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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
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
Secondary ID [1] 0 0
CA239-0013
Secondary ID [2] 0 0
CA239-0013
Universal Trial Number (UTN)
Trial acronym
KRYSTAL-12
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Non Small Cell Lung Cancer 0 0
Advanced Non Small Cell Lung Cancer 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(has expanded access)
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

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
32 Months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
49 Months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
32 Months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
49 Months
Secondary outcome [4] 0 0
1-year Survival Rate
Timepoint [4] 0 0
49 Months
Secondary outcome [5] 0 0
Safety
Timepoint [5] 0 0
49 Months
Secondary outcome [6] 0 0
Population PK parameters of MRTX849
Timepoint [6] 0 0
49 Months
Secondary outcome [7] 0 0
Patient Reported Outcomes (PROs)
Timepoint [7] 0 0
49 Months
Secondary outcome [8] 0 0
Quality of LIfe Assessment
Timepoint [8] 0 0
49 Months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Active, not 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)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [4] 0 0
GenesisCare - North Shore - St. Leonards
Recruitment hospital [5] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [6] 0 0
Cancer Care Wollongong - Wollongong
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Missouri
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Montana
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New Jersey
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New York
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Ohio
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Oregon
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Rhode Island
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South Carolina
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South Dakota
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Texas
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Utah
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Virginia
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Austria
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Klagenfurt Am Woerthersee
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Salzburg
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Wien
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Brussel
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Hasselt
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France
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Gleize
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Gauting
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Halle
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Germany
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Germany
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Koln
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Germany
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Lubeck
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Greece
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Central
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Hungary
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Budapest
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Hungary
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Gyongyos
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Hungary
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Gyula
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Hungary
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Szekesfehervar
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Hungary
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Torokbalint
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Limerick
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Avellino
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Aviano
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Bari
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Brescia
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Candiolo
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Catania
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Leon
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Lugo
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Madrid
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Majadahonda
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Malaga
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Santander
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mirati Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.