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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/NCT04685135




Registration number
NCT04685135
Ethics application status
Date submitted
21/12/2020
Date registered
28/12/2020
Date last updated
28/03/2024

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
849-012
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
1/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
453
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Douglas
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Mackay
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Research Site - Saint Leonards
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Research Site - Tweed Heads
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Research Site - Wollongong
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Research Site - Woolloongabba
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- Bedford Park
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- Douglas
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- Heidelberg
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- Mackay
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- Saint Leonards
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- Tweed Heads
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- Wollongong
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- Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mirati Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04685135
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julie Meade, MD
Address 0 0
Mirati Therapeutics Inc.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04685135