New lung cancer drug ivonescimab takes on pembrolizumab in major trial

NCT ID NCT06767514

Disease control Sponsor: Summit Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This phase 3 study compares ivonescimab, an experimental immunotherapy, to the standard drug pembrolizumab in 780 people with advanced non-small cell lung cancer that has high PD-L1 levels. Participants receive one of the two drugs as their first treatment. The study measures how long they live and how long their cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ivonescimab
What this could lead to: If ivonescimab works better than pembrolizumab, it could become a new first-line treatment option for people with advanced lung cancer whose tumors have high PD-L1 levels.
What could go wrong: This is a large phase 3 trial, but ivonescimab is still experimental. It may not prove superior to pembrolizumab, and side effects could be similar or worse. Results may not apply to all lung cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 780 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

285 sites in 17 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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The Bronx, New York, 10461, United States
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Changzhou, Jiangsu, China
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Wenzhou, Zhejiang, China
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Chandler, Arizona, 85224, United States
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Phoenix, Arizona, 85006, United States
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Hot Springs, Arkansas, 71913, United States
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Alameda, California, 90720, United States
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Anaheim, California, 92805, United States
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Beverly Hills, California, 90211, United States
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Cerritos, California, 90703, United States
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Los Angeles, California, 90034, United States
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Los Angeles, California, 90067, United States
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Orange, California, 92868, United States
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Oxnard, California, 93030, United States
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San Diego, California, 92123, United States
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Sunnyvale, California, 94086, United States
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Torrance, California, 90505, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80210, United States
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Grand Junction, Colorado, 81505, United States
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Lone Tree, Colorado, 80124, United States
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Loveland, Colorado, 80538, United States
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Fort Lauderdale, Florida, 33317, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville Beach, Florida, 32256, United States
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North Venice, Florida, 34275, United States
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Ocala, Florida, 34474, United States
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Orlando, Florida, 32822, United States
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Pensacola, Florida, 32504, United States
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Plantation, Florida, 33323, United States
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St. Petersburg, Florida, 33709, United States
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Tallahassee, Florida, 32308, United States
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Tamarac, Florida, 33321, United States
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West Palm Beach, Florida, 33401, United States
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Atlanta, Georgia, 30318, United States
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Warner Robins, Georgia, 31088, United States
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Carterville, Illinois, 62918, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Evanston, Illinois, 60201, United States
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Indianapolis, Indiana, 46237, United States
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Waukee, Iowa, 50263, United States
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Lexington, Kentucky, 40503, United States
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Covington, Louisiana, 70433, United States
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Baltimore, Maryland, 21229, United States
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Boston, Massachusetts, 02215, United States
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Brighton, Massachusetts, 21350, United States
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Foxborough, Massachusetts, 02035, United States
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Methuen, Massachusetts, 01844, United States
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Milford, Massachusetts, 01757, United States
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Weymouth, Massachusetts, 02190, United States
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Worcester, Massachusetts, 01655, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48201, United States
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Minneapolis, Minnesota, 55455, United States
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Saint Paul, Minnesota, 55101, United States
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Hattiesburg, Mississippi, 39401, United States
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Kansas City, Missouri, 64132, United States
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St Louis, Missouri, 63128, United States
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St Louis, Missouri, 63141, United States
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Lebanon, New Hampshire, 03756, United States
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Mullica Hill, New Jersey, 08062, United States
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New Brunswick, New Jersey, 08901, United States
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New York, New York, 10065, United States
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Syracuse, New York, 13210, United States
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Chapel Hill, North Carolina, 27514, United States
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Durham, North Carolina, 27708, United States
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Pinehurst, North Carolina, 28374, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43219, United States
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Oklahoma City, Oklahoma, 73102, United States
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Eugene, Oregon, 97401, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Greenville, South Carolina, 29605, United States
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Nashville, Tennessee, 37235, United States
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Abilene, Texas, 79601, United States
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Austin, Texas, 78745, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Tyler, Texas, 75708, United States
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Webster, Texas, 77598, United States
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Salt Lake City, Utah, 84106, United States
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Blacksburg, Virginia, 24061, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23229, United States
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Richmond, Virginia, 23298, United States
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Seattle, Washington, 98109, United States
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Vancouver, Washington, 98684, United States
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Mons, Hainaut, 07000, Belgium
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Charleroi, 09600, Belgium
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Ghent, 09000, Belgium
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Edmonton, Alberta, T6G 1Z2, Canada
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Etobicoke, Ontario, M9V 1R8, Canada
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London, Ontario, N6A 5W9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Fuyang, Anhui, China
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Beijing, Beijing Municipality, China
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Fuzhou, Fujian, China
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Guangzhou, Guangdong, China
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Nanning, Guangxi, China
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Guiyang, Guizhou, China
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Haikou, Hainan, China
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Harbin, Heilongjiang, 150081, China
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Luoyang, Henan, China
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Nanyang, Henan, China
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Zhengzhou, Henan, China
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Changsha, Hunan, China
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Zhuzhou, Hunan, China
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Hohhot, Inner Mongolia, China
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Ganzhou, Jiangxi, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Shenyang, Liaoning, China
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Jinan, Shandong, China
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Qingdao, Shandong, China
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Tai’an, Shandong, China
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Weifang, Shandong, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Luzhou, Sichuan, China
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Weihui, Xinxiang, 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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Beijing, China
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Shanghai, China
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Nantes, Pays de Loire, 44277, France
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Avignon, France
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Brest, 29200, France
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Créteil, 94010, France
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Lille, 59000, France
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Lyon, 69008, France
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Marseille, 13000, France
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Paris, 75020, France
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Paris, 75248, France
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Rennes, 35033, France
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Strasbourg, France
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Toulon, France
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Toulouse, France
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Villejuif, 94800, France
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Chemnitz, 09116, Germany
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Gauting, 82131, Germany
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Giesen, 35392, Germany
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Halle, 06120, Germany
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Herne, 44651, Germany
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Karlsruhe, 76137, Germany
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Minden, 32429, Germany
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Möser, 47441, Germany
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Athens, 10431, Greece
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Athens, 15562, Greece
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Rio, 26504, Greece
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Thessaloniki, 54622, Greece
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Budapest, 01121, Hungary
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Budapest, 01122, Hungary
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Gyöngyös, 03200, Hungary
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Gyula, 05700, Hungary
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Kecskemét, 06000, Hungary
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Rome, Italy, 00189, Italy
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Bari, 70124, Italy
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Bergamo, 24125, Italy
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Milan, 20037, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Parma, 43126, Italy
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Peschiera del Garda, 37019, Italy
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Rome, 00144, Italy
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Nagoya, Aichi-ken, 460-0001, Japan
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Kurume, Fukuoka, 830-0011, Japan
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Asahikawa, Hokkaido, 078-8510, Japan
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Nishinomiya, Hyōgo, 663-8501, Japan
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Kanazawa, Ishikawa-ken, 920-8641, Japan
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Tokyo, Japan, 104-0045, Japan
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Kumamoto, Kumamoto, 861-4193, Japan
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Matsusaka, Mie-ken, 515-8544, Japan
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Sendai, Miyagi, 980-8574, Japan
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Omura-shi, Nagasaki, 856-8562, Japan
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Okayama, Okayama-ken, 700-8558, Japan
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Hirakata, Osaka, 573-1191, Japan
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Osaka, Osaka, 541-8567, Japan
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Hidaka, Saitama, 350-1298, Japan
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Shimotsuke, Tochigi, 329-0498, Japan
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Bunkyō-Ku, Tokyo, 113-8677, Japan
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Koto-Ku, Tokyo, 135-8550, Japan
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Wakayama, Wakayama, 641-8510, Japan
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Sakai, 591-8555, Japan
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Aguascalientes, Aguascalientes, 20124, Mexico
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Querétaro, Mexico City, 76269, Mexico
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Oaxaca City, Oaxaca, 68020, Mexico
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Guadalajara, 44670, Mexico
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Guadalajara, 44680, Mexico
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Jalisco, 44680, Mexico
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Mexico City, 03240, Mexico
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Mexico City, 06700, Mexico
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Mexico City, 14080, Mexico
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Monterrey, 64710, Mexico
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Veracruz, 91900, Mexico
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Gdansk, 80214, Poland
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Lodz, 93338, Poland
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Lublin, 20064, Poland
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Poznan, 60693, Poland
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Skorzewo, 60185, Poland
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Braga, Braga District, 4710-243, Portugal
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Lisbon, Lisban, 1400-038, Portugal
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Porto, Portugal, 4200-072, Portugal
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Coimbra, 3020-479, Portugal
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Faro, 8000-386, Portugal
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Porto, 4099-001, Portugal
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Cluj-Napoca, Cluj, 400015, Romania
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Cluj-Napoca, Cluj, 400641, Romania
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Cluj-Napoca, Cluj, 407280, Romania
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Suceagu, Cluj, 407062, Romania
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Ovidiu, Constanța County, 905900, Romania
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Craiova, Dolj, 200542, Romania
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Iași, Iaşi, 700106, Romania
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Baia Mare, Maramureş, 430031, Romania
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Timișoara, Timiș County, 300166, Romania
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Timișoara, Timiș County, 300425, Romania
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Bucharest, 022328, Romania
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Belgrade, 11040, Serbia
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Belgrade, 11080, Serbia
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Kragujevac, 34000, Serbia
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Novi Sad, 21204, Serbia
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Barakaldo, Bizkaia, 48903, Spain
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Santander, Cantabria, 39008, Spain
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Badajoz, Extremadura, 06080, Spain
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Las Palmas, Las Palmas, 35016, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28040, Spain
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Sevilla, Madrid, 41014, Spain
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Marbella, Malaga, 29660, Spain
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Madrid, Martin Lagos, 28040, Spain
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Seville, Seville, 41009, Spain
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Barcelona, Spain, 08003, Spain
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Barcelona, Spain, 08908, Spain
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Madrid, Spain, 28034, Spain
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Madrid, Spain, 28041, Spain
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A Coruña, 15006, Spain
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Badalona, 08916, Spain
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Burgos, 09006, Spain
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Girona, 17007, Spain
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Lugo, 27002, Spain
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Málaga, 29011, Spain
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Seville, 41014, Spain
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Valencia, 46010, Spain
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Valencia, 46026, Spain
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Valladolid, 47003, Spain
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Zaragoza, 50009, Spain
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Istanbul, Bahcelievler, 34180, Turkey (Türkiye)
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Ankara, Yenimahalle, 06200, Turkey (Türkiye)
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Adana, 01230, Turkey (Türkiye)
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06520, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Gaziantep, 27060, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34460, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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İzmit, 41380, Turkey (Türkiye)
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Konya, 42080, Turkey (Türkiye)
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Seyhan, 01140, Turkey (Türkiye)
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Jonesboro, Arkansas, 72401, United States
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Fort Lauderdale, Florida, 33308, United States
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Detroit, Michigan, 48202, United States
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Duluth, Minnesota, 55805, United States
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Cincinnati, Ohio, 45220, United States
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Columbus, Ohio, 43210, United States
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Nashville, Tennessee, 37203, United States
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Tianjin, China
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Esslingen am Neckar, 73701, Germany
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Athens, 12462, Greece
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Athens, 18547, Greece
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Orbassano, 10043, Italy
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Kyoto, Kyoto, 602-8566, Japan
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Mexico City, 10200, Mexico
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Guadalajara, Jalisco, 44620, Mexico
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Aguascalientes, 20124, Mexico
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Veracruz, 20124, Mexico

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