A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
NCT ID: NCT05211895
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
860 participants
INTERVENTIONAL
2022-02-18
2030-10-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A: Durvalumab + Domvanalimab
Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
Durvalumab
Durvalumab IV (Intravenous infusion)
Domvanalimab
Domvanalimab IV (Intravenous infusion)
Arm B: Durvalumab + Placebo
Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months
Durvalumab
Durvalumab IV (Intravenous infusion)
Placebo
Placebo IV (Intravenous infusion)
Interventions
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Durvalumab
Durvalumab IV (Intravenous infusion)
Domvanalimab
Domvanalimab IV (Intravenous infusion)
Placebo
Placebo IV (Intravenous infusion)
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Hidehito Horinouchi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center Hospital
Alexander Spira, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Cancer Specialists Research Institute
Jinming Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Locations
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Fountain Valley, California, United States
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Santa Rosa, California, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Saint Augustine, Florida, United States
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Macon, Georgia, United States
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Elmhurst, Illinois, United States
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Maywood, Illinois, United States
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Naperville, Illinois, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Silver Spring, Maryland, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Reno, Nevada, United States
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East Brunswick, New Jersey, United States
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Florham Park, New Jersey, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
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Asheville, North Carolina, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Maumee, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Fort Sam Houston, Texas, United States
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Kingwood, Texas, United States
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Arlington, Virginia, United States
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Fort Belvoir, Virginia, United States
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Spokane Valley, Washington, United States
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Appleton, Wisconsin, United States
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Brussels, , Belgium
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Edegem, , Belgium
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Haine-Saint-Paul, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Sint-Niklaas, , Belgium
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Barretos, , Brazil
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Londrina, , Brazil
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Porto Alegre, , Brazil
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Porto Velho, , Brazil
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Rio de Janeiro, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Taubaté, , Brazil
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Las Condes, , Chile
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Port Montt, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Aix-en-Provence, , France
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Angers, , France
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Bobigny, , France
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Clermont-Ferrand, , France
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Lille, , France
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Paris, , France
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Pau, , France
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Quimper, , France
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Saint-Grégoire, , France
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Saint-Quentin, , France
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Vantoux, , France
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Villeurbanne, , France
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Berlin, , Germany
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Berlin-Zehlendorf, , Germany
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Braunschweig, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Georgsmarienhütte, , Germany
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Giessen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Homburg, , Germany
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Koblenz, , Germany
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Krefeld, , Germany
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Löwenstein, , Germany
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Moers, , Germany
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München, , Germany
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Regensburg, , Germany
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Regensburg, , Germany
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Tübingen, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Holargos, Athens, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Győr, , Hungary
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Salgótarján, , Hungary
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Székesfehérvár, , Hungary
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Törökbálint, , Hungary
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Ahmedabad, , India
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Bangalore, , India
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Bangalore, , India
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Delhi, , India
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Gurgaon, , India
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Howrah, , India
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Hyderabad, , India
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Jaipur, , India
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Jaipur, , India
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Kolkata, , India
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Marg Jaipur, , India
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Mohali, , India
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Namakkal, , India
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New Delhi, , India
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New Delhi, , India
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Varanasi, , India
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Bergamo, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Udine, , Italy
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Bunkyō City, , Japan
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Bunkyō City, , Japan
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Bunkyō City, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Hidaka-shi, , Japan
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Hirosaki-shi, , Japan
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Itabashi-ku, , Japan
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Kashihara-shi, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sapporo, , Japan
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Sunto-gun, , Japan
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Tokyo, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Johor Bahru, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Kuching, , Malaysia
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Oaxaca City, , Mexico
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San Pedro Garza García, , Mexico
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Sonora, , Mexico
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Veracruz, , Mexico
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Bodø, , Norway
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Gjøvik, , Norway
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Oslo, , Norway
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Trondheim, , Norway
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Bacolod, , Philippines
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City of Muntinlupa, , Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Gliwice, , Poland
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Gliwice, , Poland
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Katowice, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zielona Góra, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Craiova, , Romania
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Floreşti, , Romania
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Iași, , Romania
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Oradea, , Romania
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Sibiu, , Romania
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Suceava, , Romania
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Timișoara, , Romania
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Cape Town, , South Africa
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eManzimtoti, , South Africa
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eManzimtoti, , South Africa
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Johannesburg, , South Africa
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Parktown, , South Africa
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Pretoria, , South Africa
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Daegu, , South Korea
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Goyang-si, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Bilbao (Vizcaya), , Spain
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Castellon, , Spain
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Córdoba, , Spain
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El Palmar, , Spain
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Palma de Mallorca, , Spain
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Sabadell (Barcelona), , Spain
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Basel, , Switzerland
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Bern, , Switzerland
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Lausanne, , Switzerland
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Hsinchu, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Adapazarı, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Çankaya, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Konya, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Brighton, , United Kingdom
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Cambridge, , United Kingdom
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Cardiff, , United Kingdom
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Cheltenham, , United Kingdom
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Edinburgh, , United Kingdom
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High Heaton/Newcastle Upon Tyn, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Truro, , United Kingdom
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
AstraZeneca Lung Cancer Study Locator Service
Role: CONTACT
Phone: 1-884-432-3892
Email: [email protected]
Related Links
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1-844-432-3892 Lung Cancer Study Locator details to CT.gov for the US sites only
Other Identifiers
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2021-004327-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9075C00001
Identifier Type: -
Identifier Source: org_study_id