First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
1 other identifier
observational
1,156
10 countries
254
Brief Summary
This is a non-interventional/observational cohort of unresectable Stage III NSCLC patients treated with durvalumab. The study will be carried out as a retrospective review of established medical records of unresectable Stage III NSCLC patients treated with durvalumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Longer than P75 for all trials
254 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2018
CompletedFirst Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2024
CompletedJuly 16, 2025
July 1, 2025
5.6 years
December 21, 2018
July 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Real-world progression free survival (rwPFS)
PFS defined as time from the index date (D first dose date) to the date of investigator-determined disease progression or death (if no progression).
Patients are followed up from the index date (durvalumab (D) first dose date) to progressive disease (PD), death (if no PD), or loss to follow up if no PD/death. PFS reported at 1, 2, 3, and 5 years after D initiation.
Overall survival (OS)
OS defined as time from the index date (D first dose date) to the date of death.
Patients are followed up from the index date (D first dose date) to death or loss to follow up in the absence of death. OS reported at 2, 3, and 5 years after D initiation.
Secondary Outcomes (4)
Adverse events of special interest
Adverse event data are collected from the time of starting durvalumab (D) throughout the D treatment period up to 90 days after last D infusion or at time of next subsequent therapy initiation (whichever occurred earlier).
Time to death or distant metastasis
Patients are followed up from the index date (D first dose date) to distant metastasis (DM), death (if no DM), or loss to follow up if no DM/death. Time to death or DM reported at 1, 2, 3, and 5 years after the D initiation.
Time to death or local recurrence
Patients are followed up from the index date (D first dose date) to local recurrence (LR), death (if no LR), or loss to follow up if no LR/death. Time to death or LR reported at 1, 2, 3, and 5 years after the D initiation.
Time to first subsequent treatment or death
Patients are followed up from the index date (D first dose date) to first subsequent treatment (ST) after D, death (if no ST), or loss to follow up if no ST/death. Time to first ST/death reported at 1, 2, 3, and 5 years after the D initiation.
Eligibility Criteria
Patients were selected from the following participating countries: Australia, Belgium, Israel, Netherlands, Norway, France, Germany, Italy, Switzerland, Spain\* and the United Kingdom. Data will be collected from those patients who have received at least one dose of durvalumab between Sep 2017 through 21 Dec 2018. Patients may participate in other clinical trials during this follow-up period. Patients must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. There is no fixed max duration for durvalumab treatment and it continues until the physician determines that it is in the patient's best interest to stop therapy. Later EAP protocol was amended to allow durvalumab treatment duration of no more than 12 months. \*Spain only contributed to DE1 and DE2.
You may qualify if:
- Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
- 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).
You may not qualify if:
- Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (254)
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Ballarat, 3350, Australia
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Bankstown, 2200, Australia
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Bedford Park, 5042, Australia
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Bendigo, 3550, Australia
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Bentleigh East, 3165, Australia
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Bowral, 2576, Australia
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Box Hill, 3128, Australia
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Campbelltown, 2560, Australia
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Camperdown, 2050, Australia
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Canberra, 2605, Australia
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Clayton, 3168, Australia
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Coffs Harbour, 2450, Australia
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Douglas, 4814, Australia
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Elizabeth Vale, 5112, Australia
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Frankston, 3199, Australia
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Hamlyn Terrace, 2259, Australia
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Hervey Bay, 4655, Australia
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Hobart, 7000, Australia
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Joondalup, 6027, Australia
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Kingswood, 2747, Australia
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Liverpool, 2170, Australia
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Malvern, 3144, Australia
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Melbourne, 3000, Australia
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Melbourne, 3004, Australia
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Murdoch, 6150, Australia
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Orange, 2800, Australia
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Rockhampton, 4700, Australia
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St Leonards, 2065, Australia
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Subiaco, 6008, Australia
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Traralgon, 3844, Australia
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Tugun, 4224, Australia
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Warrnambool, 3280, Australia
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Wendouree, 3355, Australia
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Westmead, 2145, Australia
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Wollongong, 2500, Australia
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Aalst, 9300, Belgium
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Bouge, 5004, Belgium
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Braine-l'Alleud, 1420, Belgium
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Brasschaat, 2930, Belgium
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Brussels, 1000, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Dendermonde, 9200, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Herstal, 4040, Belgium
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Heusden-Zolder, 3550, Belgium
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Ieper, 8900, Belgium
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Kuringen, 2820, Belgium
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Liège, 4000, Belgium
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Loverval, 6280, Belgium
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Mons, 7000, Belgium
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Ottignies, 1340, Belgium
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Roeselare, 8800, Belgium
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Ronse, 9600, Belgium
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Sint-Niklaas, 9100, Belgium
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Sint-Truiden, 3800, Belgium
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Yvoir, 5530, Belgium
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Abbeville, 80100, France
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Aix-en-Provence, 13100, France
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Albi, 81013, France
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Antony, 92160, France
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Avignon, 84918, France
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Bayonne, 64100, France
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Béthune, 62408, France
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Béziers, 34500, France
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Bobigny, 93009, France
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Bordeaux, 33030, France
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Bordeaux, 33300, France
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Boulogne-Billancourt, 92104, France
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Brest, 29609, France
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Carcassonne, 11010, France
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Chauny, 02303, France
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Clermont-Ferrand, 63000, France
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Colmar, 68024, France
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Contamine-sur-Arve, 74130, France
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Créteil, 94010, France
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Dijon, 21033, France
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Dijon, 21079, France
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Gap, 5007, France
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Grenoble, 38700, France
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La Roche-sur-Yon, 85925, France
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La Rochelle, 17019, France
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Le Mans, 72037, France
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Levallois-Perret, 92300, France
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Libourne, 33505, France
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Lille, 59037, France
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Limoges, 87000, France
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Lorient, 56322, France
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Lyon, 69373, France
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Marseille, 13003, France
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Marseille, 13015, France
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Mâcon, 71018, France
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Metz-Tessy, 74370, France
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Montpellier, 34070, France
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Montpellier, 34298, France
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Morlaix, 29572, France
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Muret, France
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Nancy, 54100, France
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Nîmes, 30029, France
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Paris, 75005, France
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Paris, 75014, France
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Paris, 75018, France
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Paris, 75020, France
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Paris, 75475, France
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Pau, 6400, France
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Perpignan, 66046, France
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Périgueux, 24000, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Rennes, 35033, France
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Rouen, 76031, France
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Saint-Aubin-lès-Elbeuf, 76410, France
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Saint-Nazaire, 44606, France
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Saint-Priest-en-Jarez, 42270, France
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Saint-Quentin, 02321, France
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Tarbes, 65000, France
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Toulon, 83041, France
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Toulouse, 31059, France
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Tours, 37044, France
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Valence, 26000, France
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Vantoux, 57070, France
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Villefranche-sur-Saône, 69400, France
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Berlin, 12351, Germany
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Bochum, 44791, Germany
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Bremen, 28205, Germany
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Dresden, 1307, Germany
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Erlangen, 91054, Germany
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Essen, 45136, Germany
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Esslingen am Neckar, 73730, Germany
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Fürth, 90766, Germany
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Georgsmarienhütte, 49124, Germany
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Gütersloh, 33334, Germany
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Halle, 06120, Germany
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Hamburg, 20246, Germany
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Hamburg, 20249, Germany
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Hamburg, 21075, Germany
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Immenhausen, 34376, Germany
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Kaiserslautern, 67655, Germany
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Karlsruhe, 76137, Germany
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Kempten, 87439, Germany
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München, 80336, Germany
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Münnerstadt, 97702, Germany
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Oldenburg, 26121, Germany
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Paderborn, 33098, Germany
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Recklinghausen, 45657, Germany
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Regensburg, 93049, Germany
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Regensburg, 93053, Germany
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Rostock, 18057, Germany
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Würselen, 52146, Germany
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Ashkelon, 78278, Israel
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Beersheba, 8410101, Israel
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Haifa, 34362, Israel
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Haifa, 91096, Israel
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Holon, 58100, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Nahariya, 22100, Israel
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Nazareth, 16100, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 62748, Israel
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Tel Aviv, 6423906, Israel
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Alessandria, 15100, Italy
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Ancona, 60122, Italy
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Arezzo, 52100, Italy
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Aviano, 33081, Italy
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Bari, 70124, Italy
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Bolzano, 39100, Italy
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Brescia, 25100, Italy
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Brescia, 25123, Italy
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Catanzaro, 88100, Italy
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Feltre, 32032, Italy
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Florence, 50141, Italy
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Genova, 16121, Italy
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Genova, 16132, Italy
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Imola, 40026, Italy
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La Spezia, 19124, Italy
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Lecce, 73100, Italy
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Lido di Camaiore, 55041, Italy
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L’Aquila, 67100, Italy
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Meldola, 47014, Italy
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Messina, 98158, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Mirano, 30035, Italy
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Modena, 41124, Italy
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Monza, 20900, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Parma, 43126, Italy
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Pavia, 27100, Italy
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Perugia, 06132, Italy
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Pisa, 56124, Italy
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Pistoia, 51100, Italy
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Ravenna, 48121, Italy
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Reggio Emilia, 42100, Italy
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Rimini, 47923, Italy
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Rionero in Vulture, 85028, Italy
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Roma, 00161, Italy
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Roma, 00189, Italy
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Rozzano, 20089, Italy
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Sora, 03039, Italy
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Terni, 05100, Italy
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Treviglio, 24047, Italy
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Trieste, 34100, Italy
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Udine, 33100, Italy
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Varese, 21100, Italy
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Verona, 37124, Italy
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's-Hertogenbosch, 5223 GZ, Netherlands
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Alkmaar, 1815JD, Netherlands
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Amersfoort, 3813 TZ, Netherlands
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1091 AC, Netherlands
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Arnhem, 6815 AD, Netherlands
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Breda, 4818 CK, Netherlands
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Ede, 6716 RP, Netherlands
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Eindhoven, 5631 BM, Netherlands
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Groningen, 9713 GZ, Netherlands
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Groningen, 9728 NT, Netherlands
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Heerlen, 6419 PC, Netherlands
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Hilversum, 1313 XZ, Netherlands
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Leiden, 2300 RC, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Nieuwegein, 3430EM, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3015 GD, Netherlands
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The Hague, 2545 AA, Netherlands
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Utrecht, 3584 CX, Netherlands
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Zutphen, 7207 AE, Netherlands
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Arendal, 4809, Norway
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Drammen, 3004, Norway
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Oslo, 450, Norway
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Tromsø, 9038, Norway
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Altdorf, CH-6460, Switzerland
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Bülach, 8180, Switzerland
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Chur, CH-7000, Switzerland
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Fribourg, 1700, Switzerland
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Geneva, 1205, Switzerland
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Lausanne, 1011, Switzerland
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Neuchâtel, 2000, Switzerland
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Birmingham, B9 5SS, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Colchester, CO4 5JL, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW17 0QT, United Kingdom
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London, SW3 6JJ, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Poole, BH15 2JB, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (3)
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.
PMID: 37476372DERIVEDZhao 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.
PMID: 36990576DERIVEDGirard 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.
PMID: 36307040DERIVED
Related Links
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2018
First Posted
January 10, 2019
Study Start
December 19, 2018
Primary Completion
July 16, 2024
Study Completion
July 16, 2024
Last Updated
July 16, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.