New drug rilvegostomig takes on keytruda in lung cancer showdown

NCT ID NCT06692738

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This phase 3 study compares two immunotherapy drugs—rilvegostomig and pembrolizumab (Keytruda)—each combined with standard chemotherapy, as a first treatment for people with advanced squamous non-small cell lung cancer that has a specific protein (PD-L1). About 880 participants worldwide will be randomly assigned to one of the two combinations. The goal is to see which drug helps people live longer or keeps the cancer from growing for a longer time.

What this could mean

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

Active substance: rilvegostomig (also called AZD2936) and pembrolizumab (Keytruda), both given with standard chemotherapy
What this could lead to: If rilvegostomig works better than pembrolizumab, it could offer a new first-line treatment option for people with this type of advanced lung cancer.
What could go wrong: This is a large phase 3 trial, but it's still experimental. Rilvegostomig may not prove superior to the already approved pembrolizumab, and side effects from combining it with chemotherapy could be significant.

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 1,160 people

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

Started

Nov 2024

Expected to finish

Jul 2030

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: * Histologically or cytologically documented squamous NSCLC. * Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available targeted 1L therapies. * Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements. * Adequate organ and bone marrow function. Exclusion Criteria: * Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization. * Any prior systemic, non-curative therapy received for NSCLC. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. * Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs. * Active primary immunodeficiency/active infectious disease(s). * Active tuberculosis infection.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic squamous non-small cell lung cancer are added.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma non-small cell squamous 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

292 sites in 25 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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Tucson, Arizona, 85724, United States
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Springdale, Arkansas, 72762, United States
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Anaheim, California, 92801, United States
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Beverly Hills, California, 90211, United States
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Loma Linda, California, 92354, United States
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Los Alamitos, California, 90720, United States
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Redlands, California, 92373, United States
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San Francisco, California, 94121, United States
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Walnut Creek, California, 94598, United States
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West Haven, Connecticut, 06516, United States
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Newark, Delaware, 19713, United States
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Bay Pines, Florida, 33744, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32608, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32224, United States
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Athens, Georgia, 30607, United States
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Atlanta, Georgia, 30341, United States
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Savannah, Georgia, 31404, United States
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Boise, Idaho, 83712, United States
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Chicago, Illinois, 60637, United States
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Decatur, Illinois, 62526, United States
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Hinsdale, Illinois, 60521, United States
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Quincy, Illinois, 62301, United States
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Rockford, Illinois, 61114, United States
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Fort Wayne, Indiana, 46845, United States
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Waterloo, Iowa, 50702, United States
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Lexington, Kentucky, 40509, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40207, United States
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Alexandria, Louisiana, 71301, United States
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Baton Rouge, Louisiana, 70808, United States
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Covington, Louisiana, 70433, United States
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Shreveport, Louisiana, 71103, United States
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Shreveport, Louisiana, 71105, United States
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Scarborough, Maine, 04074, United States
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Baltimore, Maryland, 21202, United States
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Bethesda, Maryland, 20817, United States
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Bethesda, Maryland, 20889, United States
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Detroit, Michigan, 48202, United States
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Grand Rapids, Michigan, 49503, United States
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Saginaw, Michigan, 48602, United States
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Duluth, Minnesota, 55802, United States
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Rochester, Minnesota, 55905, United States
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Bridgeton, Missouri, 63044, United States
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Columbia, Missouri, 65212, United States
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Kansas City, Missouri, 64108, United States
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Lincoln, Nebraska, 68506, United States
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Camden, New Jersey, 08103, United States
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Buffalo, New York, 14221, United States
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East Syracuse, New York, 13057, United States
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Westbury, New York, 11590, United States
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Wilson, North Carolina, 27893, United States
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Grand Forks, North Dakota, 58201, United States
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Cincinnati, Ohio, 45267, United States
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Bend, Oregon, 97701, United States
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Medford, Oregon, 97504, United States
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Salem, Oregon, 97301, United States
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Hershey, Pennsylvania, 17033, United States
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York, Pennsylvania, 17403, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77090, United States
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Kingwood, Texas, 77339, United States
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Lubbock, Texas, 79410, United States
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Round Rock, Texas, 78665, United States
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Fairfax, Virginia, 22031, United States
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Fredericksburg, Virginia, 22408, United States
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Olympia, Washington, 98506, United States
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Seattle, Washington, 98101, United States
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Silverdale, Washington, 98383, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Buenos Aires, C1431FWO, Argentina
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CABA, 1425, Argentina
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La Plata, 1900, Argentina
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Pilar, B1629ODT, Argentina
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Rosario, S2000DEJ, Argentina
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Darlinghurst, 2010, Australia
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Hyde Park, 4812, Australia
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Southport, 4215, Australia
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Wollongong, 2500, Australia
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Innsbruck, 6020, Austria
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Krems, 3500, Austria
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Rankweil, 6830, Austria
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Vienna, 1160, Austria
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Vienna, 1210, Austria
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Anderlecht, 1070, Belgium
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Brussels, 1160, Belgium
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Charleroi, 6060, Belgium
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Kortrijk, 8500, Belgium
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Ottignies, 1340, Belgium
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Sint-Niklaas, 9100, Belgium
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Ijuí, 98700-000, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40050 410, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 05652-900, Brazil
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Taubaté, 12030-200, Brazil
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Saint John, New Brunswick, E2L 4L2, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Hamilton, Ontario, L8V 1C3, Canada
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Sault Ste. Marie, Ontario, P6A 0A8, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100021, China
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Beijing, 100029, China
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Beijing, 100142, China
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Beijing, 101149, China
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Beijing, CN-100730, China
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Changchun, 130012, China
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Changde, 415000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400030, China
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Dalian, 116001, China
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Guangzhou, 510062, China
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Guangzhou, 510100, China
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Hangzhou, 310003, China
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Hangzhou, 310016, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Hefei, 230601, China
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Jinan, 250117, China
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Kunming, 650118, China
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Linhai, 317000, China
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Linyi, 276001, China
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Nanchang, 330008, China
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Ningbo, 315010, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Shenyang, 110004, China
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Shenzhen, 518020, China
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Taiyuan, 030000, China
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Tianjin, 300050, China
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Wenzhou, CN-325000, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Yangzhou, 225001, China
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Yueyang, 414000, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Avignon, 84902, France
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La Rochelle, 17019, France
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Lyon, 69008, France
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Nîmes, 30029, France
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Rennes, 35033, France
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Strasbourg, 67091, France
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Suresnes, 92150, France
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Toulon, 83800, France
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Bad Berka, 99437, Germany
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Berlin, 13125, Germany
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Berlin, 13585, Germany
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Bielefeld, 33611, Germany
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Bochum, 44791, Germany
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Chemnitz, 09116, Germany
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Cologne, 51109, Germany
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Essen, 45136, Germany
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Esslingen am Neckar, 73730, Germany
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Frankfurt, 60488, Germany
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Frankfurt am Main, 60431, Germany
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Gauting, 82131, Germany
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Giessen, 35392, Germany
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Großhansdorf, 22927, Germany
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Halle, 06120, Germany
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Hamburg, 20251, Germany
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Hanover, 30459, Germany
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Hanover, 30625, Germany
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Heidelberg, 69126, Germany
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Hemer, 58675, Germany
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Homburg, 66424, Germany
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Kassel, 34125, Germany
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Kiel, 24105, Germany
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Krefeld, 47805, Germany
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Magdeburg, 39120, Germany
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Minden, 32429, Germany
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Moers, 47441, Germany
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München, 81925, Germany
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Regensburg, 93053, Germany
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Schwerin, 19049, Germany
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Velbert, 42551, Germany
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Würzburg, 97067, Germany
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Edelény, 3780, Hungary
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Gyöngyös, 3200, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Győr, 9024, Hungary
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Pécs, 7624, Hungary
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Székesfehérvár, 8000, Hungary
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Törökbálint, 2045, Hungary
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Calicut, 673601, India
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Delhi, 110029, India
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Gurgaon, 122001, India
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Kolkata, 700054, India
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Madurai, 625107, India
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Mumbai, 400012, India
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Nashik, 422002, India
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New Delhi, 110075, India
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Puducherry, 605006, India
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Surat, 395017, India
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Varanasi, 221005, India
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Florence, 50134, Italy
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Legnano, 20025, Italy
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Livorno, 57126, Italy
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Monza, 20900, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Peschiera del Garda, 37019, Italy
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Roma, 00168, Italy
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Amagasaki-shi, 660-8550, Japan
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Fukuoka, 814-0180, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 734-8551, Japan
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Kakogawa-shi, 675-8611, Japan
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Kanazawa, 920-8530, Japan
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Kawagoe-shi, 350-8550, Japan
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Kawasaki-shi, 216-8511, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kitakyushu-shi, 807-8555, Japan
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Kiyose-shi, 204-8522, Japan
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Kobe, 650-0017, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kumamoto, 861-4193, Japan
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Kyoto, 612-8555, Japan
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Matsusaka-shi, 515-8544, Japan
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Obihiro-shi, 080-0024, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Saitama-shi, 338-0001, Japan
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Sakai, 590-0197, Japan
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Sapporo, 006-8555, Japan
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Sendai, 981-0914, Japan
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Shinjuku-ku, 160-0023, Japan
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Takaoka-shi, 933-8555, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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George Town, 10450, Malaysia
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Johor Bahru, 81100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Alkmaar, 1815 JD, Netherlands
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Ede, 6716 RP, Netherlands
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Groningen, 9713 GZ, Netherlands
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Leidschendam, 2262 BA, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Zwolle, 8025 AB, Netherlands
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Lima, 15036, Peru
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Lima, 15102, Peru
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Lima, 34, Peru
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Lima, L27, Peru
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Lima, LIMA 29, Peru
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Lima, Lima39, Peru
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Bialystok, 15-027, Poland
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Biała Podlaska, 21-500, Poland
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Bydgoszcz, 85-796, Poland
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Bystra, 43-360, Poland
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Lodz, 93-338, Poland
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Lublin, 20-090, Poland
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Poznan, 60-569, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 53-413, Poland
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San Juan, 00909, Puerto Rico
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San Juan, 00918, Puerto Rico
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Changwon-si, 51353, South Korea
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Cheongju-si, 28644, South Korea
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Incheon, 21565, South Korea
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JinJoo, 52727, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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Barcelona, 8035, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Majadahonda, 28222, Spain
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Seville, 41013, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 824, Taiwan
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New Taipei City, 220, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 402, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 73657, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Dusit, 10300, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Songkhla, 90110, Thailand
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Ankara, 6500, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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RECRUITING

Yenimahalle, 06170, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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WITHDRAWN

Exeter, EX2 5DW, United Kingdom
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Greater London, SW3 6JJ, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE7 7AF, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Vinh, 460000, Vietnam

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