Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT05920356




Registration number
NCT05920356
Ethics application status
Date submitted
23/05/2023
Date registered
27/06/2023

Titles & IDs
Public title
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Scientific title
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
Secondary ID [1] 0 0
2022-501863-41
Secondary ID [2] 0 0
20190341
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sotorasib
Treatment: Drugs - Pembrolizumab

Experimental: Sotorasib combined with carboplatin and pemetrexed - Sotorasib administered in combination with carboplatin and pemetrexed.

Active comparator: Pembrolizumab combined with carboplatin and pemetrexed - Pembrolizumab administered in combination with carboplatin and pemetrexed.


Treatment: Drugs: Sotorasib
Oral administration

Treatment: Drugs: Pembrolizumab
Intravenous administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
From Baseline up to end of study (EOS) (approximately 5.5 years)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [3] 0 0
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score
Timepoint [3] 0 0
From Baseline to Week 12
Secondary outcome [4] 0 0
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale
Timepoint [4] 0 0
From Baseline to Week 12
Secondary outcome [5] 0 0
Change in QLQ-LC13 Symptoms of Cough Subscale
Timepoint [5] 0 0
From Baseline to Week 12
Secondary outcome [6] 0 0
Change in QLQ-LC13 Symptoms of Chest Pain Subscale
Timepoint [6] 0 0
From Baseline to Week 12
Secondary outcome [7] 0 0
Change in Physical Function as Measured by QLQ-C30
Timepoint [7] 0 0
From Baseline to Week 12
Secondary outcome [8] 0 0
Change in Global Health Status as Measured by QLQ-C30
Timepoint [8] 0 0
From Baseline to Week 12
Secondary outcome [9] 0 0
Progression-free Survival 2 (PFS2)
Timepoint [9] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [10] 0 0
Change in QLQ-LC13 Subscale Scores
Timepoint [10] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [11] 0 0
Change in QLQ-C30 Subscale Scores
Timepoint [11] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [12] 0 0
Time to Deterioration in QLC-LC13 Subscale Scores
Timepoint [12] 0 0
From Baseline to Week 12
Secondary outcome [13] 0 0
Time to Deterioration in QLC-C30 Subscale Scores
Timepoint [13] 0 0
From Baseline to Week 12
Secondary outcome [14] 0 0
Change in Summary Scores and Visual Analogue Scale (VAS) Scores
Timepoint [14] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [15] 0 0
Duration of Response
Timepoint [15] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [16] 0 0
Time to Response
Timepoint [16] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [17] 0 0
Disease Control
Timepoint [17] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [18] 0 0
PFS
Timepoint [18] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [19] 0 0
Objective Response
Timepoint [19] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [20] 0 0
Number of Participants With Treatment-Emergent Adverse Events
Timepoint [20] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [21] 0 0
Number of Participants With Clinically Significant Changes in Vital Signs
Timepoint [21] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [22] 0 0
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests
Timepoint [22] 0 0
From Baseline up to EOS (approximately 5.5 years)
Secondary outcome [23] 0 0
Maximum Plasma Concentration (Cmax) of Sotorasib
Timepoint [23] 0 0
Pre-dose Day 1 up to Day 64
Secondary outcome [24] 0 0
Minimum Plasma Concentration (Cmin) of Sotorasib
Timepoint [24] 0 0
Pre-dose Day 1 up to Day 64
Secondary outcome [25] 0 0
Area Under The Curve (AUC) of Sotorasib
Timepoint [25] 0 0
Pre-dose Day 1 up to Day 64

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
* No history of systemic anticancer therapy in metastatic/non-curable settings
* Eastern Cooperative Oncology Group (ECOG) = 1
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved
* Symptomatic (treated or untreated) brain metastases
* Gastrointestinal (GI) tract disease causing the inability to take oral medication
* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
* Prior therapy with a KRAS G12C inhibitor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Nepean Cancer Centre - Kingswood
Recruitment hospital [4] 0 0
GenesisCare -North Shore Oncology - St Leonards
Recruitment hospital [5] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [6] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
4350 - Toowoomba
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
New Mexico
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Jujuy
Country [11] 0 0
Argentina
State/province [11] 0 0
Río Negro
Country [12] 0 0
Argentina
State/province [12] 0 0
Santa Fe
Country [13] 0 0
Argentina
State/province [13] 0 0
La Rioja
Country [14] 0 0
Argentina
State/province [14] 0 0
Salta
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Austria
State/province [16] 0 0
Klagenfurt
Country [17] 0 0
Austria
State/province [17] 0 0
Krems
Country [18] 0 0
Austria
State/province [18] 0 0
Salzburg
Country [19] 0 0
Austria
State/province [19] 0 0
Wels
Country [20] 0 0
Belgium
State/province [20] 0 0
Auderghem
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Belgium
State/province [23] 0 0
Liège
Country [24] 0 0
Belgium
State/province [24] 0 0
Mechelen
Country [25] 0 0
Brazil
State/province [25] 0 0
Distrito Federal
Country [26] 0 0
Brazil
State/province [26] 0 0
Espírito Santo
Country [27] 0 0
Brazil
State/province [27] 0 0
Minas Gerais
Country [28] 0 0
Brazil
State/province [28] 0 0
Pará
Country [29] 0 0
Brazil
State/province [29] 0 0
Pernambuco
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio Grande Do Sul
Country [31] 0 0
Brazil
State/province [31] 0 0
Santa Catarina
Country [32] 0 0
Brazil
State/province [32] 0 0
São Paulo
Country [33] 0 0
Brazil
State/province [33] 0 0
Rio de Janeiro
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Panagyurishte
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Pleven
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Sofia
Country [37] 0 0
Canada
State/province [37] 0 0
Nova Scotia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Canada
State/province [40] 0 0
Saskatchewan
Country [41] 0 0
Chile
State/province [41] 0 0
Cautín
Country [42] 0 0
Chile
State/province [42] 0 0
Santiago
Country [43] 0 0
Chile
State/province [43] 0 0
Talca
Country [44] 0 0
China
State/province [44] 0 0
Anhui
Country [45] 0 0
China
State/province [45] 0 0
Fujian
Country [46] 0 0
China
State/province [46] 0 0
Gansu
Country [47] 0 0
China
State/province [47] 0 0
Guangdong
Country [48] 0 0
China
State/province [48] 0 0
Guangxi
Country [49] 0 0
China
State/province [49] 0 0
Hainan
Country [50] 0 0
China
State/province [50] 0 0
Hebei
Country [51] 0 0
China
State/province [51] 0 0
Henan
Country [52] 0 0
China
State/province [52] 0 0
Hubei
Country [53] 0 0
China
State/province [53] 0 0
Hunan
Country [54] 0 0
China
State/province [54] 0 0
Jiangsu
Country [55] 0 0
China
State/province [55] 0 0
Jiangxi
Country [56] 0 0
China
State/province [56] 0 0
Jilin
Country [57] 0 0
China
State/province [57] 0 0
Shandong
Country [58] 0 0
China
State/province [58] 0 0
Shanxi
Country [59] 0 0
China
State/province [59] 0 0
Sichuan
Country [60] 0 0
China
State/province [60] 0 0
Zhejiang
Country [61] 0 0
China
State/province [61] 0 0
Beijing
Country [62] 0 0
Colombia
State/province [62] 0 0
Antioquia
Country [63] 0 0
Colombia
State/province [63] 0 0
Cesar
Country [64] 0 0
Colombia
State/province [64] 0 0
Cundinamarca
Country [65] 0 0
Colombia
State/province [65] 0 0
Córdoba
Country [66] 0 0
Colombia
State/province [66] 0 0
Santander
Country [67] 0 0
Colombia
State/province [67] 0 0
Barranquilla
Country [68] 0 0
Czechia
State/province [68] 0 0
Brno
Country [69] 0 0
Czechia
State/province [69] 0 0
Olomouc
Country [70] 0 0
Czechia
State/province [70] 0 0
Plzen
Country [71] 0 0
Denmark
State/province [71] 0 0
Aarhus N
Country [72] 0 0
Denmark
State/province [72] 0 0
Herning
Country [73] 0 0
Denmark
State/province [73] 0 0
Kobenhavn
Country [74] 0 0
Denmark
State/province [74] 0 0
Sonderborg
Country [75] 0 0
Denmark
State/province [75] 0 0
Vejle
Country [76] 0 0
France
State/province [76] 0 0
Besancon cedex
Country [77] 0 0
France
State/province [77] 0 0
Boulogne-Billancourt
Country [78] 0 0
France
State/province [78] 0 0
Caen
Country [79] 0 0
France
State/province [79] 0 0
Créteil
Country [80] 0 0
France
State/province [80] 0 0
La Roche sur Yon
Country [81] 0 0
France
State/province [81] 0 0
Le Mans
Country [82] 0 0
France
State/province [82] 0 0
Lille Cedex
Country [83] 0 0
France
State/province [83] 0 0
Marseille Cedex 20
Country [84] 0 0
France
State/province [84] 0 0
Montpellier
Country [85] 0 0
France
State/province [85] 0 0
Nantes Cedex 2
Country [86] 0 0
France
State/province [86] 0 0
Nice
Country [87] 0 0
France
State/province [87] 0 0
Nimes cedex 9
Country [88] 0 0
France
State/province [88] 0 0
Paris Cedex 20
Country [89] 0 0
France
State/province [89] 0 0
Paris
Country [90] 0 0
France
State/province [90] 0 0
Pessac Cedex
Country [91] 0 0
France
State/province [91] 0 0
Poitiers CEDEX
Country [92] 0 0
France
State/province [92] 0 0
Quimper
Country [93] 0 0
France
State/province [93] 0 0
Reims Cedex
Country [94] 0 0
France
State/province [94] 0 0
Rennes
Country [95] 0 0
France
State/province [95] 0 0
Rouen Cedex
Country [96] 0 0
France
State/province [96] 0 0
Saint Priest en Jarez
Country [97] 0 0
France
State/province [97] 0 0
Strasbourg Cedex
Country [98] 0 0
France
State/province [98] 0 0
Toulon
Country [99] 0 0
France
State/province [99] 0 0
Toulouse Cedex 9
Country [100] 0 0
France
State/province [100] 0 0
Tours Cedex 9
Country [101] 0 0
France
State/province [101] 0 0
Villefranche Sur Saone Cedex
Country [102] 0 0
France
State/province [102] 0 0
Villejuif
Country [103] 0 0
Germany
State/province [103] 0 0
Chemnitz
Country [104] 0 0
Germany
State/province [104] 0 0
Gauting
Country [105] 0 0
Germany
State/province [105] 0 0
Goettingen
Country [106] 0 0
Germany
State/province [106] 0 0
Kempten
Country [107] 0 0
Germany
State/province [107] 0 0
Muenchen
Country [108] 0 0
Greece
State/province [108] 0 0
Athens
Country [109] 0 0
Greece
State/province [109] 0 0
Marousi
Country [110] 0 0
Greece
State/province [110] 0 0
Thessaloniki
Country [111] 0 0
Hong Kong
State/province [111] 0 0
Hong Kong
Country [112] 0 0
Hong Kong
State/province [112] 0 0
Kowloon
Country [113] 0 0
Hungary
State/province [113] 0 0
Budapest
Country [114] 0 0
Hungary
State/province [114] 0 0
Farkasgyepu
Country [115] 0 0
Hungary
State/province [115] 0 0
Gyongyos
Country [116] 0 0
Hungary
State/province [116] 0 0
Gyor
Country [117] 0 0
Hungary
State/province [117] 0 0
Szekesfehervar
Country [118] 0 0
Hungary
State/province [118] 0 0
Tatabanya
Country [119] 0 0
Hungary
State/province [119] 0 0
Torokbalint
Country [120] 0 0
Italy
State/province [120] 0 0
Bari
Country [121] 0 0
Italy
State/province [121] 0 0
Catania
Country [122] 0 0
Italy
State/province [122] 0 0
Firenze
Country [123] 0 0
Italy
State/province [123] 0 0
Meldola (FC)
Country [124] 0 0
Italy
State/province [124] 0 0
Milano
Country [125] 0 0
Italy
State/province [125] 0 0
Monza (MB)
Country [126] 0 0
Italy
State/province [126] 0 0
Napoli
Country [127] 0 0
Italy
State/province [127] 0 0
Parma
Country [128] 0 0
Italy
State/province [128] 0 0
Perugia
Country [129] 0 0
Japan
State/province [129] 0 0
Aichi
Country [130] 0 0
Japan
State/province [130] 0 0
Aomori
Country [131] 0 0
Japan
State/province [131] 0 0
Chiba
Country [132] 0 0
Japan
State/province [132] 0 0
Ehime
Country [133] 0 0
Japan
State/province [133] 0 0
Fukuoka
Country [134] 0 0
Japan
State/province [134] 0 0
Hiroshima
Country [135] 0 0
Japan
State/province [135] 0 0
Hokkaido
Country [136] 0 0
Japan
State/province [136] 0 0
Hyogo
Country [137] 0 0
Japan
State/province [137] 0 0
Ishikawa
Country [138] 0 0
Japan
State/province [138] 0 0
Kanagawa
Country [139] 0 0
Japan
State/province [139] 0 0
Kyoto
Country [140] 0 0
Japan
State/province [140] 0 0
Miyagi
Country [141] 0 0
Japan
State/province [141] 0 0
Niigata
Country [142] 0 0
Japan
State/province [142] 0 0
Okayama
Country [143] 0 0
Japan
State/province [143] 0 0
Osaka
Country [144] 0 0
Japan
State/province [144] 0 0
Saitama
Country [145] 0 0
Japan
State/province [145] 0 0
Shizuoka
Country [146] 0 0
Japan
State/province [146] 0 0
Tokyo
Country [147] 0 0
Japan
State/province [147] 0 0
Tottori
Country [148] 0 0
Japan
State/province [148] 0 0
Wakayama
Country [149] 0 0
Japan
State/province [149] 0 0
Yamaguchi
Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Goyang-si Gyeonggi-do
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Incheon
Country [152] 0 0
Korea, Republic of
State/province [152] 0 0
Seoul
Country [153] 0 0
Latvia
State/province [153] 0 0
Riga
Country [154] 0 0
Malaysia
State/province [154] 0 0
Pahang
Country [155] 0 0
Malaysia
State/province [155] 0 0
Wilayah Persekutuan
Country [156] 0 0
Mexico
State/province [156] 0 0
Distrito Federal
Country [157] 0 0
Mexico
State/province [157] 0 0
Jalisco
Country [158] 0 0
Mexico
State/province [158] 0 0
Nuevo León
Country [159] 0 0
Mexico
State/province [159] 0 0
Guadalajara
Country [160] 0 0
Netherlands
State/province [160] 0 0
Amersfoort
Country [161] 0 0
Netherlands
State/province [161] 0 0
Groningen
Country [162] 0 0
Netherlands
State/province [162] 0 0
Harderwijk
Country [163] 0 0
Netherlands
State/province [163] 0 0
Maastricht
Country [164] 0 0
Netherlands
State/province [164] 0 0
Tilburg
Country [165] 0 0
Netherlands
State/province [165] 0 0
Zwolle
Country [166] 0 0
Poland
State/province [166] 0 0
Bialystok
Country [167] 0 0
Poland
State/province [167] 0 0
Bystra
Country [168] 0 0
Poland
State/province [168] 0 0
Krakow
Country [169] 0 0
Poland
State/province [169] 0 0
Lodz
Country [170] 0 0
Poland
State/province [170] 0 0
Lublin
Country [171] 0 0
Poland
State/province [171] 0 0
Poznan
Country [172] 0 0
Poland
State/province [172] 0 0
Przemysl
Country [173] 0 0
Poland
State/province [173] 0 0
Warszawa
Country [174] 0 0
Portugal
State/province [174] 0 0
Lisboa
Country [175] 0 0
Portugal
State/province [175] 0 0
Matosinhos
Country [176] 0 0
Portugal
State/province [176] 0 0
Porto
Country [177] 0 0
Romania
State/province [177] 0 0
Bucuresti
Country [178] 0 0
Romania
State/province [178] 0 0
Cluj Napoca
Country [179] 0 0
Romania
State/province [179] 0 0
Craiova
Country [180] 0 0
Romania
State/province [180] 0 0
Iasi
Country [181] 0 0
Romania
State/province [181] 0 0
Ploiesti
Country [182] 0 0
Romania
State/province [182] 0 0
Timisoara
Country [183] 0 0
Singapore
State/province [183] 0 0
Singapore
Country [184] 0 0
Spain
State/province [184] 0 0
Andalucía
Country [185] 0 0
Spain
State/province [185] 0 0
Aragón
Country [186] 0 0
Spain
State/province [186] 0 0
Canarias
Country [187] 0 0
Spain
State/province [187] 0 0
Cantabria
Country [188] 0 0
Spain
State/province [188] 0 0
Cataluña
Country [189] 0 0
Spain
State/province [189] 0 0
Comunidad Valenciana
Country [190] 0 0
Spain
State/province [190] 0 0
Galicia
Country [191] 0 0
Spain
State/province [191] 0 0
Madrid
Country [192] 0 0
Sweden
State/province [192] 0 0
Goteborg
Country [193] 0 0
Sweden
State/province [193] 0 0
Gävle
Country [194] 0 0
Switzerland
State/province [194] 0 0
Aarau
Country [195] 0 0
Switzerland
State/province [195] 0 0
Baden
Country [196] 0 0
Switzerland
State/province [196] 0 0
Basel
Country [197] 0 0
Switzerland
State/province [197] 0 0
Zuerich
Country [198] 0 0
Taiwan
State/province [198] 0 0
Taichung
Country [199] 0 0
Taiwan
State/province [199] 0 0
Tainan
Country [200] 0 0
Taiwan
State/province [200] 0 0
Taipei
Country [201] 0 0
Taiwan
State/province [201] 0 0
Taoyuan
Country [202] 0 0
Thailand
State/province [202] 0 0
Bangkok
Country [203] 0 0
Thailand
State/province [203] 0 0
Chiang Mai
Country [204] 0 0
Thailand
State/province [204] 0 0
Khon Kaen
Country [205] 0 0
Thailand
State/province [205] 0 0
Songkla
Country [206] 0 0
Turkey
State/province [206] 0 0
Adana
Country [207] 0 0
Turkey
State/province [207] 0 0
Ankara
Country [208] 0 0
Turkey
State/province [208] 0 0
Antalya
Country [209] 0 0
Turkey
State/province [209] 0 0
Aydin
Country [210] 0 0
Turkey
State/province [210] 0 0
Denizli
Country [211] 0 0
Turkey
State/province [211] 0 0
Istanbul
Country [212] 0 0
Turkey
State/province [212] 0 0
Izmir
Country [213] 0 0
Turkey
State/province [213] 0 0
Samsun
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Birmingham
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Inverness
Country [216] 0 0
United Kingdom
State/province [216] 0 0
London
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Northwood
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Nottingham
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Sutton
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Torquay
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05920356