Clinical Study Site

Poznan, Poland

Clinical Study Site

Skorzewo, Poland

Clinical Study Site

Braga, Portugal

Clinical Study Site

Coimbra, Portugal

Clinical Study Site

Faro, Portugal

Clinical Study Site

Porto, Portugal

Clinical Study Site

Suceagu, Cluj, Romania

Clinical Study Site

Baia Mare, Romania

Clinical Study Site

Bucharest, Romania

Clinical Study Site

Cluj-Napoca, Romania

Clinical Study Site

Cluj-Napoca, Romania

Clinical Study Site

Craiova, Romania

Clinical Study Site

Iași, Romania

Clinical Study Site

Ovidiu, Romania

Clinical Study Site

Timișoara, Romania

Clinical Study Site

Belgrade, Serbia

Clinical Study Site

Belgrade, Serbia

Clinical Study Site

Kragujevac, Serbia

Clinical Study Site

Novi Sad, Serbia

Clinical Study Site

Badajoz, Spain

Clinical Study Site

Badalona, Spain

Clinical Study Site

Barcelona, Spain

Clinical Study Site

Girona, Spain

Clinical Study Site

Las Palmas, Spain

Clinical Study Site

Lugo, Spain

Clinical Study Site

Madrid, Spain

Clinical Study Site

Málaga, Spain

Clinical Study Site

Seville, Spain

Clinical Study Site

Valencia, Spain

Clinical Study Site

Zaragoza, Spain

Clinical Study Site

Adana, Turkey (Türkiye)

Clinical Study Site

Ankara, Turkey (Türkiye)

Clinical Study Site

Antalya, Turkey (Türkiye)

Clinical Study Site

Diyarbakır, Turkey (Türkiye)

Clinical Study Site

Gaziantep, Turkey (Türkiye)

Clinical Study Site

Istanbul, Turkey (Türkiye)

Clinical Study Site

Istanbul, Turkey (Türkiye)

Clinical Study Site

İzmit, Turkey (Türkiye)

Clinical Study Site

Konya, Turkey (Türkiye)

Clinical Study Site

Seyhan, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT06767514

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