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

NCT06767514 · Summit Therapeutics
In plain English

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Official title
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
About this study
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
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
Study design
Enrollment target: 780 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-02-27
Estimated completion: 2029-06
Last updated: 2026-02-24
Interventions
Biological: Ivonescimab InjectionBiological: Pembrolizumab Injection
Primary outcomes
  • Overall Survival (OS) (Up to approximately 36 months)
  • Progression free survival (PFS) (Up to approximately 36 months)
Sponsor
Summit Therapeutics · industry
Contacts & investigators
ContactSummit Clinical Trial Information · contact · medicalinformation@smmttx.com · 1-833-256-0522
All locations (202)
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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
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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
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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)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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İzmit, Turkey (Türkiye)
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Konya, Turkey (Türkiye)
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Seyhan, Turkey (Türkiye)
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1 · TrialPath