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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04685135
Registration number
NCT04685135
Ethics application status
Date submitted
21/12/2020
Date registered
28/12/2020
Titles & IDs
Public title
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
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Scientific title
A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
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Secondary ID [1]
0
0
CA239-0013
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Secondary ID [2]
0
0
CA239-0013
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Universal Trial Number (UTN)
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Trial acronym
KRYSTAL-12
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Non Small Cell Lung Cancer
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0
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Advanced Non Small Cell Lung Cancer
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0
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Condition category
Condition code
Cancer
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0
0
0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
0
0
0
0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - MRTX849
Treatment: Drugs - Docetaxel
Experimental: MRTX849 -
Active comparator: Docetaxel -
Treatment: Drugs: MRTX849
21 day cycles
Treatment: Drugs: Docetaxel
21 day cycles
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
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Timepoint [1]
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32 Months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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0
Defined as time from date of randomization to date of death due to any cause.
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Timepoint [1]
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49 Months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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0
Defined as the percent of patients documented to have a confirmed CR or PR.
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Timepoint [2]
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32 Months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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0
Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
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Timepoint [3]
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49 Months
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Secondary outcome [4]
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1-year Survival Rate
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Assessment method [4]
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0
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Timepoint [4]
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49 Months
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Secondary outcome [5]
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Safety
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Assessment method [5]
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characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event.
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Timepoint [5]
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49 Months
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Secondary outcome [6]
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Population PK parameters of MRTX849
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Assessment method [6]
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Data for this Outcome Measure will not be reported here but will be used in a Population PK Analysis which will include participants who were not enrolled in this study, and issued in a separate report. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules
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Timepoint [6]
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49 Months
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Secondary outcome [7]
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Patient Reported Outcomes (PROs)
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Assessment method [7]
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To be assessed by Lung Cancer Symptom Scale (LCSS).
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Timepoint [7]
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49 Months
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Secondary outcome [8]
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Quality of LIfe Assessment
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Assessment method [8]
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To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
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Timepoint [8]
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49 Months
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
* Candidacy to receive treatment with docetaxel.
Crossover
* Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
* ECOG performance status 0-2
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
* Active brain metastases.
Crossover
* Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
453
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [2]
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Monash Health - Clayton
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Townsville University Hospital - Douglas
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GenesisCare - North Shore - St. Leonards
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The Tweed Hospital - Tweed Heads
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Cancer Care Wollongong - Wollongong
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Recruitment hospital [7]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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3168 - Clayton
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4814 - Douglas
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2065 - St. Leonards
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2485 - Tweed Heads
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2500 - Wollongong
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Recruitment postcode(s) [7]
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4102 - Woolloongabba
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Recruitment outside Australia
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Porto
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Chelyabinsk
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Novosibirsk
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Omsk
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A Coruna
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Alicante
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Badalona
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Cordoba
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Girona
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Leon
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Madrid
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Malaga
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Valencia
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Basel
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Winterthur
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Birmingham
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Leicester
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Mirati Therapeutics Inc.
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Address
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Ethics approval
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Summary
Brief summary
This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.
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Trial website
https://clinicaltrials.gov/study/NCT04685135
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT04685135