Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1 (HARMONi-7)
August 18, 2026 updated by: Summit Therapeutics
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
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1.
Evaluating overall survival and progression free survival.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
780
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Summit Clinical Trial Information
- Phone Number: 1-833-256-0522
- Email: medicalinformation@smmttx.com
Study Locations
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Charleroi, Belgium, 09600
- Recruiting
- Clinical Study Site
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Ghent, Belgium, 09000
- Recruiting
- Clinical Study Site
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Hainaut
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Mons, Hainaut, Belgium, 07000
- Recruiting
- Clinical Study Site
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Recruiting
- Clinical Study Site
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Ontario
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Etobicoke, Ontario, Canada, M9V 1R8
- Recruiting
- Clinical Study Site
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London, Ontario, Canada, N6A 5W9
- Recruiting
- Clinical Study Site
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Recruiting
- Clinical Study Site
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Beijing, China
- Recruiting
- Clinical Study Site
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Shanghai, China
- Recruiting
- Clinical Study Site
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Tianjin, China
- Recruiting
- Clinical Study Sites
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Anhui
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Fuyang, Anhui, China
- Recruiting
- Clinical Study Site
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Beijing Municipality
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Beijing, Beijing Municipality, China
- Recruiting
- Clinical Study Site
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Fujian
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Fuzhou, Fujian, China
- Recruiting
- Clinical Study Site
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Clinical Study Site
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Guangxi
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Nanning, Guangxi, China
- Recruiting
- Clinical Study Site
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Guizhou
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Guiyang, Guizhou, China
- Recruiting
- Clinical Study Site
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Hainan
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Haikou, Hainan, China
- Recruiting
- Clinical Study Site
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
- Recruiting
- Clinical Study Site
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Henan
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Luoyang, Henan, China
- Recruiting
- Clinical Study Site
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Nanyang, Henan, China
- Recruiting
- Clinical Study Site
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Zhengzhou, Henan, China
- Recruiting
- Clinical Study Site
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Hunan
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Changsha, Hunan, China
- Recruiting
- Clinical Study Site
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Zhuzhou, Hunan, China
- Recruiting
- Clinical Study Site
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Inner Mongolia
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Hohhot, Inner Mongolia, China
- Recruiting
- Clinical Study Site
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Jiangsu
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Changzhou, Jiangsu, China
- Recruiting
- Clinical Site Study
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Jiangxi
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Ganzhou, Jiangxi, China
- Recruiting
- Clinical Study Site
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Nanchang, Jiangxi, China
- Recruiting
- Clinical Study Site
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Jilin
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Changchun, Jilin, China
- Recruiting
- Clinical Study Site
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Liaoning
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Shenyang, Liaoning, China
- Recruiting
- Clinical Study Site
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Shandong
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Jinan, Shandong, China
- Recruiting
- Clinical Study Site
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Qingdao, Shandong, China
- Recruiting
- Clinical Study Site
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Tai’an, Shandong, China
- Recruiting
- Clinical Study Site
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Weifang, Shandong, China
- Recruiting
- Clinical Study Site
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Shanxi
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Xi’an, Shanxi, China
- Recruiting
- Clinical Study Site
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Sichuan
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Chengdu, Sichuan, China
- Recruiting
- Clinical Study Site
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Luzhou, Sichuan, China
- Recruiting
- Clinical Study Site
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Xinxiang
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Weihui, Xinxiang, China
- Recruiting
- Clinical Study Site
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Yunnan
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Kunming, Yunnan, China
- Recruiting
- Clinical Study Site
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Zhejiang
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Hangzhou, Zhejiang, China
- Recruiting
- Clinical Study Site
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Taizhou, Zhejiang, China
- Recruiting
- Clinical Study Site
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Wenzhou, Zhejiang, China
- Recruiting
- Clinical Site Study
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Avignon, France
- Recruiting
- Clinical Study Site
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Brest, France, 29200
- Recruiting
- Clinical Study Site
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Créteil, France, 94010
- Recruiting
- Clinical Study Site
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Lille, France, 59000
- Recruiting
- Clinical Study Site
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Lyon, France, 69008
- Recruiting
- Clinical Study Site
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Marseille, France, 13000
- Recruiting
- Clinical Study Site
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Paris, France, 75020
- Recruiting
- Clinical Study Site
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Paris, France, 75248
- Recruiting
- Clinical Study Site
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Rennes, France, 35033
- Recruiting
- Clinical Study Site
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Strasbourg, France
- Recruiting
- Clinical Study Site
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Toulon, France
- Recruiting
- Clinical Study Site
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Toulouse, France
- Recruiting
- Clinical Study Site
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Villejuif, France, 94800
- Recruiting
- Clinical Study Site
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Pays de Loire
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Nantes, Pays de Loire, France, 44277
- Recruiting
- Clinical Study Site
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Chemnitz, Germany, 09116
- Recruiting
- Clinical Study Site
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Esslingen am Neckar, Germany, 73701
- Recruiting
- Clinical Study Sites
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Gauting, Germany, 82131
- Recruiting
- Clinical Study Site
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Giesen, Germany, 35392
- Recruiting
- Clinical Study Site
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Herne, Germany, 44651
- Recruiting
- Clinical Study Site
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Karlsruhe, Germany, 76137
- Recruiting
- Clinical Study Site
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Minden, Germany, 32429
- Recruiting
- Clinical Study Site
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Möser, Germany, 47441
- Recruiting
- Clinical Study Site
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Athens, Greece, 15562
- Recruiting
- Clinical Study Site
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Athens, Greece, 10431
- Recruiting
- Clinical Study Site
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Athens, Greece, 12462
- Recruiting
- Clinical Study Sites
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Athens, Greece, 18547
- Recruiting
- Clinical Study Sites
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Rio, Greece, 26504
- Recruiting
- Clinical Study Site
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Thessaloniki, Greece, 54622
- Recruiting
- Clinical Study Site
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Budapest, Hungary, 01121
- Recruiting
- Clinical Study Site
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Budapest, Hungary, 01122
- Recruiting
- Clinical Study Site
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Gyula, Hungary, 05700
- Recruiting
- Clinical Study Site
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Gyöngyös, Hungary, 03200
- Recruiting
- Clinical Study Site
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Kecskemét, Hungary, 06000
- Recruiting
- Clinical Study Site
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Bari, Italy, 70124
- Recruiting
- Clinical Study Site
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Bergamo, Italy, 24125
- Recruiting
- Clinical Study Site
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Milan, Italy, 20037
- Recruiting
- Clinical Study Site
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Milan, Italy, 20141
- Recruiting
- Clinical Study Site
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Milan, Italy, 20133
- Recruiting
- Clinical Study Site
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Orbassano, Italy, 10043
- Recruiting
- Clinical Study Sites
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Parma, Italy, 43126
- Recruiting
- Clinical Study Site
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Peschiera del Garda, Italy, 37019
- Recruiting
- Clinical Study Site
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Rome, Italy, 00144
- Recruiting
- Clinical Study Site
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Italy
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Rome, Italy, Italy, 00189
- Recruiting
- Clinical Study Site
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Sakai, Japan, 591-8555
- Recruiting
- Clinical Study Site
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 460-0001
- Recruiting
- Clinical Study Site
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
- Recruiting
- Clinical Study Site
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Hokkaido
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Asahikawa, Hokkaido, Japan, 078-8510
- Recruiting
- Clinical Study Site
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Hyōgo
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Nishinomiya, Hyōgo, Japan, 663-8501
- Recruiting
- Clinical Study Site
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Recruiting
- Clinical Study Site
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Japan
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Tokyo, Japan, Japan, 104-0045
- Recruiting
- Clinical Study Site
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Kumamoto
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Kumamoto, Kumamoto, Japan, 861-4193
- Recruiting
- Clinical Study Site
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Kyoto
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Kyoto, Kyoto, Japan, 602-8566
- Recruiting
- Clinical Study Sites
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Mie-ken
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Matsusaka, Mie-ken, Japan, 515-8544
- Recruiting
- Clinical Study Site
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Recruiting
- Clinical Study Site
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Nagasaki
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Omura-shi, Nagasaki, Japan, 856-8562
- Recruiting
- Clinical Study Site
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Okayama-ken
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Okayama, Okayama-ken, Japan, 700-8558
- Recruiting
- Clinical Study Site
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Recruiting
- Clinical Study Site
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Osaka, Osaka, Japan, 541-8567
- Recruiting
- Clinical Study Site
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Contact:
- Clinical Study Site Clinical Study Site
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Saitama
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Hidaka, Saitama, Japan, 350-1298
- Recruiting
- Clinical Study Site
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Tochigi
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Shimotsuke, Tochigi, Japan, 329-0498
- Recruiting
- Clinical Study Site
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Tokyo
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Bunkyō-Ku, Tokyo, Japan, 113-8677
- Recruiting
- Clinical Study Site
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Koto-Ku, Tokyo, Japan, 135-8550
- Recruiting
- Clinical Study Site
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Wakayama
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Wakayama, Wakayama, Japan, 641-8510
- Recruiting
- Clinical Study Site
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Guadalajara, Mexico, 44670
- Recruiting
- Clinical Study Site
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Guadalajara, Mexico, 44680
- Recruiting
- Clinical Study Site
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Jalisco, Mexico, 44680
- Recruiting
- Clinical Study Site
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Mexico City, Mexico, 06700
- Recruiting
- Clinical Study Site
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Mexico City, Mexico, 10200
- Recruiting
- Clinical Study Sites
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Mexico City, Mexico, 14080
- Recruiting
- Clinical Study Site
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Monterrey, Mexico, 64710
- Recruiting
- Clinical Study Site
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Veracruz, Mexico, 91900
- Recruiting
- Clinical Study Site
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Mexico City
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Querétaro, Mexico City, Mexico, 76269
- Recruiting
- Clinical Study Site
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Gdansk, Poland, 80214
- Recruiting
- Clinical Study Site
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Lodz, Poland, 93338
- Recruiting
- Clinical Study Site
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Lublin, Poland, 20064
- Recruiting
- Clinical Study Site
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Poznan, Poland, 60693
- Recruiting
- Clinical Study Site
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Skorzewo, Poland, 60185
- Recruiting
- Clinical Study Site
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Coimbra, Portugal, 3020-479
- Recruiting
- Clinical Study Site
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Faro, Portugal, 8000-386
- Recruiting
- Clinical Study Site
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Porto, Portugal, 4099-001
- Recruiting
- Clinical Study Site
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Braga District
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Braga, Braga District, Portugal, 4710-243
- Recruiting
- Clinical Study Site
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Lisban
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Lisbon, Lisban, Portugal, 1400-038
- Recruiting
- Clinical Study Site
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Portugal
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Porto, Portugal, Portugal, 4200-072
- Recruiting
- Clinical Study Site
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Bucharest, Romania, 022328
- Recruiting
- Clinical Study Site
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Cluj
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Cluj-Napoca, Cluj, Romania, 400015
- Recruiting
- Clinical Study Site
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Cluj-Napoca, Cluj, Romania, 400641
- Recruiting
- Clinical Study Site
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Cluj-Napoca, Cluj, Romania, 407280
- Recruiting
- Clinical Study Site
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Suceagu, Cluj, Romania, 407062
- Recruiting
- Clinical Study Site
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Constanța County
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Ovidiu, Constanța County, Romania, 905900
- Recruiting
- Clinical Study Site
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Dolj
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Craiova, Dolj, Romania, 200542
- Recruiting
- Clinical Study Site
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Iaşi
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Iași, Iaşi, Romania, 700106
- Recruiting
- Clinical Study Site
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Maramureş
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Baia Mare, Maramureş, Romania, 430031
- Recruiting
- Clinical Study Site
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Timiș County
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Timișoara, Timiș County, Romania, 300166
- Recruiting
- Clinical Study Site
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Timișoara, Timiș County, Romania, 300425
- Recruiting
- Clinical Study Site
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Belgrade, Serbia, 11080
- Recruiting
- Clinical Study Site
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Belgrade, Serbia, 11040
- Recruiting
- Clinical Study Site
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Kragujevac, Serbia, 34000
- Recruiting
- Clinical Study Site
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Novi Sad, Serbia, 21204
- Recruiting
- Clinical Study Site
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Badalona, Spain, 08916
- Recruiting
- Clinical Study Site
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Burgos, Spain, 09006
- Recruiting
- Clinical Study Site
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Girona, Spain, 17007
- Recruiting
- Clinical Study Site
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Lugo, Spain, 27002
- Recruiting
- Clinical Study Site
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Málaga, Spain, 29011
- Recruiting
- Clinical Study Site
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Seville, Spain, 41014
- Recruiting
- Clinical Study Site
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Valencia, Spain, 46026
- Recruiting
- Clinical Study Site
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Valencia, Spain, 46010
- Recruiting
- Clinical Study Site
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Valladolid, Spain, 47003
- Recruiting
- Clinical Study Site
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Zaragoza, Spain, 50009
- Recruiting
- Clinical Study Site
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Bizkaia
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Barakaldo, Bizkaia, Spain, 48903
- Recruiting
- Clinical Study Site
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Cantabria
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Santander, Cantabria, Spain, 39008
- Recruiting
- Clinical Study Site
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Extremadura
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Badajoz, Extremadura, Spain, 06080
- Recruiting
- Clinical Study Site
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Las Palmas
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Las Palmas, Las Palmas, Spain, 35016
- Recruiting
- Clinical Study Site
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Madrid
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Madrid, Madrid, Spain, 28040
- Recruiting
- Clinical Study Site
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Madrid, Madrid, Spain, 28007
- Recruiting
- Clinical Study Site
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Sevilla, Madrid, Spain, 41014
- Recruiting
- Clinical Study Site
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Malaga
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Marbella, Malaga, Spain, 29660
- Recruiting
- Clinical Study Site
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Martin Lagos
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Madrid, Martin Lagos, Spain, 28040
- Recruiting
- Clinical Study Site
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Seville
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Seville, Seville, Spain, 41009
- Recruiting
- Clinical Study Site
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Spain
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Barcelona, Spain, Spain, 08003
- Recruiting
- Clinical Study Site
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Barcelona, Spain, Spain, 08908
- Recruiting
- Clinical Study Site
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Madrid, Spain, Spain, 28034
- Recruiting
- Clinical Study Site
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Madrid, Spain, Spain, 28041
- Recruiting
- Clinical Study Site
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Adana, Turkey (Türkiye), 01230
- Recruiting
- Clinical Study Site
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Ankara, Turkey (Türkiye), 06520
- Recruiting
- Clinical Study Site
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Ankara, Turkey (Türkiye), 06010
- Recruiting
- Clinical Study Site
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Ankara, Turkey (Türkiye), 06230
- Recruiting
- Clinical Study Site
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Ankara, Turkey (Türkiye), 06590
- Recruiting
- Clinical Study Site
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Antalya, Turkey (Türkiye), 07059
- Recruiting
- Clinical Study Site
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Diyarbakır, Turkey (Türkiye), 21280
- Recruiting
- Clinical Study Site
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Gaziantep, Turkey (Türkiye), 27060
- Recruiting
- Clinical Study Site
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Istanbul, Turkey (Türkiye), 34722
- Recruiting
- Clinical Study Site
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Contact:
- Clinical Study Site Clinical Study Site
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Istanbul, Turkey (Türkiye), 34460
- Recruiting
- Clinical Study Site
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Istanbul, Turkey (Türkiye), 34098
- Recruiting
- Clinical Study Site
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Izmir, Turkey (Türkiye), 35100
- Recruiting
- Clinical Study Site
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Konya, Turkey (Türkiye), 42080
- Recruiting
- Clinical Study Site
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Seyhan, Turkey (Türkiye), 01140
- Recruiting
- Clinical Study Site
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İzmit, Turkey (Türkiye), 41380
- Recruiting
- Clinical Study Site
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Bahcelievler
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Istanbul, Bahcelievler, Turkey (Türkiye), 34180
- Recruiting
- Clinical Study Site
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Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye), 06200
- Recruiting
- Clinical Study Site
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Arizona
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Chandler, Arizona, United States, 85224
- Recruiting
- Clinical Study Site
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Phoenix, Arizona, United States, 85006
- Recruiting
- Clinical Study Site
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Recruiting
- Clinical Study Site
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Jonesboro, Arkansas, United States, 72401
- Recruiting
- Clinical Study Sites
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California
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Alameda, California, United States, 90720
- Recruiting
- Clinical Study Site
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Anaheim, California, United States, 92805
- Recruiting
- Clinical Study Site
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Beverly Hills, California, United States, 90211
- Recruiting
- Clinical Study Site
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Cerritos, California, United States, 90703
- Recruiting
- Clinical Study Site
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Los Angeles, California, United States, 90067
- Recruiting
- Clinical Study Site
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Los Angeles, California, United States, 90034
- Recruiting
- Clinical Study Site
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Orange, California, United States, 92868
- Recruiting
- Clinical Study Site
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Oxnard, California, United States, 93030
- Recruiting
- Clinical Study Site
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San Diego, California, United States, 92123
- Recruiting
- Clinical Study Site
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Sunnyvale, California, United States, 94086
- Recruiting
- Clinical Study Site
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Torrance, California, United States, 90505
- Recruiting
- Clinical Study Site
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Clinical Study Site
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Denver, Colorado, United States, 80210
- Recruiting
- Clinical Study Site
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Grand Junction, Colorado, United States, 81505
- Recruiting
- Clinical Study Site
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Lone Tree, Colorado, United States, 80124
- Recruiting
- Clinical Study Site
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Loveland, Colorado, United States, 80538
- Recruiting
- Clinical Study Site
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Florida
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Fort Lauderdale, Florida, United States, 33317
- Recruiting
- Clinical Study Site
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Fort Lauderdale, Florida, United States, 33308
- Recruiting
- Clinical Study Sites
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Jacksonville, Florida, United States, 32207
- Recruiting
- Clinical Study Site
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Jacksonville Beach, Florida, United States, 32256
- Recruiting
- Clinical Study Site
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North Venice, Florida, United States, 34275
- Recruiting
- Clinical Study Site
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Orlando, Florida, United States, 32822
- Recruiting
- Clinical Study Site
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Contact:
- Site
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Pensacola, Florida, United States, 32504
- Recruiting
- Clinical Study Site
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Plantation, Florida, United States, 33323
- Recruiting
- Clinical Study Site
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Tallahassee, Florida, United States, 32308
- Recruiting
- Clinical Study Site
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Tamarac, Florida, United States, 33321
- Recruiting
- Clinical Study Site
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West Palm Beach, Florida, United States, 33401
- Recruiting
- Clinical Study Site
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Georgia
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Atlanta, Georgia, United States, 30318
- Recruiting
- Clinical Study Site
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Warner Robins, Georgia, United States, 31088
- Recruiting
- Clinical Study Site
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Illinois
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Carterville, Illinois, United States, 62918
- Recruiting
- Clinical Study Site
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Chicago, Illinois, United States, 60611
- Recruiting
- Clinical Study Site
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Chicago, Illinois, United States, 60612
- Recruiting
- Clinical Study Site
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Evanston, Illinois, United States, 60201
- Recruiting
- Clinical Study Site
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Indiana
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Indianapolis, Indiana, United States, 46237
- Recruiting
- Clinical Study Site
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Iowa
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Waukee, Iowa, United States, 50263
- Recruiting
- Clinical Study Site
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Kentucky
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Lexington, Kentucky, United States, 40503
- Recruiting
- Clinical Study Site
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Contact:
- Site
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Louisiana
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Covington, Louisiana, United States, 70433
- Recruiting
- Clinical Study Site
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Maryland
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Baltimore, Maryland, United States, 21229
- Recruiting
- Clinical Study Site
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Clinical Study Site
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Brighton, Massachusetts, United States, 21350
- Recruiting
- Clinical Study Site
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Foxborough, Massachusetts, United States, 02035
- Recruiting
- Clinical Study Site
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Methuen, Massachusetts, United States, 01844
- Recruiting
- Clinical Study Site
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Milford, Massachusetts, United States, 01757
- Recruiting
- Clinical Study Site
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Weymouth, Massachusetts, United States, 02190
- Recruiting
- Clinical Study Site
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Worcester, Massachusetts, United States, 01655
- Recruiting
- Clinical Study Site
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- Clinical Study Site
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Detroit, Michigan, United States, 48202
- Recruiting
- Clinical Study Sites
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Detroit, Michigan, United States, 48201
- Recruiting
- Clinical Study Site
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Minnesota
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Duluth, Minnesota, United States, 55805
- Recruiting
- Clinical Study Sites
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- Clinical Study Site
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Saint Paul, Minnesota, United States, 55101
- Recruiting
- Clinical Study Site
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Mississippi
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Hattiesburg, Mississippi, United States, 39401
- Recruiting
- Clinical Study Site
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Missouri
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Kansas City, Missouri, United States, 64132
- Recruiting
- Clinical Study Site
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St Louis, Missouri, United States, 63128
- Recruiting
- Clinical Study Site
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St Louis, Missouri, United States, 63141
- Recruiting
- Clinical Study Site
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Recruiting
- Clinical Study Site
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New Jersey
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Mullica Hill, New Jersey, United States, 08062
- Recruiting
- Clinical Study Site
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New Brunswick, New Jersey, United States, 08901
- Recruiting
- Clinical Study Site
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New York
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New York, New York, United States, 10065
- Recruiting
- Clinical Study Site
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Syracuse, New York, United States, 13210
- Recruiting
- Clinical Study Site
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Contact:
- Clinical Study Site Clinical Study Site
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The Bronx, New York, United States, 10461
- Recruiting
- Clinical Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Recruiting
- Clinical Study Site
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Durham, North Carolina, United States, 27708
- Recruiting
- Clinical Study Site
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Pinehurst, North Carolina, United States, 28374
- Recruiting
- Clinical Study Site
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Ohio
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Cincinnati, Ohio, United States, 45220
- Recruiting
- Clinical Study Sites
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Cleveland, Ohio, United States, 44195
- Recruiting
- Clinical Study Site
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Columbus, Ohio, United States, 43219
- Recruiting
- Clinical Study Site
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Columbus, Ohio, United States, 43210
- Recruiting
- Clinical Study Sites
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73102
- Recruiting
- Clinical Study Site
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Oregon
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Eugene, Oregon, United States, 97401
- Recruiting
- Clinical Study Site
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Portland, Oregon, United States, 97239
- Recruiting
- Clinical Study Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Recruiting
- Clinical Study Site
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- Clinical Study Site
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Tennessee
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Nashville, Tennessee, United States, 37235
- Recruiting
- Clinical Study Site
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Nashville, Tennessee, United States, 37203
- Recruiting
- Clinical Study Sites
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Texas
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Abilene, Texas, United States, 79601
- Recruiting
- Clinical Study Site
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Austin, Texas, United States, 78745
- Recruiting
- Clinical Study Site
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Dallas, Texas, United States, 75246
- Recruiting
- Clinical Study Site
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Fort Worth, Texas, United States, 76104
- Recruiting
- Clinical Study Site
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Houston, Texas, United States, 77030
- Recruiting
- Clinical Study Site
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Tyler, Texas, United States, 75708
- Recruiting
- Clinical Study Site
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Webster, Texas, United States, 77598
- Recruiting
- Clinical Study Site
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Utah
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Salt Lake City, Utah, United States, 84106
- Recruiting
- Clinical Study Site
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Virginia
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Blacksburg, Virginia, United States, 24061
- Recruiting
- Clinical Study Site
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Charlottesville, Virginia, United States, 22908
- Recruiting
- Clinical Study Site
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Fairfax, Virginia, United States, 22031
- Recruiting
- Clinical Study Site
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Richmond, Virginia, United States, 23229
- Recruiting
- Clinical Study Site
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Richmond, Virginia, United States, 23298
- Recruiting
- Clinical Study Site
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Washington
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Seattle, Washington, United States, 98109
- Recruiting
- Clinical Study Site
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Vancouver, Washington, United States, 98684
- Recruiting
- Clinical Study Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm A - Ivonescimab
Subject will receive ivonescimab as an IV injection
|
Subject will receive ivonescimab as an IV injection
|
|
Active Comparator: Arm B - Pembrolizumab
Subject will receive pembrolizumab as an IV injection
|
Subject will receive Pembrolizumab as an IV injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival (OS)
Time Frame: Up to approximately 36 months
|
Up to approximately 36 months
|
|
Progression free survival (PFS)
Time Frame: Up to approximately 36 months
|
Up to approximately 36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective response rate (ORR)
Time Frame: Up to approximately 36 months
|
Up to approximately 36 months
|
|
Disease control rate ( DCR)
Time Frame: Up to approximately 36 months
|
Up to approximately 36 months
|
|
Duration of response (DoR)
Time Frame: Up to approximately 36 months
|
Up to approximately 36 months
|
|
Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Time Frame: [Time Frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, Up to approximately 24 months.
|
[Time Frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, Up to approximately 24 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: United States California, Summit Therapeutics Research Center, Santa Rosa, California, Unites States 95403
- Principal Investigator: United States California, Summit Therapeutics Research Center, Los Angeles, California, United States 90067
- Principal Investigator: United States California, Summit Therapeutics Research Center, Irvine, California, United States 92868
- Principal Investigator: United States Florida, Summit Therapeutics Research Center, Fort Lauderdale, Florida, United States, 33016
- Principal Investigator: United States New York, Summit Therapeutics Research Center, NewYork, United States 10021
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
June 1, 2029
Study Registration Dates
First Submitted
January 3, 2025
First Submitted That Met QC Criteria
January 8, 2025
First Posted (Actual)
January 10, 2025
Study Record Updates
Last Update Posted (Actual)
August 19, 2026
Last Update Submitted That Met QC Criteria
August 18, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- pembrolizumab
Other Study ID Numbers
- SMT112-3007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.