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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05920356




Registration number
NCT05920356
Ethics application status
Date submitted
23/05/2023
Date registered
27/06/2023
Date last updated
30/05/2024

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
GenesisCare -North Shore Oncology - St Leonards
Recruitment hospital [4] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 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
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4350 - Toowoomba
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3000 - Melbourne
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Illinois
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United States of America
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Kentucky
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State/province [3] 0 0
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North Carolina
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Pennsylvania
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Tennessee
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Argentina
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Buenos Aires
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Argentina
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Jujuy
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Argentina
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Río Negro
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Santa Fe
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La Rioja
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Salta
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Graz
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Klagenfurt
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Krems
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Salzburg
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Auderghem
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Leuven
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Liège
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Pernambuco
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Ontario
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Quebec
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Chile
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Cautín
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Santiago
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Chile
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Talca
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Guangdong
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Czechia
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Brno
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Olomouc
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Plzen
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Herning
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Sonderborg
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Marseille Cedex 20
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Montpellier
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Nimes cedex 9
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Tours Cedex 9
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Villefranche Sur Saone Cedex
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Villejuif
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Germany
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Chemnitz
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Germany
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Goettingen
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Germany
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Kempten
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Germany
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Muenchen
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Greece
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Athens
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Marousi
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Thessaloniki
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Budapest
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Farkasgyepu
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Torokbalint
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Bari
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Catania
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Firenze
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Italy
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Meldola (FC)
Country [79] 0 0
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Milano
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Italy
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Monza (MB)
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Italy
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Napoli
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Aichi
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Aomori
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Chiba
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Ehime
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Fukuoka
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Hyogo
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Ishikawa
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Kanagawa
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Kyoto
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Miyagi
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Niigata
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Okayama
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Osaka
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Saitama
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Shizuoka
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Tokyo
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Tottori
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Japan
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Wakayama
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Yamaguchi
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Korea, Republic of
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Goyang-si Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Riga
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Malaysia
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Pahang
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Wilayah Persekutuan
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Mexico
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Amersfoort
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Groningen
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Harderwijk
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Tilburg
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Zwolle
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Poland
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Bialystok
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Poland
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Bystra
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Poland
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Krakow
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Lublin
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Poznan
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Przemysl
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Warszawa
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Portugal
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Lisboa
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Portugal
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Matosinhos
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Portugal
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Porto
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Ploiesti
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Romania
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Timisoara
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Singapore
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Singapore
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Spain
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Andalucía
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Canarias
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Cantabria
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Spain
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Cataluña
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Spain
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Comunidad Valenciana
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Spain
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Madrid
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Sweden
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Goteborg
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Sweden
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Gävle
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Switzerland
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Aarau
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Switzerland
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Baden
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Basel
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Taichung
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Tainan
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Taiwan
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Taipei
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Songkla
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Denizli
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Inverness
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Torquay
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United Kingdom
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Truro

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05920356
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05920356