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
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
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Phoenix, Arizona, United States
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Hot Springs, Arkansas, United States
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Cerritos, California, United States
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Glendale, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Mountain View, California, United States
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Murrieta, California, United States
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Newport Beach, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Grand Junction, Colorado, United States
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Greeley, Colorado, United States
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Lone Tree, Colorado, United States
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Loveland, Colorado, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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North Venice, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Plantation, Florida, United States
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Plantation, Florida, United States
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Tallahassee, Florida, United States
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Tamarac, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Macon, Georgia, United States
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Carterville, Illinois, United States
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Indianapolis, Indiana, United States
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Waukee, Iowa, United States
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Lexington, Kentucky, United States
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Covington, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Milton, Massachusetts, United States
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Worcester, Massachusetts, United States
Clinical Study Sites
Detroit, Michigan, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Saint Paul, Minnesota, United States
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Hattiesburg, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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Basking Ridge, New Jersey, United States
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Middletown, New Jersey, United States
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Montvale, New Jersey, United States
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Mullica Hill, New Jersey, United States
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New Brunswick, New Jersey, United States
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Glen Falls, New York, United States
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Harrison, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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Uniondale, New York, United States
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Chapel Hill, North Carolina, United States
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Columbus, Ohio, United States
Clinical Study Sites
Lebanon, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Forth Worth, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Webster, Texas, United States
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Salt Lake City, Utah, United States
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Blacksburg, Virginia, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Vancouver, Washington, United States
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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Canada
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Fuzhou, Fujian, China
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Guangzhou, Guangdong, China
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Haikou, Hainan, China
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Harbin, Heilongjiang, China
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Changzhou, Jiangsu, China
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Ganzhou, Jiangxi, China
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Nanchang, Jiangxi, China
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Tai’an, Shandong, China
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Weifang, Shandong, China
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Shanghai, Shanghai Municipality, China
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Kunming, Yunnan, China
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Hangzhou, Zhejiang, China
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Taizhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Changchun, China
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Guangzhou, China
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Xi'an, China
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Nantes, Pays de Loire, France
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Brest, France
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Créteil, France
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Lyon, France
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Marseille, France
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Paris, France
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Rennes, France
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Villejuif, France
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Chemnitz, Germany
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Gauting, Germany
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Giesen, Germany
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Karlsruhe, Germany
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Minden, Germany
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Moers, Germany
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Möser, Germany
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Athens, Greece
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Rio, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Kecskemét, Hungary
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Bari, Italy
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Milan, Italy
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Milan, Italy
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Orbassano, Italy
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Parma, Italy
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Roma, Italy
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Asahikawa, Hokkaido, Japan
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Nishinomiya, Hyōgo, Japan
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Matsusaka, Mie-ken, Japan
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Sendai, Miyagi, Japan
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Omura-shi, Nagasaki, Japan
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Hirakata, Osaka, Japan
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Osaka, Osaka, Japan
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Hidaka, Saitama, Japan
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Shimotsuke, Tochigi, Japan
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Bunkyō-Ku, Tokyo, Japan
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Koto-Ku, Tokyo, Japan
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Wakayama, Wakayama, Japan
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Kanazawa, Japan
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Kumamoto, Japan
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Kurume, Japan
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Nagoya, Japan
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Okayama, Japan
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Sakai, Japan
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Tokyo, Japan
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Guadalajara, Mexico
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Mexico City, Mexico
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Monterrey, Mexico
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Veracruz, Mexico
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Gdansk, Poland
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Lodz, Poland
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Lublin, Poland
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Poznan, Poland
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Skorzewo, Poland
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Braga, Portugal
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Coimbra, Portugal
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Faro, Portugal
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Porto, Portugal
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Suceagu, Cluj, Romania
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Baia Mare, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Iași, Romania
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Ovidiu, Romania
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Timișoara, Romania
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Belgrade, Serbia
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Belgrade, Serbia
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Kragujevac, Serbia
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Novi Sad, Serbia
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Badajoz, Spain
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Badalona, Spain
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Barcelona, Spain
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Girona, Spain
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Las Palmas, Spain
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Lugo, Spain
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Madrid, Spain
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Málaga, Spain
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Seville, Spain
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Valencia, Spain
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Zaragoza, Spain
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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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
For the most up-to-date information, visit the official listing.