New drug combo aims to keep stage III lung cancer in check
NCT ID NCT05211895
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study tests whether adding a second immunotherapy drug (domvanalimab) to the standard drug durvalumab can better control stage III lung cancer that hasn't grown after initial chemo-radiation. About 860 adults with a specific type of lung cancer will receive either the combo or durvalumab alone. The goal is to see if the combo delays cancer progression and improves survival.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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791 people
The number who actually took part.
- Started
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Feb 2022
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Participant must be ≥ 18 years at the time of screening. 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease 3. Provision of a tumour tissue sample obtained prior to CRT 4. Documented tumour PD-L1 status ≥ 1% by central lab 5. Documented EGFR and ALK wild-type status (local or central). 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy 8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. 9. WHO performance status of 0 or 1 at randomization 10. Adequate organ and marrow function EXCLUSION CRITERIA: 1. History of another primary malignancy, except for: * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence. * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease . * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease. 2. Mixed small cell and non-small cell lung cancer histology. 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia). 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy. 7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions) 9. Active EBV infection, or known or suspected chronic active EBV infection at screening 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chandler, Arizona, 85224, United States
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Phoenix, Arizona, 85054, United States
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Fountain Valley, California, 92708, United States
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Santa Rosa, California, 95403, United States
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Washington D.C., District of Columbia, 20016, United States
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Jacksonville, Florida, 32224, United States
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Orlando, Florida, 32804, United States
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Saint Augustine, Florida, 32086, United States
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Macon, Georgia, 31217, United States
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Elmhurst, Illinois, 60126, United States
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Louisville, Kentucky, 40202, United States
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Baltimore, Maryland, 21224, United States
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Silver Spring, Maryland, 20910, United States
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Ann Arbor, Michigan, 48106-0995, United States
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Detroit, Michigan, 48202, United States
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Minneapolis, Minnesota, 55407, United States
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Rochester, Minnesota, 55905, United States
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Reno, Nevada, 89511, United States
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East Brunswick, New Jersey, 08816, United States
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Columbus, Ohio, 43214, United States
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Maumee, Ohio, 43537, United States
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Oklahoma City, Oklahoma, 73102, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Charleston, South Carolina, 29401, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Fort Sam Houston, Texas, 78234, United States
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Fairfax, Virginia, 22031, United States
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Fort Belvoir, Virginia, 22060, United States
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Spokane Valley, Washington, 99216, United States
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Appleton, Wisconsin, 54911, United States
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Brussels, 1160, Belgium
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Edegem, 2650, Belgium
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Haine-Saint-Paul, 7100, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Sint-Niklaas, 9100, Belgium
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Barretos, 14784-400, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 91350200, Brazil
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Porto Velho, 76834-899, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01221-900, Brazil
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Taubaté, 12030-200, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Laval, Quebec, H7M 3L9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Las Condes, 7560908, Chile
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Port Montt, 5500243, Chile
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Santiago, 7500713, Chile
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Santiago, 7520426, Chile
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Santiago, 7630370, Chile
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Santiago, 8241479, Chile
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Temuco, 4810218, Chile
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Aix-en-Provence, 13616, France
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Angers, 49055, France
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Bobigny, 93000, France
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Lille, 59000, France
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Paris, 75014, France
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Pau, 6400, France
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Quimper, 29000, France
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Saint-Grégoire, 35760, France
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Saint-Quentin, 02321, France
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Vantoux, 57070, France
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Villeurbanne, 69100, France
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Berlin, 12351, Germany
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Berlin-Zehlendorf, 14165, Germany
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Braunschweig, 38114, Germany
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Chemnitz, 09116, Germany
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Cologne, 51109, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Giessen, 35392, Germany
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Halle, 06120, Germany
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Koblenz, 56073, Germany
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Krefeld, 47805, Germany
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Löwenstein, 74245, Germany
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Moers, 47441, Germany
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Regensburg, 93049, Germany
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Regensburg, 93053, Germany
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Tübingen, 72076, Germany
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Athens, 11526, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Athens, 18547, Greece
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Holargos, Athens, 155 62, Greece
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Thessaloniki, 55236, Greece
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Thessaloniki, 56 429, Greece
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Thessaloniki, 57001, Greece
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Hong Kong, 150001, Hong Kong
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Deszk, 6772, Hungary
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Győr, 9024, Hungary
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Salgótarján, 3100, Hungary
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Székesfehérvár, 8000, Hungary
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Törökbálint, 2045, Hungary
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Ahmedabad, 380054, India
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Bangalore, 560027, India
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Bangalore, 560064, India
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Delhi, 110085, India
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Howrah, 711103, India
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Hyderabad, 500032, India
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Jaipur, 302004, India
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Jaipur, 302022, India
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Kolkata, 700160, India
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Marg Jaipur, 302004, India
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Mohali, 160055, India
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Namakkal, 637001, India
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New Delhi, 110005, India
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New Delhi, 110029, India
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Varanasi, 221005, India
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Bergamo, 24127, Italy
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Roma, 00144, Italy
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Rozzano, 20089, Italy
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8603, Japan
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Bunkyō City, 113-8677, Japan
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Chiba, 260-8717, Japan
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Fukuoka, 812-8582, Japan
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Hidaka-shi, 350-1298, Japan
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Hirosaki-shi, 036-8563, Japan
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Itabashi-ku, 173-0003, Japan
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Kashihara-shi, 634-8522, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Osaka, 545-8586, Japan
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Osakasayama-shi, 589-8511, Japan
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Sapporo, 003-0804, Japan
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Sunto-gun, 411-8777, Japan
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Tokyo, 104-0045, Japan
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Yokohama, 221-0855, Japan
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Yokohama, 241-8515, Japan
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Johor Bahru, 81100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 46050, Malaysia
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Kuching, 93586, Malaysia
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Chihuahua City, 31207, Mexico
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Guadalajara, 44638, Mexico
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Mexico City, 03810, Mexico
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Oaxaca City, 68020, Mexico
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Bodø, 8092, Norway
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Gjøvik, 2819, Norway
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Oslo, 0379, Norway
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Trondheim, 0730, Norway
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City of Muntinlupa, 1780, Philippines
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Iloilo City, 5000, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1112, Philippines
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Bialystok, 15-027, Poland
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Gliwice, 44-102, Poland
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Katowice, 40-074, Poland
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Lodz, 93-513, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Bucharest, 022328, Romania
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Bucharest, 050098, Romania
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Craiova, 200542, Romania
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Floreşti, Romania
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Iași, 700483, Romania
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Oradea, 410001, Romania
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Sibiu, 550245, Romania
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Suceava, 720214, Romania
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eManzimtoti, 4126, South Africa
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Parktown, 2193, South Africa
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Pretoria, 0084, South Africa
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Daegu, 42415, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 21431, South Korea
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Incheon, 21565, South Korea
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Jinju, 52727, South Korea
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Seoul, 03722, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 07061, South Korea
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Suwon, 16247, South Korea
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Bilbao (Vizcaya), 48013, Spain
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Castellon, 12002, Spain
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Córdoba, 14004, Spain
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El Palmar, 30120, Spain
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Palma de Mallorca, 07010, Spain
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Sabadell (Barcelona), 08208, Spain
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Basel, 4031, Switzerland
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Bern, CH-3010, Switzerland
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Lausanne, 1011, Switzerland
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Hsinchu, 300, Taiwan
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New Taipei City, 220216, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10300, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Adapazarı, 54290, Turkey (Türkiye)
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Ankara, 06340, Turkey (Türkiye)
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Ankara, 6100, Turkey (Türkiye)
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Antalya, 07058, Turkey (Türkiye)
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Çankaya, 06680, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34662, Turkey (Türkiye)
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Izmir, 35360, Turkey (Türkiye)
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Konya, 42080, Turkey (Türkiye)
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Birmingham, B9 5SS, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Cheltenham, GL53 7AN, United Kingdom
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Edinburgh, EH4 2XR, United Kingdom
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High Heaton/Newcastle Upon Tyn, NE7 7DN, United Kingdom
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Leeds, LS 9 7TF, United Kingdom
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London, SE1 9RT, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Other studies related to the condition(s) this trial covers.
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