Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04303780
Registration number
NCT04303780
Ethics application status
Date submitted
5/03/2020
Date registered
11/03/2020
Titles & IDs
Public title
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Query!
Scientific title
A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Query!
Secondary ID [1]
0
0
2023-508214-42-00
Query!
Secondary ID [2]
0
0
20190009
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
KRAS p, G12c Mutated /Advanced Metastatic NSCLC
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - AMG 510
Treatment: Drugs - Docetaxel
Experimental: AMG 510 -
Active comparator: Docetaxel -
Treatment: Drugs: AMG 510
21 day cycles
Treatment: Drugs: Docetaxel
21 day cycles
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [1]
0
0
PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
Query!
Timepoint [1]
0
0
Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months
Query!
Eligibility
Key inclusion criteria
* Men or women greater than or equal to 18 years old.
* ECOG = 1
* Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
100
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Active brain metastases
* Myocardial infarction within 6 months of study day 1
* Gastrointestinal (GI) tract disease causing the inability to take oral medication
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/06/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
27/04/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
345
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Blacktown Hospital - Blacktown
Query!
Recruitment hospital [2]
0
0
Chris OBrien Lifehouse - Camperdown
Query!
Recruitment hospital [3]
0
0
St George Hospital - Kogarah
Query!
Recruitment hospital [4]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [5]
0
0
Prince Charles Hospital - Chermside
Query!
Recruitment hospital [6]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [7]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [8]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [9]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [10]
0
0
St John of God Healthcare - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [5]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [6]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [7]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [8]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [9]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [10]
0
0
6008 - Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Delaware
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Brussels
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Bruxelles
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Charleroi
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Edegem
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Gent
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Leuven
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Liege
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Roeselare
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Sint-Niklaas
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Rio Grande Do Sul
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
São Paulo
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Rio de Janeiro
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Alberta
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Ontario
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Quebec
Query!
Country [42]
0
0
Denmark
Query!
State/province [42]
0
0
Herlev
Query!
Country [43]
0
0
Denmark
Query!
State/province [43]
0
0
København
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
Odense C
Query!
Country [45]
0
0
Finland
Query!
State/province [45]
0
0
Helsinki
Query!
Country [46]
0
0
Finland
Query!
State/province [46]
0
0
Oulu
Query!
Country [47]
0
0
Finland
Query!
State/province [47]
0
0
Turku
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Brest
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Créteil
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Grenoble
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Lille Cedex
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Limoges Cedex
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Lyon
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Marseille Cedex 20
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Paris Cedex 20
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Paris
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Pessac Cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Pierre-Benite cedex
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Rennes
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Saint Herblain
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Strasbourg cedex
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Toulouse Cedex 9
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Villejuif
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Berlin
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Dresden
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Essen
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Esslingen am Neckar
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Frankfurt am Main
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Gauting
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Grosshansdorf
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Hamburg
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Heidelberg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Immenstadt
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Köln
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Leipzig
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Moers
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Oldenburg
Query!
Country [78]
0
0
Greece
Query!
State/province [78]
0
0
Athens
Query!
Country [79]
0
0
Greece
Query!
State/province [79]
0
0
Heraklion - Crete
Query!
Country [80]
0
0
Greece
Query!
State/province [80]
0
0
Larissa
Query!
Country [81]
0
0
Greece
Query!
State/province [81]
0
0
Patra
Query!
Country [82]
0
0
Greece
Query!
State/province [82]
0
0
Thessaloniki
Query!
Country [83]
0
0
Hungary
Query!
State/province [83]
0
0
Budapest
Query!
Country [84]
0
0
Hungary
Query!
State/province [84]
0
0
Farkasgyepu
Query!
Country [85]
0
0
Hungary
Query!
State/province [85]
0
0
Gyula
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Kaposvar
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Miskolc
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Szekesfehervar
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Tatabanya
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Torokbalint
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Avellino
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Bari
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Bologna
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Catania
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Firenze
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Milano
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Monserrato CA
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Monza (MB)
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Napoli
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Orbassano (TO)
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Padova
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Ravenna
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Roma
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Aichi
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Chiba
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Ehime
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Fukuoka
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Hiroshima
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Hokkaido
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Hyogo
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Ishikawa
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Kanagawa
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Kyoto
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Miyagi
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Niigata
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Okayama
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Osaka
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Saga
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Saitama
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Shiga
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Tokyo
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Tottori
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Wakayama
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Yamaguchi
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Cheongju-si, Chungcheongbuk-do
Query!
Country [126]
0
0
Korea, Republic of
Query!
State/province [126]
0
0
Goyang-si Gyeonggi-do
Query!
Country [127]
0
0
Korea, Republic of
Query!
State/province [127]
0
0
Seongnam-si, Gyeonggi-do
Query!
Country [128]
0
0
Korea, Republic of
Query!
State/province [128]
0
0
Seoul
Query!
Country [129]
0
0
Korea, Republic of
Query!
State/province [129]
0
0
Ulsan
Query!
Country [130]
0
0
Netherlands
Query!
State/province [130]
0
0
Amsterdam
Query!
Country [131]
0
0
Netherlands
Query!
State/province [131]
0
0
Groningen
Query!
Country [132]
0
0
Netherlands
Query!
State/province [132]
0
0
Nijmegen
Query!
Country [133]
0
0
Netherlands
Query!
State/province [133]
0
0
Rotterdam
Query!
Country [134]
0
0
Netherlands
Query!
State/province [134]
0
0
Utrecht
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Gdansk
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Lublin
Query!
Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Poznan
Query!
Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Warszawa
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Wroclaw
Query!
Country [140]
0
0
Portugal
Query!
State/province [140]
0
0
Lisboa
Query!
Country [141]
0
0
Portugal
Query!
State/province [141]
0
0
Matosinhos
Query!
Country [142]
0
0
Portugal
Query!
State/province [142]
0
0
Porto
Query!
Country [143]
0
0
Russian Federation
Query!
State/province [143]
0
0
Moscow
Query!
Country [144]
0
0
Russian Federation
Query!
State/province [144]
0
0
Nizhniy Novgorod
Query!
Country [145]
0
0
Russian Federation
Query!
State/province [145]
0
0
Omsk
Query!
Country [146]
0
0
Russian Federation
Query!
State/province [146]
0
0
Saint-Petersburg
Query!
Country [147]
0
0
Spain
Query!
State/province [147]
0
0
AndalucÃ-a
Query!
Country [148]
0
0
Spain
Query!
State/province [148]
0
0
Canarias
Query!
Country [149]
0
0
Spain
Query!
State/province [149]
0
0
Cataluña
Query!
Country [150]
0
0
Spain
Query!
State/province [150]
0
0
Comunidad Valenciana
Query!
Country [151]
0
0
Spain
Query!
State/province [151]
0
0
Galicia
Query!
Country [152]
0
0
Spain
Query!
State/province [152]
0
0
Madrid
Query!
Country [153]
0
0
Sweden
Query!
State/province [153]
0
0
Gavle
Query!
Country [154]
0
0
Sweden
Query!
State/province [154]
0
0
Goteborg
Query!
Country [155]
0
0
Sweden
Query!
State/province [155]
0
0
Linkoping
Query!
Country [156]
0
0
Sweden
Query!
State/province [156]
0
0
Lund
Query!
Country [157]
0
0
Sweden
Query!
State/province [157]
0
0
Stockholm
Query!
Country [158]
0
0
Sweden
Query!
State/province [158]
0
0
Umea
Query!
Country [159]
0
0
Switzerland
Query!
State/province [159]
0
0
Basel
Query!
Country [160]
0
0
Switzerland
Query!
State/province [160]
0
0
Bern
Query!
Country [161]
0
0
Switzerland
Query!
State/province [161]
0
0
Geneve
Query!
Country [162]
0
0
Switzerland
Query!
State/province [162]
0
0
Lausanne
Query!
Country [163]
0
0
Switzerland
Query!
State/province [163]
0
0
Winterthur
Query!
Country [164]
0
0
Switzerland
Query!
State/province [164]
0
0
Zurich
Query!
Country [165]
0
0
Taiwan
Query!
State/province [165]
0
0
Taichung
Query!
Country [166]
0
0
Taiwan
Query!
State/province [166]
0
0
Tainan
Query!
Country [167]
0
0
Taiwan
Query!
State/province [167]
0
0
Taipei
Query!
Country [168]
0
0
United Kingdom
Query!
State/province [168]
0
0
Cambridge
Query!
Country [169]
0
0
United Kingdom
Query!
State/province [169]
0
0
Edinburgh
Query!
Country [170]
0
0
United Kingdom
Query!
State/province [170]
0
0
London
Query!
Country [171]
0
0
United Kingdom
Query!
State/province [171]
0
0
Manchester
Query!
Country [172]
0
0
United Kingdom
Query!
State/province [172]
0
0
Nottingham
Query!
Country [173]
0
0
United Kingdom
Query!
State/province [173]
0
0
Oxford
Query!
Country [174]
0
0
United Kingdom
Query!
State/province [174]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Amgen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Query!
Trial website
https://clinicaltrials.gov/study/NCT04303780
Query!
Trial related presentations / publications
de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, Wolf J, Schuler M, Lena H, Skoulidis F, Yoneshima Y, Kim SW, Linardou H, Novello S, van der Wekken AJ, Chen Y, Peters S, Felip E, Solomon BJ, Ramalingam SS, Dooms C, Lindsay CR, Ferreira CG, Blais N, Obiozor CC, Wang Y, Mehta B, Varrieur T, Ngarmchamnanrith G, Stollenwerk B, Waterhouse D, Paz-Ares L; CodeBreaK 200 Investigators. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. Lancet. 2023 Mar 4;401(10378):733-746. doi: 10.1016/S0140-6736(23)00221-0. Epub 2023 Feb 7.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study
Query!
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/80/NCT04303780/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/80/NCT04303780/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04303780