A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
NCT ID: NCT05221840
Last Updated: 2025-07-23
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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ACTIVE_NOT_RECRUITING
PHASE3
1027 participants
INTERVENTIONAL
2022-02-07
2030-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A: Durvalumab and Oleclumab
Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Durvalumab
Durvalumab IV (intravenous infusion)
Oleclumab
Oleclumab IV (intravenous infusion)
Arm B: Durvalumab and Monalizumab
Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
Durvalumab
Durvalumab IV (intravenous infusion)
Monalizumab
Monalizumab IV (intravenous infusion)
Placebo
Placebo IV (intravenous infusion)
Arm C: Durvalumab and Placebo
Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Durvalumab
Durvalumab IV (intravenous infusion)
Placebo
Placebo IV (intravenous infusion)
Interventions
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Durvalumab
Durvalumab IV (intravenous infusion)
Oleclumab
Oleclumab IV (intravenous infusion)
Monalizumab
Monalizumab IV (intravenous infusion)
Placebo
Placebo IV (intravenous infusion)
Eligibility Criteria
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Inclusion Criteria
* Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
* Provision of a tumour tissue sample obtained prior to CRT
* Documented tumour PD-L1 status by central lab
* Documented EGFR and ALK wild-type status (local or central).
* Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
* Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
* 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.
* WHO performance status of 0 or 1 at randomization
* Adequate organ and marrow function
Exclusion Criteria
* Mixed small cell and non-small cell lung cancer histology.
* Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
* Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
* Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
* Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
* 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 - diagnosed in the past 6 months prior to randomization.
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* 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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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Fabrice Barlesi, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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San Diego, California, United States
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New Haven, Connecticut, United States
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Stuart, Florida, United States
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Urbana, Illinois, United States
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New Albany, Indiana, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Grand Rapids, Michigan, United States
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Duluth, Minnesota, United States
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Billings, Montana, United States
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Ridgewood, New Jersey, United States
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Ithaca, New York, United States
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Greensboro, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Maumee, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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York, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Houston, Texas, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Fredericksburg, Virginia, United States
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Richmond, Virginia, United States
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Richland, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Box Hill, , Australia
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East Melbourne, , Australia
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Elizabeth Vale, , Australia
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Gosford, , Australia
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Heidelberg, , Australia
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Kogarah, , Australia
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South Brisbane, , Australia
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St Albans, , Australia
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Westmead, , Australia
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Barretos, , Brazil
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Belo Horizonte, , Brazil
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Jaú, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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São Paulo, , Brazil
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Uberlândia, , Brazil
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Vitória, , Brazil
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Edmonton, Alberta, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Rimouski, Quebec, Canada
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Anyang, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Hefei, , China
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Kunming, , China
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Linhai, , China
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Nanchang, , China
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Nanning, , China
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Nantong, , China
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Neijiang, , China
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Ningbo, , China
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Shaoguan, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Zhanjiang, , China
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Zhengzhou, , China
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Zhengzhou, , China
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Zhongshan, , China
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Barranquilla, , Colombia
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Bogota D.C., , Colombia
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Medellín, , Colombia
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Valledupar, , Colombia
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Avignon, , France
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Besançon, , France
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Bordeaux, , France
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Clermont-Ferrand, , France
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Créteil, , France
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Lorient, , France
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Marseille, , France
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Montpellier, , France
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Rennes, , France
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Rouen, , France
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Toulouse, , France
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Villejuif, , France
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Erfurt, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Georgsmarienhütte, , Germany
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Gütersloh, , Germany
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Hanover, , Germany
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Oldenburg, , Germany
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Würzburg, , Germany
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Brescia, , Italy
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Florence, , Italy
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Lucca, , Italy
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Meldola, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Pavia, , Italy
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Roma, , Italy
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Himeji-shi, , Japan
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Hiroshima, , Japan
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Kashiwa, , Japan
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Kurume-shi, , Japan
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Natori-shi, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Sendai, , Japan
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Tokushima, , Japan
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Toon-shi, , Japan
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Wakayama, , Japan
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Koszalin, , Poland
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Poznan, , Poland
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Siedlce, , Poland
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Tomaszów Mazowiecki, , Poland
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Warsaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Loures, , Portugal
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Porto, , Portugal
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Changwon-si, , South Korea
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Cheongju-si, , South Korea
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Seongnam-si, , 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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Suwon, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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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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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Khon Kaen, , Thailand
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Lampang, , Thailand
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Muang, , Thailand
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Muang, , Thailand
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Mueang, , Thailand
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Naimuang, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Goztepe Istanbul, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Belfast, , United Kingdom
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Bristol, , United Kingdom
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Dundee, , United Kingdom
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Edinburgh, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Middlesbrough, , United Kingdom
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Poole, , United Kingdom
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Torquay, , United Kingdom
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Truro, , United Kingdom
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Wolverhampton, , United Kingdom
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Haiphong, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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Barlesi F, Cho BC, Goldberg SB, Yoh K, Zimmer Gelatti AC, Mann H, Gopinathan A, Bielecka ZF, Newton M, Aggarwal C. PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer. Future Oncol. 2024;20(29):2137-2147. doi: 10.1080/14796694.2024.2354160. Epub 2024 Jul 18.
Related Links
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Lung Cancer Study Locator details
Other Identifiers
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2023-503999-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-004346-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9078C00001
Identifier Type: -
Identifier Source: org_study_id
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