NSCLCNCT03798535
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
An observational study of NSCLC, run by AstraZeneca at 254 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- NSCLC
- How many people
- 1,156 participants
- Where
- 254 sitesin 10 countries
- Study dates
- 19 Dec 2018to 16 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
- Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met.
Who cannot join
- -Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Trial locations and contacts
254 sites in 10 countries.
254 sites in 10 countries
France65 sites
Research Site
Abbeville, 80100
Research Site
Aix-en-Provence, 13100
Research Site
Albi, 81013
Research Site
Antony, 92160
Research Site
Avignon, 84918
Research Site
Bayonne, 64100
Research Site
Béthune, 62408
Research Site
Béziers, 34500
Research Site
Bobigny, 93009
Research Site
Bordeaux, 33030
Research Site
Bordeaux, 33300
Research Site
Boulogne-Billancourt, 92104
Research Site
Brest, 29609
Research Site
Carcassonne, 11010
Research Site
Chauny, 02303
Research Site
Clermont-Ferrand, 63000
Research Site
Colmar, 68024
Research Site
Contamine-sur-Arve, 74130
Research Site
Créteil, 94010
Research Site
Dijon, 21033
Research Site
Dijon, 21079
Research Site
Gap, 5007
Research Site
Grenoble, 38700
Research Site
La Roche-sur-Yon, 85925
Research Site
La Rochelle, 17019
Research Site
Le Mans, 72037
Research Site
Levallois-Perret, 92300
Research Site
Libourne, 33505
Research Site
Lille, 59037
Research Site
Limoges, 87000
Research Site
Lorient, 56322
Research Site
Lyon, 69373
Research Site
Mâcon, 71018
Research Site
Marseille, 13003
Research Site
Marseille, 13015
Research Site
Metz-Tessy, 74370
Research Site
Montpellier, 34070
Research Site
Montpellier, 34298
Research Site
Morlaix, 29572
Research Site
Muret
Research Site
Nancy, 54100
Research Site
Nîmes, 30029
Research Site
Paris, 75005
Research Site
Paris, 75014
Research Site
Paris, 75018
Research Site
Paris, 75020
Research Site
Paris, 75475
Research Site
Pau, 6400
Research Site
Périgueux, 24000
Research Site
Perpignan, 66046
Research Site
Pierre-Bénite, 69495
Research Site
Poitiers, 86021
Research Site
Rennes, 35033
Research Site
Rouen, 76031
Research Site
Saint-Aubin-lès-Elbeuf, 76410
Research Site
Saint-Nazaire, 44606
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Saint-Quentin, 02321
Research Site
Tarbes, 65000
Research Site
Toulon, 83041
Research Site
Toulouse, 31059
Research Site
Tours, 37044
Research Site
Valence, 26000
Research Site
Vantoux, 57070
Research Site
Villefranche-sur-Saône, 69400
Italy47 sites
Research Site
Alessandria, 15100
Research Site
Ancona, 60122
Research Site
Arezzo, 52100
Research Site
Aviano, 33081
Research Site
Bari, 70124
Research Site
Bolzano, 39100
Research Site
Brescia, 25100
Research Site
Brescia, 25123
Research Site
Catanzaro, 88100
Research Site
Feltre, 32032
Research Site
Florence, 50141
Research Site
Genova, 16121
Research Site
Genova, 16132
Research Site
Imola, 40026
Research Site
L’Aquila, 67100
Research Site
La Spezia, 19124
Research Site
Lecce, 73100
Research Site
Lido di Camaiore, 55041
Research Site
Meldola, 47014
Research Site
Messina, 98158
Research Site
Milan, 20132
Research Site
Milan, 20133
Research Site
Milan, 20141
Research Site
Mirano, 30035
Research Site
Modena, 41124
Research Site
Monza, 20900
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Parma, 43126
Research Site
Pavia, 27100
Research Site
Perugia, 06132
Research Site
Pisa, 56124
Research Site
Pistoia, 51100
Research Site
Ravenna, 48121
Research Site
Reggio Emilia, 42100
Research Site
Rimini, 47923
Research Site
Rionero in Vulture, 85028
Research Site
Roma, 00161
Research Site
Roma, 00189
Research Site
Rozzano, 20089
Research Site
Sora, 03039
Research Site
Terni, 05100
Research Site
Treviglio, 24047
Research Site
Trieste, 34100
Research Site
Udine, 33100
Research Site
Varese, 21100
Research Site
Verona, 37124
Australia35 sites
Research Site
Ballarat, 3350
Research Site
Bankstown, 2200
Research Site
Bedford Park, 5042
Research Site
Bendigo, 3550
Research Site
Bentleigh East, 3165
Research Site
Bowral, 2576
Research Site
Box Hill, 3128
Research Site
Campbelltown, 2560
Research Site
Camperdown, 2050
Research Site
Canberra, 2605
Research Site
Clayton, 3168
Research Site
Coffs Harbour, 2450
Research Site
Douglas, 4814
Research Site
Elizabeth Vale, 5112
Research Site
Frankston, 3199
Research Site
Hamlyn Terrace, 2259
Research Site
Hervey Bay, 4655
Research Site
Hobart, 7000
Research Site
Joondalup, 6027
Research Site
Kingswood, 2747
Research Site
Liverpool, 2170
Research Site
Malvern, 3144
Research Site
Melbourne, 3000
Research Site
Melbourne, 3004
Research Site
Murdoch, 6150
Research Site
Orange, 2800
Research Site
Rockhampton, 4700
Research Site
St Leonards, 2065
Research Site
Subiaco, 6008
Research Site
Traralgon, 3844
Research Site
Tugun, 4224
Research Site
Warrnambool, 3280
Research Site
Wendouree, 3355
Research Site
Westmead, 2145
Research Site
Wollongong, 2500
Germany27 sites
Research Site
Berlin, 12351
Research Site
Bochum, 44791
Research Site
Bremen, 28205
Research Site
Dresden, 1307
Research Site
Erlangen, 91054
Research Site
Essen, 45136
Research Site
Esslingen am Neckar, 73730
Research Site
Fürth, 90766
Research Site
Georgsmarienhütte, 49124
Research Site
Gütersloh, 33334
Research Site
Halle, 06120
Research Site
Hamburg, 20246
Research Site
Hamburg, 20249
Research Site
Hamburg, 21075
Research Site
Immenhausen, 34376
Research Site
Kaiserslautern, 67655
Research Site
Karlsruhe, 76137
Research Site
Kempten, 87439
Research Site
München, 80336
Research Site
Münnerstadt, 97702
Research Site
Oldenburg, 26121
Research Site
Paderborn, 33098
Research Site
Recklinghausen, 45657
Research Site
Regensburg, 93049
Research Site
Regensburg, 93053
Research Site
Rostock, 18057
Research Site
Würselen, 52146
Belgium23 sites
Research Site
Aalst, 9300
Research Site
Bouge, 5004
Research Site
Braine-l'Alleud, 1420
Research Site
Brasschaat, 2930
Research Site
Brussels, 1000
Research Site
Brussels, 1090
Research Site
Brussels, 1200
Research Site
Dendermonde, 9200
Research Site
Ghent, 9000
Research Site
Hasselt, 3500
Research Site
Herstal, 4040
Research Site
Heusden-Zolder, 3550
Research Site
Ieper, 8900
Research Site
Kuringen, 2820
Research Site
Liège, 4000
Research Site
Loverval, 6280
Research Site
Mons, 7000
Research Site
Ottignies, 1340
Research Site
Roeselare, 8800
Research Site
Ronse, 9600
Research Site
Sint-Niklaas, 9100
Research Site
Sint-Truiden, 3800
Research Site
Yvoir, 5530
Netherlands21 sites
Research Site
's-Hertogenbosch, 5223 GZ
Research Site
Alkmaar, 1815JD
Research Site
Amersfoort, 3813 TZ
Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1091 AC
Research Site
Arnhem, 6815 AD
Research Site
Breda, 4818 CK
Research Site
Ede, 6716 RP
Research Site
Eindhoven, 5631 BM
Research Site
Groningen, 9713 GZ
Research Site
Groningen, 9728 NT
Research Site
Heerlen, 6419 PC
Research Site
Hilversum, 1313 XZ
Research Site
Leiden, 2300 RC
Research Site
Maastricht, 6202 AZ
Research Site
Nieuwegein, 3430EM
Research Site
Nijmegen, 6525 GA
Research Site
Rotterdam, 3015 GD
Research Site
The Hague, 2545 AA
Research Site
Utrecht, 3584 CX
Research Site
Zutphen, 7207 AE
Israel13 sites
Research Site
Ashkelon, 78278
Research Site
Beersheba, 8410101
Research Site
Haifa, 34362
Research Site
Haifa, 91096
Research Site
Holon, 58100
Research Site
Jerusalem, 9112001
Research Site
Kfar Saba, 4428164
Research Site
Nahariya, 22100
Research Site
Nazareth, 16100
Research Site
Petah Tikva, 49100
Research Site
Ramat Gan, 52621
Research Site
Tel Aviv, 62748
Research Site
Tel Aviv, 6423906
United Kingdom12 sites
Research Site
Birmingham, B9 5SS
Research Site
Cardiff, CF14 2TL
Research Site
Colchester, CO4 5JL
Research Site
London, NW3 2QG
Research Site
London, SE1 9RT
Research Site
London, SW17 0QT
Research Site
London, SW3 6JJ
Research Site
London, W6 8RF
Research Site
Manchester, M20 4BX
Research Site
Nottingham, NG5 1PB
Research Site
Poole, BH15 2JB
Research Site
Stoke-on-Trent, ST4 6QG
Switzerland7 sites
Research Site
Altdorf, CH-6460
Research Site
Bülach, 8180
Research Site
Chur, CH-7000
Research Site
Fribourg, 1700
Research Site
Geneva, 1205
Research Site
Lausanne, 1011
Research Site
Neuchâtel, 2000
Norway4 sites
Research Site
Arendal, 4809
Research Site
Drammen, 3004
Research Site
Oslo, 450
Research Site
Tromsø, 9038
About this study
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.
Read the detailed description
This is a non-interventional/observational study including unresectable Stage III NSCLC patients treated with durvalumab. Patients will be selected from the following participating countries: Australia, Belgium, Israel, Netherlands, Norway, France, Germany, Italy, Switzerland, Spain* and the United Kingdom.
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
- NSCLC
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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 events of special interest assessed in the study included the following:
- Diarrhoea / colitis and intestinal perforation
- Pneumonitis / ILD
- Hepatitis / transaminase increases
- Endocrinopathies (i.e., events of hypophysitis / hypopituitarism, adrenal insufficiency, hyper- and hypo-thyroidism and type I diabetes mellitus)
- Rash / dermatitis
- Nephritis / blood creatinine increases
- Pancreatitis / serum lipase and amylase increases
- Myocarditis
- Myositis / polymyositis
- Neuropathy / neuromuscular toxicity (Guillain-Barré, and myasthenia gravis)
- Other inflammatory responses that are rare / less frequent with a potential immune-mediated aetiology include, but are not limited to, pericarditis, sarcoidosis, uveitis, and other events involving the eye, skin, haematological and rheumatological events.
Measured: 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
Time to death or DM was defined as time from the index date (D first dose date) to DM or death (if no DM).
Measured: 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
Time to death or LR is defined as time from the index date (D first dose date) to LR or death (if no LR).
Measured: 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
Time to first ST or death is defined as time from the index date (D first dose date) to the first ST or death (if no ST).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start19 Dec 2018
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798535
- Sponsor's protocol ID
- D4194R00005
- Status last verified
- Jul 2025
- First submitted
- 21 Dec 2018
- Last updated
- 16 Jul 2025
- Results posted
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37476372Zhao 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.
PubMed 36990576Girard 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.
PubMed 36307040
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT03798535
- Acronym / sponsor ID
- D4194R00005
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,156 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-interventional/observational study including unresectable Stage III NSCLC patients treated with durvalumab. Patients will be selected from the following participating countries: Australia, Belgium, Israel, Netherlands, Norway, France, Germany, Italy, Switzerland, Spain* and the United Kingdom.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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).
- Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met.
Key exclusion criteria (1 listed)
- -Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-world progression free survival (rwPFS)
Time frame: 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.
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).
Overall survival (OS)
Time frame: 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.
OS defined as time from the index date (D first dose date) to the date of death.
4 secondary outcomes
Adverse events of special interest
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 37476372Langberg 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.
- Derived from this study: PubMed 36990576Zhao 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.
- Derived from this study: PubMed 36307040Girard 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.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
254 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by AstraZeneca at 254 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 254 sites in France, Italy, Australia, Germany, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world progression free survival (rwPFS) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798535, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.