Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06767514

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

Led by Summit Therapeutics · Updated on 2026-02-24

780

Participants Needed

202

Research Sites

222 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years old at the time of enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
  • Expected life expectancy 65 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.
Not Eligible

You will not qualify if you...

  • Presence of small cell lung carcinoma or evidence of it requiring first-line approved therapies
  • Prior therapy for metastatic NSCLC
  • Concurrent enrollment in another interventional clinical study
  • Known actionable genomic alterations requiring first-line approved therapies
  • Symptomatic CNS metastases, CNS metastasis 65 1.5 cm, recent CNS radiation within 7 days, potential need for CNS radiation in first cycle, or leptomeningeal disease
  • Other prior malignancy unless curative therapy with no recurrence for 3 years
  • Active autoimmune or lung disease requiring systemic therapy
  • Pre-existing peripheral neuropathy 65 Grade 2 by CTCAE version 5
  • Severe infection within 4 weeks prior to randomization
  • Major surgery or serious trauma within 4 weeks prior to randomization
  • History of noninfectious pneumonia requiring systemic corticosteroids or current interstitial lung disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 202 locations

1

Clinical Study Site

Chandler, Arizona, United States, 85224

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2

Clinical Study Site

Phoenix, Arizona, United States, 85006

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3

Clinical Study Site

Hot Springs, Arkansas, United States, 71913

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4

Clinical Study Site

Cerritos, California, United States, 90703

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5

Clinical Study Site

Glendale, California, United States, 91204

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6

Clinical Study Site

Irvine, California, United States, 92612

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7

Clinical Study Site

Los Angeles, California, United States, 90067

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8

Clinical Study Site

Mountain View, California, United States, 94040

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9

Clinical Study Site

Murrieta, California, United States, 92562

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10

Clinical Study Site

Newport Beach, California, United States, 92663

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11

Clinical Study Site

Roseville, California, United States, 95661

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12

Clinical Study Site

Sacramento, California, United States, 95816

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13

Clinical Study Site

San Diego, California, United States, 92123

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14

Clinical Study Site

San Francisco, California, United States, 94115

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15

Clinical Study Site

Santa Ana, California, United States, 92705

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16

Clinical Study Site

Whittier, California, United States, 90602

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17

Clinical Study Site

Aurora, Colorado, United States, 80045

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18

Clinical Study Site

Grand Junction, Colorado, United States, 81505

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19

Clinical Study Site

Greeley, Colorado, United States, 80631

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20

Clinical Study Site

Lone Tree, Colorado, United States, 80124

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21

Clinical Study Site

Loveland, Colorado, United States, 80538

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22

Clinical Study Site

Fort Lauderdale, Florida, United States, 33317

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23

Clinical Study Site

Hialeah, Florida, United States, 33013

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24

Clinical Study Site

Jacksonville, Florida, United States, 32256

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25

Clinical Study Site

Miami, Florida, United States, 33155

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26

Clinical Study Site

North Venice, Florida, United States, 34275

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27

Clinical Study Site

Orlando, Florida, United States, 32822

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28

Clinical Study Site

Pensacola, Florida, United States, 32504

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29

Clinical Study Site

Plantation, Florida, United States, 33322

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30

Clinical Study Site

Plantation, Florida, United States, 33323

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31

Clinical Study Site

Tallahassee, Florida, United States, 32308

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32

Clinical Study Site

Tamarac, Florida, United States, 33321

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33

Clinical Study Site

West Palm Beach, Florida, United States, 33401

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34

Clinical Study Site

Atlanta, Georgia, United States, 30318

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35

Clinical Study Site

Macon, Georgia, United States, 30318

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36

Clinical Study Site

Macon, Georgia, United States, 31210

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37

Clinical Study Site

Carterville, Illinois, United States, 62918

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38

Clinical Study Site

Indianapolis, Indiana, United States, 46237

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39

Clinical Study Site

Waukee, Iowa, United States, 50263

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40

Clinical Study Site

Lexington, Kentucky, United States, 40503

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41

Clinical Study Site

Covington, Louisiana, United States, 70433

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42

Clinical Study Site

Baltimore, Maryland, United States, 21229

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43

Clinical Study Site

Boston, Massachusetts, United States, 02215

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44

Clinical Study Site

Milton, Massachusetts, United States, 02186

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45

Clinical Study Site

Worcester, Massachusetts, United States, 01655

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46

Clinical Study Sites

Detroit, Michigan, United States, 48202

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47

Clinical Study Site

Detroit, Michigan, United States, 48202

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48

Clinical Study Site

Lansing, Michigan, United States, 48910

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49

Clinical Study Site

Minneapolis, Minnesota, United States, 55455

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50

Clinical Study Site

Saint Louis Park, Minnesota, United States, 55426

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51

Clinical Study Site

Saint Paul, Minnesota, United States, 55101

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52

Clinical Study Site

Hattiesburg, Mississippi, United States, 39401

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53

Clinical Study Site

Kansas City, Missouri, United States, 64132

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54

Clinical Study Site

St Louis, Missouri, United States, 63128

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55

Clinical Study Site

Lebanon, New Hampshire, United States, 03756

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56

Clinical Study Site

Basking Ridge, New Jersey, United States, 07920

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57

Clinical Study Site

Middletown, New Jersey, United States, 07748

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58

Clinical Study Site

Montvale, New Jersey, United States, 07645

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59

Clinical Study Site

Mullica Hill, New Jersey, United States, 08062

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60

Clinical Study Site

New Brunswick, New Jersey, United States, 08901

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61

Clinical Study Site

Glen Falls, New York, United States, 12801

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62

Clinical Study Site

Harrison, New York, United States, 10604

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63

Clinical Study Site

New York, New York, United States, 10065

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64

Clinical Study Site

Syracuse, New York, United States, 13210

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65

Clinical Study Site

Uniondale, New York, United States, 11553

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66

Clinical Study Site

Chapel Hill, North Carolina, United States, 27592

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67

Clinical Study Site

Columbus, Ohio, United States, 43219

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68

Clinical Study Sites

Lebanon, Ohio, United States, 45036

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69

Clinical Study Site

Oklahoma City, Oklahoma, United States, 73102

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70

Clinical Study Site

Eugene, Oregon, United States, 97401

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71

Clinical Study Site

Portland, Oregon, United States, 97239

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72

Clinical Study Site

Philadelphia, Pennsylvania, United States, 19111

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73

Clinical Study Site

Pittsburgh, Pennsylvania, United States, 15232

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74

Clinical Study Site

Nashville, Tennessee, United States, 37235

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75

Clinical Study Site

Abilene, Texas, United States, 79601

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76

Clinical Study Site

Austin, Texas, United States, 78745

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77

Clinical Study Site

Dallas, Texas, United States, 75246

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78

Clinical Study Site

Forth Worth, Texas, United States, 76104

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79

Clinical Study Site

Houston, Texas, United States, 77030

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80

Clinical Study Site

Tyler, Texas, United States, 75708

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81

Clinical Study Site

Webster, Texas, United States, 77598

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82

Clinical Study Site

Salt Lake City, Utah, United States, 84106

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83

Clinical Study Site

Blacksburg, Virginia, United States, 24060

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84

Clinical Study Site

Charlottesville, Virginia, United States, 22908

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85

Clinical Study Site

Fairfax, Virginia, United States, 22031

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86

Clinical Study Site

Richmond, Virginia, United States, 23229

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87

Clinical Study Site

Richmond, Virginia, United States, 23298

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88

Clinical Study Site

Seattle, Washington, United States, 98109

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89

Clinical Study Site

Vancouver, Washington, United States, 98684

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90

Clinical Study Site

Edmonton, Alberta, Canada, T6G 1Z2

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91

Clinical Study Site

London, Ontario, Canada, N6A 5W9

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92

Clinical Study Site

Montreal, Quebec, Canada, H3T 1E2

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93

Clinical Study Site

Montreal, Canada, H3T 1E2

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94

Clinical Study Site

Fuzhou, Fujian, China

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95

Clinical Study Site

Guangzhou, Guangdong, China

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96

Clinical Study Site

Haikou, Hainan, China

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97

Clinical Study Site

Harbin, Heilongjiang, China, 150081

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98

Clinical Site Study

Changzhou, Jiangsu, China

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99

Clinical Study Site

Ganzhou, Jiangxi, China

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100

Clinical Study Site

Nanchang, Jiangxi, China

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101

Clinical Study Site

Tai’an, Shandong, China

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102

Clinical Study Site

Weifang, Shandong, China

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103

Clinical Study Site

Shanghai, Shanghai Municipality, China

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104

Clinical Study Site

Kunming, Yunnan, China

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105

Clinical Study Site

Hangzhou, Zhejiang, China

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106

Clinical Study Site

Taizhou, Zhejiang, China

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107

Clinical Site Study

Wenzhou, Zhejiang, China

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108

Clinical Study Site

Changchun, China

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109

Clinical Study Site

Guangzhou, China

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110

Clinical Study Site

Xi'an, China

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111

Clinical Study Site

Nantes, Pays de Loire, France, 44277

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112

Clinical Study Site

Brest, France, 29200

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113

Clinical Study Site

Créteil, France, 94010

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114

Clinical Study Site

Lyon, France, 69008

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115

Clinical Study Site

Marseille, France, 13000

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116

Clinical Study Site

Paris, France, 75020

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117

Clinical Study Site

Rennes, France, 35033

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118

Clinical Study Site

Villejuif, France, 94800

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119

Clinical Study Site

Chemnitz, Germany, 91116

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120

Clinical Study Site

Gauting, Germany, 82131

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121

Clinical Study Site

Giesen, Germany, 35392

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122

Clinical Study Site

Karlsruhe, Germany, 76137

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123

Clinical Study Site

Minden, Germany, 32429

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124

Clinical Study Site

Moers, Germany, 47441

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125

Clinical Study Site

Möser, Germany, 47441

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126

Clinical Study Site

Athens, Greece, 15562

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127

Clinical Study Site

Rio, Greece, 26504

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128

Clinical Study Site

Thessaloniki, Greece, 546 22

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129

Clinical Study Site

Budapest, Hungary, 01121

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130

Clinical Study Site

Kecskemét, Hungary, 6000

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131

Clinical Study Site

Bari, Italy, 70124

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132

Clinical Study Site

Milan, Italy, 20037

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133

Clinical Study Site

Milan, Italy, 20141

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134

Clinical Study Site

Orbassano, Italy, 10043

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135

Clinical Study Site

Parma, Italy, 43126

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136

Clinical Study Site

Roma, Italy, 00144

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137

Clinical Study Site

Asahikawa, Hokkaido, Japan, 078-8510

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138

Clinical Study Site

Nishinomiya, Hyōgo, Japan, 663-8501

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139

Clinical Study Site

Matsusaka, Mie-ken, Japan, 515-8544

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140

Clinical Study Site

Sendai, Miyagi, Japan, 980-8574

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141

Clinical Study Site

Omura-shi, Nagasaki, Japan, 856-8562

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142

Clinical Study Site

Hirakata, Osaka, Japan, 573-1191

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143

Clinical Study Site

Osaka, Osaka, Japan, 541-8567

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144

Clinical Study Site

Hidaka, Saitama, Japan, 350-1298

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145

Clinical Study Site

Shimotsuke, Tochigi, Japan, 329-0498

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146

Clinical Study Site

Bunkyō-Ku, Tokyo, Japan, 113-8677

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147

Clinical Study Site

Koto-Ku, Tokyo, Japan, 135-8550

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148

Clinical Study Site

Wakayama, Wakayama, Japan, 641-8510

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149

Clinical Study Site

Kanazawa, Japan, 920-8641

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150

Clinical Study Site

Kumamoto, Japan, 861-4193

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151

Clinical Study Site

Kurume, Japan, 830-0011

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152

Clinical Study Site

Nagoya, Japan, 460-0001

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153

Clinical Study Site

Okayama, Japan, 700-8558

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154

Clinical Study Site

Sakai, Japan, 591-8555

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155

Clinical Study Site

Tokyo, Japan, 104-0045

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156

Clinical Study Site

Guadalajara, Mexico, 44670

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157

Clinical Study Site

Mexico City, Mexico, 06700

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158

Clinical Study Site

Monterrey, Mexico, 64710

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159

Clinical Study Site

Veracruz, Mexico, 91900

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160

Clinical Study Site

Gdansk, Poland, 80214

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161

Clinical Study Site

Lodz, Poland, 93338

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162

Clinical Study Site

Lublin, Poland, 20064

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163

Clinical Study Site

Poznan, Poland, 60-693

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164

Clinical Study Site

Skorzewo, Poland, 60185

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165

Clinical Study Site

Braga, Portugal, 4710-243

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166

Clinical Study Site

Coimbra, Portugal, 3020-479

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167

Clinical Study Site

Faro, Portugal, 8000-386

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168

Clinical Study Site

Porto, Portugal, 4099-001

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169

Clinical Study Site

Suceagu, Cluj, Romania, 407062

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170

Clinical Study Site

Baia Mare, Romania, 430031

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171

Clinical Study Site

Bucharest, Romania, 22328

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172

Clinical Study Site

Cluj-Napoca, Romania, 407062

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173

Clinical Study Site

Cluj-Napoca, Romania, 407280

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174

Clinical Study Site

Craiova, Romania, 200542

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175

Clinical Study Site

Iași, Romania, 700106

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176

Clinical Study Site

Ovidiu, Romania, 905900

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177

Clinical Study Site

Timișoara, Romania, 300166

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178

Clinical Study Site

Belgrade, Serbia, 11040

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179

Clinical Study Site

Belgrade, Serbia, 11080

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180

Clinical Study Site

Kragujevac, Serbia, 34000

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181

Clinical Study Site

Novi Sad, Serbia, 21204

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182

Clinical Study Site

Badajoz, Spain, 06080

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183

Clinical Study Site

Badalona, Spain, 08916

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184

Clinical Study Site

Barcelona, Spain, 08003

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185

Clinical Study Site

Girona, Spain, 17007

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186

Clinical Study Site

Las Palmas, Spain, 35016

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187

Clinical Study Site

Lugo, Spain, 27002

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188

Clinical Study Site

Madrid, Spain, 28040

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189

Clinical Study Site

Málaga, Spain, 29011

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190

Clinical Study Site

Seville, Spain, 41014

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191

Clinical Study Site

Valencia, Spain, 46026

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192

Clinical Study Site

Zaragoza, Spain, 50009

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193

Clinical Study Site

Adana, Turkey (Türkiye), 01140

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194

Clinical Study Site

Ankara, Turkey (Türkiye), 06520

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195

Clinical Study Site

Antalya, Turkey (Türkiye), 07059

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196

Clinical Study Site

Diyarbakır, Turkey (Türkiye), 21280

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197

Clinical Study Site

Gaziantep, Turkey (Türkiye), 27060

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198

Clinical Study Site

Istanbul, Turkey (Türkiye), 34460

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199

Clinical Study Site

Istanbul, Turkey (Türkiye), 34722

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200

Clinical Study Site

İzmit, Turkey (Türkiye), 41380

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201

Clinical Study Site

Konya, Turkey (Türkiye), 42080

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202

Clinical Study Site

Seyhan, Turkey (Türkiye), 07059

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Research Team

S

Summit Clinical Trial Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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