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/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)
Query!
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)
Query!
Secondary ID [1]
0
0
2022-501863-41
Query!
Secondary ID [2]
0
0
20190341
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC)
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
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
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 is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
Query!
Timepoint [1]
0
0
From Baseline up to end of study (EOS) (approximately 5.5 years)
Query!
Secondary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.
Query!
Timepoint [1]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [2]
0
0
Overall Survival (OS)
Query!
Assessment method [2]
0
0
OS is defined as the time from randomization until death due to any cause.
Query!
Timepoint [2]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [3]
0
0
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
From Baseline to Week 12
Query!
Secondary outcome [4]
0
0
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
From Baseline to Week 12
Query!
Secondary outcome [5]
0
0
Change in QLQ-LC13 Symptoms of Cough Subscale
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
From Baseline to Week 12
Query!
Secondary outcome [6]
0
0
Change in QLQ-LC13 Symptoms of Chest Pain Subscale
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
From Baseline to Week 12
Query!
Secondary outcome [7]
0
0
Change in Physical Function as Measured by QLQ-C30
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
From Baseline to Week 12
Query!
Secondary outcome [8]
0
0
Change in Global Health Status as Measured by QLQ-C30
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
From Baseline to Week 12
Query!
Secondary outcome [9]
0
0
Progression-free Survival 2 (PFS2)
Query!
Assessment method [9]
0
0
PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or treatment beyond progression (ie, second progression) or death from any cause, whichever occurs first.
Query!
Timepoint [9]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [10]
0
0
Change in QLQ-LC13 Subscale Scores
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [11]
0
0
Change in QLQ-C30 Subscale Scores
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [12]
0
0
Time to Deterioration in QLC-LC13 Subscale Scores
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
From Baseline to Week 12
Query!
Secondary outcome [13]
0
0
Time to Deterioration in QLC-C30 Subscale Scores
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
From Baseline to Week 12
Query!
Secondary outcome [14]
0
0
Change in Summary Scores and Visual Analogue Scale (VAS) Scores
Query!
Assessment method [14]
0
0
Measured by EuroQol-5 Dimension (EQ-5D-5L).
Query!
Timepoint [14]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [15]
0
0
Duration of Response
Query!
Assessment method [15]
0
0
Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.
Query!
Timepoint [15]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [16]
0
0
Time to Response
Query!
Assessment method [16]
0
0
Defined as the time from randomization to first evidence of PR or CR per BICR.
Query!
Timepoint [16]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [17]
0
0
Disease Control
Query!
Assessment method [17]
0
0
Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.
Query!
Timepoint [17]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [18]
0
0
PFS
Query!
Assessment method [18]
0
0
Based on investigator tumor assessments per RECIST v1.1.
Query!
Timepoint [18]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [19]
0
0
Objective Response
Query!
Assessment method [19]
0
0
Based on investigator tumor assessments per RECIST v1.1.
Query!
Timepoint [19]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [20]
0
0
Number of Participants With Treatment-Emergent Adverse Events
Query!
Assessment method [20]
0
0
Query!
Timepoint [20]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [21]
0
0
Number of Participants With Clinically Significant Changes in Vital Signs
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [22]
0
0
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
From Baseline up to EOS (approximately 5.5 years)
Query!
Secondary outcome [23]
0
0
Maximum Plasma Concentration (Cmax) of Sotorasib
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Pre-dose Day 1 up to Day 64
Query!
Secondary outcome [24]
0
0
Minimum Plasma Concentration (Cmin) of Sotorasib
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
Pre-dose Day 1 up to Day 64
Query!
Secondary outcome [25]
0
0
Area Under The Curve (AUC) of Sotorasib
Query!
Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
Pre-dose Day 1 up to Day 64
Query!
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
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
* 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
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
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/11/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/03/2031
Query!
Actual
Query!
Sample size
Target
750
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Campbelltown Hospital - Campbelltown
Query!
Recruitment hospital [2]
0
0
Concord Repatriation General Hospital - Concord
Query!
Recruitment hospital [3]
0
0
GenesisCare -North Shore Oncology - St Leonards
Query!
Recruitment hospital [4]
0
0
Calvary Mater Newcastle Hospital - Waratah
Query!
Recruitment hospital [5]
0
0
Toowoomba Hospital - Toowoomba
Query!
Recruitment hospital [6]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [7]
0
0
Cancer Research South Australia - Adelaide
Query!
Recruitment hospital [8]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [9]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [2]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [3]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [4]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [5]
0
0
4350 - Toowoomba
Query!
Recruitment postcode(s) [6]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [7]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [8]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [9]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Illinois
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Kentucky
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
New Mexico
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
North Carolina
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Pennsylvania
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Tennessee
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Buenos Aires
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Jujuy
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Río Negro
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Santa Fe
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
La Rioja
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Salta
Query!
Country [14]
0
0
Austria
Query!
State/province [14]
0
0
Graz
Query!
Country [15]
0
0
Austria
Query!
State/province [15]
0
0
Klagenfurt
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Krems
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Salzburg
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Auderghem
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Gent
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Leuven
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Liège
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Mechelen
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Distrito Federal
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Pará
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Pernambuco
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Rio Grande Do Sul
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Santa Catarina
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
São Paulo
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Rio de Janeiro
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Panagyurishte
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Sofia
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Nova Scotia
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Ontario
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Quebec
Query!
Country [35]
0
0
Chile
Query!
State/province [35]
0
0
Cautín
Query!
Country [36]
0
0
Chile
Query!
State/province [36]
0
0
Santiago
Query!
Country [37]
0
0
Chile
Query!
State/province [37]
0
0
Talca
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Guangdong
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Guangxi
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Henan
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Hubei
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Hunan
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Jiangsu
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Jiangxi
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Shandong
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Sichuan
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Zhejiang
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Beijing
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Cesar
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Brno
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Olomouc
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Plzen
Query!
Country [53]
0
0
Denmark
Query!
State/province [53]
0
0
Aarhus N
Query!
Country [54]
0
0
Denmark
Query!
State/province [54]
0
0
Herning
Query!
Country [55]
0
0
Denmark
Query!
State/province [55]
0
0
Kobenhavn
Query!
Country [56]
0
0
Denmark
Query!
State/province [56]
0
0
Sonderborg
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Besancon cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Boulogne-Billancourt
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Créteil
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Le Mans
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Lille Cedex
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Marseille Cedex 20
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Montpellier
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Nimes cedex 9
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Paris Cedex 20
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Paris
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Pessac Cedex
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Poitiers Cedex
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Quimper
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Reims Cedex
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Rennes
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Rouen Cedex
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Strasbourg Cedex
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Toulon
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Toulouse Cedex 9
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Tours Cedex 9
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Villefranche Sur Saone Cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Villejuif
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Chemnitz
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Goettingen
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Kempten
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Muenchen
Query!
Country [83]
0
0
Greece
Query!
State/province [83]
0
0
Athens
Query!
Country [84]
0
0
Greece
Query!
State/province [84]
0
0
Marousi
Query!
Country [85]
0
0
Greece
Query!
State/province [85]
0
0
Thessaloniki
Query!
Country [86]
0
0
Hong Kong
Query!
State/province [86]
0
0
Hong Kong
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Budapest
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Farkasgyepu
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Gyongyos
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Szekesfehervar
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Tatabanya
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Torokbalint
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Bari
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
Meldola (FC)
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Milano
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
Parma
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Perugia
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Aichi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Aomori
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Chiba
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Ehime
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Fukuoka
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Hiroshima
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Hokkaido
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Hyogo
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Ishikawa
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Kanagawa
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Kyoto
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Miyagi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Niigata
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Okayama
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Osaka
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Saitama
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Shizuoka
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Tokyo
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Tottori
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Wakayama
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Yamaguchi
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Goyang-si Gyeonggi-do
Query!
Country [124]
0
0
Korea, Republic of
Query!
State/province [124]
0
0
Incheon
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Seoul
Query!
Country [126]
0
0
Latvia
Query!
State/province [126]
0
0
Riga
Query!
Country [127]
0
0
Malaysia
Query!
State/province [127]
0
0
Pahang
Query!
Country [128]
0
0
Malaysia
Query!
State/province [128]
0
0
Wilayah Persekutuan
Query!
Country [129]
0
0
Mexico
Query!
State/province [129]
0
0
Distrito Federal
Query!
Country [130]
0
0
Mexico
Query!
State/province [130]
0
0
Jalisco
Query!
Country [131]
0
0
Mexico
Query!
State/province [131]
0
0
Nuevo León
Query!
Country [132]
0
0
Mexico
Query!
State/province [132]
0
0
Guadalajara
Query!
Country [133]
0
0
Netherlands
Query!
State/province [133]
0
0
Amersfoort
Query!
Country [134]
0
0
Netherlands
Query!
State/province [134]
0
0
Groningen
Query!
Country [135]
0
0
Netherlands
Query!
State/province [135]
0
0
Harderwijk
Query!
Country [136]
0
0
Netherlands
Query!
State/province [136]
0
0
Maastricht
Query!
Country [137]
0
0
Netherlands
Query!
State/province [137]
0
0
Tilburg
Query!
Country [138]
0
0
Netherlands
Query!
State/province [138]
0
0
Zwolle
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Bialystok
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Bystra
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Krakow
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Lublin
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Poznan
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Przemysl
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Warszawa
Query!
Country [146]
0
0
Portugal
Query!
State/province [146]
0
0
Lisboa
Query!
Country [147]
0
0
Portugal
Query!
State/province [147]
0
0
Matosinhos
Query!
Country [148]
0
0
Portugal
Query!
State/province [148]
0
0
Porto
Query!
Country [149]
0
0
Romania
Query!
State/province [149]
0
0
Bucuresti
Query!
Country [150]
0
0
Romania
Query!
State/province [150]
0
0
Cluj Napoca
Query!
Country [151]
0
0
Romania
Query!
State/province [151]
0
0
Craiova
Query!
Country [152]
0
0
Romania
Query!
State/province [152]
0
0
Iasi
Query!
Country [153]
0
0
Romania
Query!
State/province [153]
0
0
Ploiesti
Query!
Country [154]
0
0
Romania
Query!
State/province [154]
0
0
Timisoara
Query!
Country [155]
0
0
Singapore
Query!
State/province [155]
0
0
Singapore
Query!
Country [156]
0
0
Spain
Query!
State/province [156]
0
0
Andalucía
Query!
Country [157]
0
0
Spain
Query!
State/province [157]
0
0
Aragón
Query!
Country [158]
0
0
Spain
Query!
State/province [158]
0
0
Canarias
Query!
Country [159]
0
0
Spain
Query!
State/province [159]
0
0
Cantabria
Query!
Country [160]
0
0
Spain
Query!
State/province [160]
0
0
Cataluña
Query!
Country [161]
0
0
Spain
Query!
State/province [161]
0
0
Comunidad Valenciana
Query!
Country [162]
0
0
Spain
Query!
State/province [162]
0
0
Madrid
Query!
Country [163]
0
0
Sweden
Query!
State/province [163]
0
0
Goteborg
Query!
Country [164]
0
0
Sweden
Query!
State/province [164]
0
0
Gävle
Query!
Country [165]
0
0
Switzerland
Query!
State/province [165]
0
0
Aarau
Query!
Country [166]
0
0
Switzerland
Query!
State/province [166]
0
0
Baden
Query!
Country [167]
0
0
Switzerland
Query!
State/province [167]
0
0
Basel
Query!
Country [168]
0
0
Taiwan
Query!
State/province [168]
0
0
Taichung
Query!
Country [169]
0
0
Taiwan
Query!
State/province [169]
0
0
Tainan
Query!
Country [170]
0
0
Taiwan
Query!
State/province [170]
0
0
Taipei
Query!
Country [171]
0
0
Taiwan
Query!
State/province [171]
0
0
Taoyuan
Query!
Country [172]
0
0
Thailand
Query!
State/province [172]
0
0
Bangkok
Query!
Country [173]
0
0
Thailand
Query!
State/province [173]
0
0
Chiang Mai
Query!
Country [174]
0
0
Thailand
Query!
State/province [174]
0
0
Khon Kaen
Query!
Country [175]
0
0
Thailand
Query!
State/province [175]
0
0
Songkla
Query!
Country [176]
0
0
Turkey
Query!
State/province [176]
0
0
Adana
Query!
Country [177]
0
0
Turkey
Query!
State/province [177]
0
0
Ankara
Query!
Country [178]
0
0
Turkey
Query!
State/province [178]
0
0
Antalya
Query!
Country [179]
0
0
Turkey
Query!
State/province [179]
0
0
Denizli
Query!
Country [180]
0
0
Turkey
Query!
State/province [180]
0
0
Istanbul
Query!
Country [181]
0
0
Turkey
Query!
State/province [181]
0
0
Izmir
Query!
Country [182]
0
0
United Kingdom
Query!
State/province [182]
0
0
Birmingham
Query!
Country [183]
0
0
United Kingdom
Query!
State/province [183]
0
0
Inverness
Query!
Country [184]
0
0
United Kingdom
Query!
State/province [184]
0
0
Nottingham
Query!
Country [185]
0
0
United Kingdom
Query!
State/province [185]
0
0
Torquay
Query!
Country [186]
0
0
United Kingdom
Query!
State/province [186]
0
0
Truro
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
The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05920356
Query!
Trial related presentations / publications
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
Amgen Call Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
866-572-6436
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
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: http://www.amgen.com/datasharing
Query!
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