First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

July 11, 2025 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Ballarat, Australia, 3350
        • Research Site
      • Bankstown, Australia, 2200
        • Research Site
      • Bedford Park, Australia, 5042
        • Research Site
      • Bendigo, Australia, 3550
        • Research Site
      • Bentleigh East, Australia, 3165
        • Research Site
      • Bowral, Australia, 2576
        • Research Site
      • Box Hill, Australia, 3128
        • Research Site
      • Campbelltown, Australia, 2560
        • Research Site
      • Camperdown, Australia, 2050
        • Research Site
      • Canberra, Australia, 2605
        • Research Site
      • Clayton, Australia, 3168
        • Research Site
      • Coffs Harbour, Australia, 2450
        • Research Site
      • Douglas, Australia, 4814
        • Research Site
      • Elizabeth Vale, Australia, 5112
        • Research Site
      • Frankston, Australia, 3199
        • Research Site
      • Hamlyn Terrace, Australia, 2259
        • Research Site
      • Hervey Bay, Australia, 4655
        • Research Site
      • Hobart, Australia, 7000
        • Research Site
      • Joondalup, Australia, 6027
        • Research Site
      • Kingswood, Australia, 2747
        • Research Site
      • Liverpool, Australia, 2170
        • Research Site
      • Malvern, Australia, 3144
        • Research Site
      • Melbourne, Australia, 3004
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
      • Murdoch, Australia, 6150
        • Research Site
      • Orange, Australia, 2800
        • Research Site
      • Rockhampton, Australia, 4700
        • Research Site
      • St Leonards, Australia, 2065
        • Research Site
      • Subiaco, Australia, 6008
        • Research Site
      • Traralgon, Australia, 3844
        • Research Site
      • Tugun, Australia, 4224
        • Research Site
      • Warrnambool, Australia, 3280
        • Research Site
      • Wendouree, Australia, 3355
        • Research Site
      • Westmead, Australia, 2145
        • Research Site
      • Wollongong, Australia, 2500
        • Research Site
  • Belgium
      • Aalst, Belgium, 9300
        • Research Site
      • Bouge, Belgium, 5004
        • Research Site
      • Braine-l'Alleud, Belgium, 1420
        • Research Site
      • Brasschaat, Belgium, 2930
        • Research Site
      • Brussels, Belgium, 1000
        • Research Site
      • Brussels, Belgium, 1090
        • Research Site
      • Bruxelles, Belgium, 1200
        • Research Site
      • Dendermonde, Belgium, 9200
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Hasselt, Belgium, 3500
        • Research Site
      • Herstal, Belgium, 4040
        • Research Site
      • Heusden-Zolder, Belgium, 3550
        • Research Site
      • Ieper, Belgium, 8900
        • Research Site
      • Kuringen, Belgium, 2820
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
      • Loverval, Belgium, 6280
        • Research Site
      • Mons, Belgium, 7000
        • Research Site
      • Ottignies, Belgium, 1340
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
      • Ronse, Belgium, 9600
        • Research Site
      • Sint-Niklaas, Belgium, 9100
        • Research Site
      • Sint-Truiden, Belgium, 3800
        • Research Site
      • Yvoir, Belgium, 5530
        • Research Site
  • France
      • Abbeville, France, 80100
        • Research Site
      • Aix en Provence, France, 13100
        • Research Site
      • Albi Cedex 09, France, 81013
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      • Antony, France, 92160
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      • Avignon Cedex 09, France, 84918
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      • Bayonne, France, 64100
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      • Bethune Cedex, France, 62408
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      • Beziers, France, 34500
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      • Bobigny cedex, France, 93009
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      • Bordeaux, France, 33030
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      • Bordeaux, France, 33300
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      • Boulogne Billancourt Cedex, France, 92104
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      • Brest Cedex, France, 29609
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      • Carcassonne Cedex, France, 11010
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      • Chauny, France, 02303
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      • Clermont-Ferrand, France, 63000
        • Research Site
      • Colmar, France, 68024
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      • Contamine sur Arve, France, 74130
        • Research Site
      • Creteil Cedex, France, 94010
        • Research Site
      • Dijon cedex, France, 21033
        • Research Site
      • Dijon cedex, France, 21079
        • Research Site
      • GAP Cedex, France, 5007
        • Research Site
      • Grenoble, France, 38700
        • Research Site
      • La Roche sur Yon Cedex 9, France, 85925
        • Research Site
      • La Rochelle Cedex, France, 17019
        • Research Site
      • Le Mans Cedex, France, 72037
        • Research Site
      • Levallois-Perret, France, 92300
        • Research Site
      • Libourne Cedex, France, 33505
        • Research Site
      • Lille, France, 59037
        • Research Site
      • Limoges, France, 87000
        • Research Site
      • Lorient, France, 56322
        • Research Site
      • Lyon Cedex 08, France, 69373
        • Research Site
      • MARSEILLE Cedex 20, France, 13015
        • Research Site
      • Macon, France, 71018
        • Research Site
      • Marseille, France, 13003
        • Research Site
      • Metz-Tessy, France, 74370
        • Research Site
      • Montpellier, France, 34298
        • Research Site
      • Montpellier, France, 34070
        • Research Site
      • Morlaix Cedex, France, 29572
        • Research Site
      • Muret, France
        • Research Site
      • Nancy, France, 54100
        • Research Site
      • Nimes, France, 30029
        • Research Site
      • Paris, France, 75018
        • Research Site
      • Paris, France, 75020
        • Research Site
      • Paris Cedex 10, France, 75475
        • Research Site
      • Paris Cedex 14, France, 75014
        • Research Site
      • Paris Cedex 5, France, 75005
        • Research Site
      • Pau cedex, France, 6400
        • Research Site
      • Perigueux, France, 24000
        • Research Site
      • Perpignan, France, 66046
        • Research Site
      • Pierre Benite Cedex, France, 69495
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Rennes Cedex 9, France, 35033
        • Research Site
      • Rouen Cedex, France, 76031
        • Research Site
      • Saint Nazaire Cedex, France, 44606
        • Research Site
      • Saint Priest en Jarez, France, 42270
        • Research Site
      • Saint-Aubin-les-Elbeuf, France, 76410
        • Research Site
      • Saint-Quentin cedex, France, 02321
        • Research Site
      • Tarbes, France, 65000
        • Research Site
      • Toulon cedex 9, France, 83041
        • Research Site
      • Toulouse, France, 31059
        • Research Site
      • Tours cedex, France, 37044
        • Research Site
      • Valence, France, 26000
        • Research Site
      • Vantoux, France, 57070
        • Research Site
      • Villefranche-sur-Saone cedex, France, 69400
        • Research Site
  • Germany
      • Berlin, Germany, 12351
        • Research Site
      • Bochum, Germany, 44791
        • Research Site
      • Bremen, Germany, 28205
        • Research Site
      • Dresden, Germany, 1307
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Essen, Germany, 45136
        • Research Site
      • Esslingen, Germany, 73730
        • Research Site
      • Furth, Germany, 90766
        • Research Site
      • Georgsmarienhütte, Germany, 49124
        • Research Site
      • Gutersloh, Germany, 33334
        • Research Site
      • Halle (Saale), Germany, 06120
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Hamburg, Germany, 21075
        • Research Site
      • Hamburg, Germany, 20249
        • Research Site
      • Immenhausen, Germany, 34376
        • Research Site
      • Kaiserslautern, Germany, 67655
        • Research Site
      • Karlsruhe, Germany, 76137
        • Research Site
      • Kempten, Germany, 87439
        • Research Site
      • Muenchen, Germany, 80336
        • Research Site
      • Munnerstadt, Germany, 97702
        • Research Site
      • Oldenburg, Germany, 26121
        • Research Site
      • Paderborn, Germany, 33098
        • Research Site
      • Recklinghausen, Germany, 45657
        • Research Site
      • Regensburg, Germany, 93053
        • Research Site
      • Regensburg, Germany, 93049
        • Research Site
      • Rostock, Germany, 18057
        • Research Site
      • Wurselen, Germany, 52146
        • Research Site
  • Israel
      • Ashkelon, Israel, 78278
        • Research Site
      • Beer Sheva, Israel, 8410101
        • Research Site
      • Haifa, Israel, 34362
        • Research Site
      • Haifa, Israel, 91096
        • Research Site
      • Holon, Israel, 58100
        • Research Site
      • Jerusalem, Israel, 9112001
        • Research Site
      • Kfar-Saba, Israel, 4428164
        • Research Site
      • Nahariya, Israel, 22100
        • Research Site
      • Nazareth, Israel, 16100
        • Research Site
      • Petah Tikva, Israel, 49100
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
      • Tel Aviv, Israel, 62748
        • Research Site
      • Tel Aviv, Israel, 6423906
        • Research Site
  • Italy
      • Alessandria, Italy, 15100
        • Research Site
      • Ancona, Italy, 60122
        • Research Site
      • Arezzo, Italy, 52100
        • Research Site
      • Aviano, Italy, 33081
        • Research Site
      • Bari, Italy, 70124
        • Research Site
      • Bolzano, Italy, 39100
        • Research Site
      • Brescia, Italy, 25123
        • Research Site
      • Brescia, Italy, 25100
        • Research Site
      • Catanzaro, Italy, 88100
        • Research Site
      • Feltre, Italy, 32032
        • Research Site
      • Firenze, Italy, 50141
        • Research Site
      • Genova, Italy, 16132
        • Research Site
      • Genova, Italy, 16121
        • Research Site
      • Imola, Italy, 40026
        • Research Site
      • L'Aquila, Italy, 67100
        • Research Site
      • La Spezia, Italy, 19124
        • Research Site
      • Lecce, Italy, 73100
        • Research Site
      • Lido di Camaiore, Italy, 55041
        • Research Site
      • Meldola, Italy, 47014
        • Research Site
      • Messina, Italy, 98158
        • Research Site
      • Milano, Italy, 20141
        • Research Site
      • Milano, Italy, 20132
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      • Milano, Italy, 20133
        • Research Site
      • Mirano, Italy, 30035
        • Research Site
      • Modena, Italy, 41124
        • Research Site
      • Monza, Italy, 20900
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Parma, Italy, 43126
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Perugia, Italy, 06132
        • Research Site
      • Pisa, Italy, 56124
        • Research Site
      • Pistoia, Italy, 51100
        • Research Site
      • Ravenna, Italy, 48121
        • Research Site
      • Reggio Emilia, Italy, 42100
        • Research Site
      • Rimini, Italy, 47923
        • Research Site
      • Rionero in Vulture, Italy, 85028
        • Research Site
      • Roma, Italy, 00189
        • Research Site
      • Roma, Italy, 00161
        • Research Site
      • Rozzano, Italy, 20089
        • Research Site
      • Sora, Italy, 03039
        • Research Site
      • Terni, Italy, 05100
        • Research Site
      • Treviglio, Italy, 24047
        • Research Site
      • Trieste, Italy, 34100
        • Research Site
      • Udine, Italy, 33100
        • Research Site
      • Varese, Italy, 21100
        • Research Site
      • Verona, Italy, 37124
        • Research Site
  • Netherlands
      • Alkmaar, Netherlands, 1815JD
        • Research Site
      • Amersfoort, Netherlands, 3813 TZ
        • Research Site
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1091 AC
        • Research Site
      • Arnhem, Netherlands, 6815 AD
        • Research Site
      • Breda, Netherlands, 4818 CK
        • Research Site
      • Den Haag, Netherlands, 2545 AA
        • Research Site
      • Ede, Netherlands, 6716 RP
        • Research Site
      • Eindhoven, Netherlands, 5631 BM
        • Research Site
      • Groningen, Netherlands, 9713 GZ
        • Research Site
      • Groningen, Netherlands, 9728 NT
        • Research Site
      • Heerlen, Netherlands, 6419 PC
        • Research Site
      • Hertogenbosch, Netherlands, 5223 GZ
        • Research Site
      • Hilversum, Netherlands, 1313 XZ
        • Research Site
      • Leiden, Netherlands, 2300 RC
        • Research Site
      • Maastricht, Netherlands, 6202 AZ
        • Research Site
      • Nieuwegein, Netherlands, 3430EM
        • Research Site
      • Nijmegen, Netherlands, 6525 GA
        • Research Site
      • Rotterdam, Netherlands, 3015 GD
        • Research Site
      • Utrecht, Netherlands, 3584 CX
        • Research Site
      • Zutphen, Netherlands, 7207 AE
        • Research Site
  • Norway
      • Arendal, Norway, 4809
        • Research Site
      • Drammen, Norway, 3004
        • Research Site
      • Oslo, Norway, 450
        • Research Site
      • Tromso, Norway, 9038
        • Research Site
  • Switzerland
      • Altdorf, Switzerland, CH-6460
        • Research Site
      • Bulach, Switzerland, 8180
        • Research Site
      • Chur, Switzerland, CH-7000
        • Research Site
      • Fribourg, Switzerland, 1700
        • Research Site
      • Geneva, Switzerland, 1205
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
      • Neuchatel, Switzerland, 2000
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Research Site
      • Cardiff, United Kingdom, CF14 2TL
        • Research Site
      • Colchester, United Kingdom, CO4 5JL
        • Research Site
      • London, United Kingdom, W6 8RF
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • London, United Kingdom, SW17 0QT
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Poole, United Kingdom, BH15 2JB
        • Research Site
      • Stoke on Trent, United Kingdom, ST4 6QG
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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)
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).

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.
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 DM was defined as time from the index date (D first dose date) to DM or death (if no DM).
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 death or LR is defined as time from the index date (D first dose date) to LR or death (if no LR).
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.
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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

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Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4194R00005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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