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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04303780




Registration number
NCT04303780
Ethics application status
Date submitted
5/03/2020
Date registered
11/03/2020
Date last updated
30/11/2020

Titles & IDs
Public title
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
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
Secondary ID [1] 0 0
2019-003582-18
Secondary ID [2] 0 0
20190009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
KRAS p, G12c Mutated /Advanced Metastatic NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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

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

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) - Defined as time from randomization until disease progression or death from any cause, whichever occurs first
Timepoint [1] 0 0
Baseline to approximately 6 years
Secondary outcome [1] 0 0
Overall Survival (OS) - Defined as time from randomization to death by any cause
Timepoint [1] 0 0
Baseline to approximately 6 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR) - Defined as complete response (CR ) + partial response (PR)
Timepoint [2] 0 0
Baseline to approximately 6 years
Secondary outcome [3] 0 0
Patient Reported Outcomes (PRO) - To be assessed by Patient-reported symptoms from selected PRO-Common Terminology Criteria for Adverse Events questions and GP5 of Functional Assessment of Cancer Therapy Tool General form (FACT-G)
Timepoint [3] 0 0
Baseline to week 12
Secondary outcome [4] 0 0
Quality of Life Assessment - To be as assessed by: European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 13 (EORTC QLQ-LC13) and European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30)
Timepoint [4] 0 0
Baseline to week 12
Secondary outcome [5] 0 0
Duration of response (DOR) - Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first.
Timepoint [5] 0 0
Baseline to approximately 6 years
Secondary outcome [6] 0 0
Time to response (TTR) - Defined as time from randomization to first evidence of PR or CR
Timepoint [6] 0 0
Baseline to approximately 6 years
Secondary outcome [7] 0 0
Disease control rate (DCR) - Defined as rate of confirmed objective response (CR or PR) + stable disease (SD) of at least 6 weeks
Timepoint [7] 0 0
Baseline to approximately 6 years
Secondary outcome [8] 0 0
Number of subjects with Clinically significant changes in vital signs
Timepoint [8] 0 0
Approximately 1 year
Secondary outcome [9] 0 0
Number of subjects with treatment-emergent adverse events
Timepoint [9] 0 0
Estimated up to approximately 6 years
Secondary outcome [10] 0 0
Number of subjects with Clinically significant changes in Laboratory tests
Timepoint [10] 0 0
Estimated up to approximately 1 year
Secondary outcome [11] 0 0
Number of Subjects with treatment-related adverse events
Timepoint [11] 0 0
Estimated up to 6 years
Secondary outcome [12] 0 0
Maximum plasma concentration (Cmax) - To characterize the pharmacokinetics (PK) of AMG 510
Timepoint [12] 0 0
Estimated up to 4 months
Secondary outcome [13] 0 0
Area under the plasma concentration-time curve (AUC) - To characterize the pharmacokinetics (PK) of AMG 510
Timepoint [13] 0 0
Estimated up to 4 months

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 molecular testing
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MelbourneNSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Blacktown
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Kogarah
Recruitment hospital [5] 0 0
Research Site - Liverpool
Recruitment hospital [6] 0 0
Research Site - Chermside
Recruitment hospital [7] 0 0
Research Site - Woolloongabba
Recruitment hospital [8] 0 0
Research Site - Woodville South
Recruitment hospital [9] 0 0
Research Site - Subiaco
Recruitment hospital [10] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5011 - Woodville South
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment outside Australia
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California
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Colorado
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT04303780
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/show/NCT04303780