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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03798535
Collaborator
(none)
1,159
Enrollment
254
Locations
60
Anticipated Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab.

The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain

    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 stage III unresectable NSCLC and the durvalumab start date (index date).

    • The second chart extraction will be triggered at time of estimated maturity of PFS data to provide an accurate measure of the PFS outcome.

    • The third chart extraction will be triggered at time of estimated maturity of OS data to provide an accurate measure of the OS outcome• The fourth and fifth chart extractions will occur approximately 3-years and 5-years after enrolment

    • The dates for the second through fifth 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) and any available data on PFS and OS observed in the first extraction together with the distribution of PFS and OS observed in the PACIFIC trial.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1159 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
    Actual Study Start Date :
    Dec 19, 2018
    Anticipated Primary Completion Date :
    Dec 20, 2023
    Anticipated Study Completion Date :
    Dec 20, 2023

    Outcome Measures

    Primary Outcome Measures

    1. To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS) [PFS is assessed as PFS rates at 12 months and 18 months, and as PFS median for a period of time of 5 years. From Index date (first dose of durvalumab) to progression or death whichever came first, assessed up to 5 years.]

      PFS defined as time from the index date (date of the first dose of durvalumab) to the date of investigator-determined disease progression or death (if no progression) or the end of follow-up

    2. To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS) [OS is assessed as OS rates at 2, 3 and 5 years, and as OS median for a period of time of 5 years. From Index date (first dose of durvalumab) to death or end of follow up, whichever came first, assessed during 5 years.]

      OS following durvalumab regimen received from the index date to death or end of follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Ballarat Australia 3350
    2 Research Site Bankstown Australia 2200
    3 Research Site Bedford Park Australia 5042
    4 Research Site Bendigo Australia 3550
    5 Research Site Bentleigh East Australia 3165
    6 Research Site Bowral Australia 2576
    7 Research Site Box Hill Australia 3128
    8 Research Site Campbelltown Australia 2560
    9 Research Site Camperdown Australia 2050
    10 Research Site Canberra Australia 2605
    11 Research Site Clayton Australia 3168
    12 Research Site Coffs Harbour Australia 2450
    13 Research Site Douglas Australia 4814
    14 Research Site Elizabeth Vale Australia 5112
    15 Research Site Frankston Australia 3199
    16 Research Site Hamlyn Terrace Australia 2259
    17 Research Site Hervey Bay Australia 4655
    18 Research Site Hobart Australia 7000
    19 Research Site Joondalup Australia 6027
    20 Research Site Kingswood Australia 2747
    21 Research Site Liverpool Australia 2170
    22 Research Site Malvern Australia 3144
    23 Research Site Melbourne Australia 3000
    24 Research Site Melbourne Australia 3004
    25 Research Site Murdoch Australia 6150
    26 Research Site Orange Australia 2800
    27 Research Site Rockhampton Australia 4700
    28 Research Site St Leonards Australia 2065
    29 Research Site Subiaco Australia 6008
    30 Research Site Traralgon Australia 3844
    31 Research Site Tugun Australia 4224
    32 Research Site Warrnambool Australia 3280
    33 Research Site Wendouree Australia 3355
    34 Research Site Westmead Australia 2145
    35 Research Site Wollongong Australia 2500
    36 Research Site Aalst Belgium 9300
    37 Research Site Bouge Belgium 5004
    38 Research Site Braine-l'Alleud Belgium 1420
    39 Research Site Brasschaat Belgium 2930
    40 Research Site Brussels Belgium 1000
    41 Research Site Brussels Belgium 1090
    42 Research Site Bruxelles Belgium 1200
    43 Research Site Dendermonde Belgium 9200
    44 Research Site Gent Belgium 9000
    45 Research Site Hasselt Belgium 3500
    46 Research Site Herstal Belgium 4040
    47 Research Site Heusden-Zolder Belgium 3550
    48 Research Site Ieper Belgium 8900
    49 Research Site Kuringen Belgium 2820
    50 Research Site Liège Belgium 4000
    51 Research Site Loverval Belgium 6280
    52 Research Site Mons Belgium 7000
    53 Research Site Ottignies Belgium 1340
    54 Research Site Roeselare Belgium 8800
    55 Research Site Ronse Belgium 9600
    56 Research Site Sint-Niklaas Belgium 9100
    57 Research Site Sint-Truiden Belgium 3800
    58 Research Site Yvoir Belgium 5530
    59 Research Site Abbeville France 80100
    60 Research Site Aix en Provence France 13100
    61 Research Site Albi Cedex 09 France 81013
    62 Research Site Antony France 92160
    63 Research Site Avignon Cedex 09 France 84918
    64 Research Site Bayonne France 64100
    65 Research Site Bethune Cedex France 62408
    66 Research Site Beziers France 34500
    67 Research Site Bobigny cedex France 93009
    68 Research Site Bordeaux France 33030
    69 Research Site Bordeaux France 33300
    70 Research Site Boulogne Billancourt Cedex France 92104
    71 Research Site Brest Cedex France 29609
    72 Research Site Carcassonne Cedex France 11010
    73 Research Site Chauny France 02303
    74 Research Site Clermont-Ferrand France 63000
    75 Research Site Colmar France 68024
    76 Research Site Contamine sur Arve France 74130
    77 Research Site Creteil Cedex France 94010
    78 Research Site Dijon cedex France 21033
    79 Research Site Dijon cedex France 21079
    80 Research Site GAP Cedex France 5007
    81 Research Site Grenoble France 38700
    82 Research Site La Roche sur Yon Cedex 9 France 85925
    83 Research Site La Rochelle Cedex France 17019
    84 Research Site Le Mans Cedex France 72037
    85 Research Site Levallois-Perret France 92300
    86 Research Site Libourne Cedex France 33505
    87 Research Site Lille France 59037
    88 Research Site Limoges France 87000
    89 Research Site Lorient France 56322
    90 Research Site Lyon Cedex 08 France 69373
    91 Research Site Macon France 71018
    92 Research Site MARSEILLE Cedex 20 France 13015
    93 Research Site Marseille France 13003
    94 Research Site Metz-Tessy France 74370
    95 Research Site Montpellier France 34070
    96 Research Site Montpellier France 34298
    97 Research Site Morlaix Cedex France 29572
    98 Research Site Muret France
    99 Research Site Nancy France 54100
    100 Research Site Nîmes France 30029
    101 Research Site Paris Cedex 10 France 75475
    102 Research Site Paris Cedex 14 France 75014
    103 Research Site Paris Cedex 5 France 75005
    104 Research Site Paris France 75018
    105 Research Site Paris France 75020
    106 Research Site Pau cedex France 6400
    107 Research Site Perigueux France 24000
    108 Research Site Perpignan France 66046
    109 Research Site Pierre Benite Cedex France 69495
    110 Research Site Poitiers France 86021
    111 Research Site Rennes Cedex 9 France 35033
    112 Research Site Rouen Cedex France 76031
    113 Research Site Saint Nazaire Cedex France 44606
    114 Research Site Saint Priest en Jarez France 42270
    115 Research Site Saint-Aubin-lès-Elbeuf France 76410
    116 Research Site Saint-Quentin cedex France 02321
    117 Research Site Tarbes France 65000
    118 Research Site Toulon cedex 9 France 83041
    119 Research Site Toulouse France 31059
    120 Research Site Tours cedex France 37044
    121 Research Site Valence France 26000
    122 Research Site Vantoux France 57070
    123 Research Site Villefranche-sur-Saône cedex France 69400
    124 Research Site Berlin Germany 12351
    125 Research Site Bochum Germany 44791
    126 Research Site Bremen Germany 28205
    127 Research Site Dresden Germany 1307
    128 Research Site Erlangen Germany 91054
    129 Research Site Essen Germany 45136
    130 Research Site Esslingen Germany 73730
    131 Research Site Fürth Germany 90766
    132 Research Site Georgsmarienhuette Germany 49124
    133 Research Site Gütersloh Germany 33334
    134 Research Site Halle (Saale) Germany 06120
    135 Research Site Hamburg Germany 20246
    136 Research Site Hamburg Germany 20249
    137 Research Site Hamburg Germany 21075
    138 Research Site Immenhausen Germany 34376
    139 Research Site Kaiserslautern Germany 67655
    140 Research Site Karlsruhe Germany 76137
    141 Research Site Kempten Germany 87439
    142 Research Site Muenchen Germany 80336
    143 Research Site Münnerstadt Germany 97702
    144 Research Site Oldenburg Germany 26121
    145 Research Site Paderborn Germany 33098
    146 Research Site Recklinghausen Germany 45657
    147 Research Site Regensburg Germany 93049
    148 Research Site Regensburg Germany 93053
    149 Research Site Rostock Germany 18057
    150 Research Site Würselen Germany 52146
    151 Research Site Ashkelon Israel 78278
    152 Research Site Beer Sheva Israel 8410101
    153 Research Site Haifa Israel 34362
    154 Research Site Haifa Israel 91096
    155 Research Site Holon Israel 58100
    156 Research Site Jerusalem Israel 9112001
    157 Research Site Kfar-Saba Israel 4428164
    158 Research Site Nahariya Israel 22100
    159 Research Site Nazareth Israel 16100
    160 Research Site Petah Tikva Israel 49100
    161 Research Site Ramat Gan Israel 52621
    162 Research Site Tel Aviv Israel 62748
    163 Research Site Tel Aviv Israel 6423906
    164 Research Site Alessandria Italy 15100
    165 Research Site Ancona Italy 60122
    166 Research Site Arezzo Italy 52100
    167 Research Site Aviano Italy 33081
    168 Research Site Bari Italy 70124
    169 Research Site Bolzano Italy 39100
    170 Research Site Brescia Italy 25100
    171 Research Site Brescia Italy 25123
    172 Research Site Catanzaro Italy 88100
    173 Research Site Feltre Italy 32032
    174 Research Site Firenze Italy 50141
    175 Research Site Genova Italy 16121
    176 Research Site Genova Italy 16132
    177 Research Site Imola Italy 40026
    178 Research Site l'Aquila (AQ) Italy 67100
    179 Research Site La Spezia Italy 19124
    180 Research Site Lecce Italy 73100
    181 Research Site Lido di Camaiore Italy 55041
    182 Research Site Meldola Italy 47014
    183 Research Site Messina Italy 98158
    184 Research Site Milano Italy 20132
    185 Research Site Milano Italy 20133
    186 Research Site Milano Italy 20141
    187 Research Site Mirano Italy 30035
    188 Research Site Modena Italy 41124
    189 Research Site Monza Italy 20900
    190 Research Site Napoli Italy 80131
    191 Research Site Padova Italy 35128
    192 Research Site Parma Italy 43126
    193 Research Site Pavia Italy 27100
    194 Research Site Perugia Italy 06132
    195 Research Site Pisa Italy 56124
    196 Research Site Pistoia Italy 51100
    197 Research Site Ravenna Italy 48121
    198 Research Site Reggio Emilia Italy 42100
    199 Research Site Rimini Italy 47923
    200 Research Site Rionero In Vulture (PZ) Italy 85028
    201 Research Site Roma Italy 00161
    202 Research Site Roma Italy 00189
    203 Research Site Rozzano Italy 20089
    204 Research Site Sora Italy 03039
    205 Research Site Terni Italy 05100
    206 Research Site Treviglio Italy 24047
    207 Research Site Trieste Italy 34100
    208 Research Site Udine Italy 33100
    209 Research Site Varese Italy 21100
    210 Research Site Verona Italy 37124
    211 Research Site Alkmaar Netherlands 1815JD
    212 Research Site Amersfoort Netherlands 3813 TZ
    213 Research Site Amsterdam Netherlands 1066 CX
    214 Research Site Amsterdam Netherlands 1091 AC
    215 Research Site Arnhem Netherlands 6815 AD
    216 Research Site Breda Netherlands 4818 CK
    217 Research Site Den Haag Netherlands 2545 AA
    218 Research Site Ede Netherlands 6716 RP
    219 Research Site Eindhoven Netherlands 5631 BM
    220 Research Site Groningen Netherlands 9713 GZ
    221 Research Site Groningen Netherlands 9728 NT
    222 Research Site Heerlen Netherlands 6419 PC
    223 Research Site Hertogenbosch Netherlands 5223 GZ
    224 Research Site Hilversum Netherlands 1313 XZ
    225 Research Site Leiden Netherlands 2300 RC
    226 Research Site Maastricht Netherlands 6202 AZ
    227 Research Site Nieuwegein Netherlands 3430EM
    228 Research Site Nijmegen Netherlands 6525 GA
    229 Research Site Rotterdam Netherlands 3015 GD
    230 Research Site Utrecht Netherlands 3584 CX
    231 Research Site Zutphen Netherlands 7207 AE
    232 Research Site Arendal Norway 4809
    233 Research Site Drammen Norway 3004
    234 Research Site Oslo Norway 450
    235 Research Site Tromso Norway 9038
    236 Research Site Altdorf Switzerland CH-6460
    237 Research Site Bulach Switzerland 8180
    238 Research Site Chur Switzerland CH-7000
    239 Research Site Fribourg Switzerland 1700
    240 Research Site Geneva Switzerland 1205
    241 Research Site Lausanne Switzerland 1011
    242 Research Site Neuchâtel Switzerland 2000
    243 Research Site Birmingham United Kingdom B9 5SS
    244 Research Site Cardiff United Kingdom CF14 2TL
    245 Research Site Colchester United Kingdom CO4 5JL
    246 Research Site London United Kingdom NW3 2QG
    247 Research Site London United Kingdom SE1 9RT
    248 Research Site London United Kingdom SW17 0QT
    249 Research Site London United Kingdom SW3 6JJ
    250 Research Site London United Kingdom W6 8RF
    251 Research Site Manchester United Kingdom M20 4BX
    252 Research Site Nottingham United Kingdom NG5 1PB
    253 Research Site Poole United Kingdom BH15 2JB
    254 Research Site Stoke on Trent United Kingdom ST4 6QG

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03798535
    Other Study ID Numbers:
    • D4194R00005
    First Posted:
    Jan 10, 2019
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 18, 2022