First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
NCT ID: NCT03798535
Last Updated: 2025-07-16
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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COMPLETED
1156 participants
OBSERVATIONAL
2018-12-19
2024-07-16
Brief Summary
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The study will be carried out as a retrospective review of established medical records of unresectable Stage III NSCLC patients treated with durvalumab.
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Detailed Description
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Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment.
* First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of unresectable Stage III NSCLC to durvalumab start date (index date).
* The second chart extraction will be triggered at time of estimated maturity of PFS data.
* The third chart extraction will be triggered at time of estimated maturity of OS data.
* The fourth (final) chart extractions will occur 5-years after EAP enrolment to provide final PFS and OS data, together with updated results for all secondary and descriptive endpoints.
* The dates for the second through fourth chart abstractions may be adjusted, pending data availability. The estimated PFS and OS maturity will be calculated from the actual patient index dates (date of first dose of durvalumab) together with the distribution of PFS and OS observed in the PACIFIC trial.
* Spain only contributed to DE1 and DE2.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years at time of study entry or adult according to each country regulations for age of majority
* Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 7 or 8)
* Patients must have been enrolled in one of the durvalumab EAPs Patients must have been treated with at least one dose of durvalumab within the EAP prior to the study entry and between start of EAP in the country, from September 2017 or later up to end of EAP enrolment or MA + three months (estimated as maximum to 30 December 2018) (whichever occurs earlier).
Exclusion Criteria
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Ballarat, , Australia
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Bankstown, , Australia
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Bedford Park, , Australia
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Bendigo, , Australia
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Bentleigh East, , Australia
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Bowral, , Australia
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Box Hill, , Australia
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Campbelltown, , Australia
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Camperdown, , Australia
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Canberra, , Australia
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Clayton, , Australia
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Coffs Harbour, , Australia
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Douglas, , Australia
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Elizabeth Vale, , Australia
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Frankston, , Australia
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Hamlyn Terrace, , Australia
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Hervey Bay, , Australia
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Hobart, , Australia
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Joondalup, , Australia
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Kingswood, , Australia
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Liverpool, , Australia
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Malvern, , Australia
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Melbourne, , Australia
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Melbourne, , Australia
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Murdoch, , Australia
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Orange, , Australia
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Rockhampton, , Australia
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St Leonards, , Australia
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Subiaco, , Australia
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Traralgon, , Australia
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Tugun, , Australia
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Warrnambool, , Australia
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Wendouree, , Australia
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Westmead, , Australia
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Wollongong, , Australia
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Aalst, , Belgium
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Bouge, , Belgium
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Braine-l'Alleud, , Belgium
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Brasschaat, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Dendermonde, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Herstal, , Belgium
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Heusden-Zolder, , Belgium
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Ieper, , Belgium
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Kuringen, , Belgium
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Liège, , Belgium
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Loverval, , Belgium
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Mons, , Belgium
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Ottignies, , Belgium
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Roeselare, , Belgium
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Ronse, , Belgium
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Sint-Niklaas, , Belgium
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Sint-Truiden, , Belgium
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Yvoir, , Belgium
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Abbeville, , France
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Aix-en-Provence, , France
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Albi, , France
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Antony, , France
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Avignon, , France
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Bayonne, , France
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Béthune, , France
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Béziers, , France
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Bobigny, , France
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Bordeaux, , France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Brest, , France
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Carcassonne, , France
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Chauny, , France
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Clermont-Ferrand, , France
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Colmar, , France
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Contamine-sur-Arve, , France
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Créteil, , France
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Dijon, , France
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Dijon, , France
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Gap, , France
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Grenoble, , France
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La Roche-sur-Yon, , France
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La Rochelle, , France
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Le Mans, , France
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Levallois-Perret, , France
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Libourne, , France
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Lille, , France
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Limoges, , France
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Lorient, , France
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Lyon, , France
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Marseille, , France
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Marseille, , France
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Mâcon, , France
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Metz-Tessy, , France
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Montpellier, , France
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Montpellier, , France
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Morlaix, , France
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Muret, , France
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Nancy, , France
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Nîmes, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Pau, , France
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Perpignan, , France
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Périgueux, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Rennes, , France
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Rouen, , France
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Saint-Aubin-lès-Elbeuf, , France
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Saint-Nazaire, , France
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Saint-Priest-en-Jarez, , France
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Saint-Quentin, , France
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Tarbes, , France
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Toulon, , France
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Toulouse, , France
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Tours, , France
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Valence, , France
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Vantoux, , France
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Villefranche-sur-Saône, , France
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Berlin, , Germany
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Bochum, , Germany
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Bremen, , Germany
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Dresden, , 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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Fürth, , Germany
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Georgsmarienhütte, , Germany
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Gütersloh, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Immenhausen, , Germany
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Kaiserslautern, , Germany
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Karlsruhe, , Germany
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Kempten, , Germany
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München, , Germany
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Münnerstadt, , Germany
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Oldenburg, , Germany
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Paderborn, , Germany
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Recklinghausen, , Germany
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Regensburg, , Germany
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Regensburg, , Germany
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Rostock, , Germany
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Würselen, , Germany
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Ashkelon, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Nazareth, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Tel Aviv, , Israel
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Alessandria, , Italy
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Ancona, , Italy
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Arezzo, , Italy
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Aviano, , Italy
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Bari, , Italy
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Bolzano, , Italy
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Brescia, , Italy
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Brescia, , Italy
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Catanzaro, , Italy
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Feltre, , Italy
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Florence, , Italy
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Genova, , Italy
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Genova, , Italy
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Imola, , Italy
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La Spezia, , Italy
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Lecce, , Italy
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Lido di Camaiore, , Italy
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L’Aquila, , Italy
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Meldola, , Italy
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Messina, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Mirano, , Italy
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Modena, , Italy
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Monza, , Italy
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Napoli, , Italy
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Padua, , Italy
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Parma, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Pistoia, , Italy
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Ravenna, , Italy
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Reggio Emilia, , Italy
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Rimini, , Italy
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Rionero in Vulture, , Italy
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Roma, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Sora, , Italy
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Terni, , Italy
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Treviglio, , Italy
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Trieste, , Italy
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Udine, , Italy
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Varese, , Italy
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Verona, , Italy
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's-Hertogenbosch, , Netherlands
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Alkmaar, , Netherlands
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Amersfoort, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Breda, , Netherlands
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Ede, , Netherlands
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Groningen, , Netherlands
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Heerlen, , Netherlands
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Hilversum, , Netherlands
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Leiden, , Netherlands
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Maastricht, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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The Hague, , Netherlands
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Utrecht, , Netherlands
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Zutphen, , Netherlands
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Arendal, , Norway
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Drammen, , Norway
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Oslo, , Norway
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Tromsø, , Norway
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Altdorf, , Switzerland
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Bülach, , Switzerland
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Chur, , Switzerland
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Fribourg, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Neuchâtel, , Switzerland
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Birmingham, , United Kingdom
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Cardiff, , United Kingdom
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Colchester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
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Poole, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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Langberg CW, Horndalsveen H, Helland A, Haakensen VD. Factors associated with failure to start consolidation durvalumab after definitive chemoradiation for locally advanced NSCLC. Front Oncol. 2023 Jul 5;13:1217424. doi: 10.3389/fonc.2023.1217424. eCollection 2023.
Zhao B, Li H, Ma W. Durvalumab After Chemoradiotherapy for Patients With Unresectable Stage III NSCLC: The PACIFIC-R Study. J Thorac Oncol. 2023 Apr;18(4):e38-e39. doi: 10.1016/j.jtho.2022.11.002. No abstract available.
Girard N, Bar J, Garrido P, Garassino MC, McDonald F, Mornex F, Filippi AR, Smit HJM, Peters S, Field JK, Christoph DC, Sibille A, Fietkau R, Haakensen VD, Chouaid C, Markman B, Hiltermann TJN, Taus A, Sawyer W, Allen A, Chander P, Licour M, Solomon B. Treatment Characteristics and Real-World Progression-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study. J Thorac Oncol. 2023 Feb;18(2):181-193. doi: 10.1016/j.jtho.2022.10.003. Epub 2022 Oct 25.
Related Links
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Other Identifiers
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D4194R00005
Identifier Type: -
Identifier Source: org_study_id
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