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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) as Per Blinded Independent Central Review
Timepoint [1] 0 0
From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization till death due to any cause (up to approximately 143 weeks)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) as Per Blinded Independent Central Review
Timepoint [2] 0 0
From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)
Secondary outcome [3] 0 0
Duration of Response (DOR) as Per Blinded Independent Central Review
Timepoint [3] 0 0
First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)
Secondary outcome [4] 0 0
1-Year Survival Rate
Timepoint [4] 0 0
Up to 49 months
Secondary outcome [5] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Secondary outcome [6] 0 0
Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters
Timepoint [6] 0 0
From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Secondary outcome [7] 0 0
Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters
Timepoint [7] 0 0
From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
Secondary outcome [8] 0 0
Plasma Concentration of Adagrasib
Timepoint [8] 0 0
Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)
Secondary outcome [9] 0 0
Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score
Timepoint [9] 0 0
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Secondary outcome [10] 0 0
Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score
Timepoint [10] 0 0
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Secondary outcome [11] 0 0
Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score
Timepoint [11] 0 0
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Secondary outcome [12] 0 0
Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score
Timepoint [12] 0 0
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Secondary outcome [13] 0 0
Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score
Timepoint [13] 0 0
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

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
23/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/07/2026
Actual
Sample size
Target
Accrual to date
Final
453
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Local Institution - 012-016 - Mackay
Recruitment hospital [2] 0 0
Local Institution - 012-005 - Bedford Park
Recruitment hospital [3] 0 0
Local Institution - 012-004 - Clayton
Recruitment hospital [4] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [5] 0 0
Local Institution - 012-013 - St. Leonards
Recruitment hospital [6] 0 0
Local Institution - 012-019 - Tweed Heads
Recruitment hospital [7] 0 0
Cancer Care Wollongong - Wollongong
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4740 - Mackay
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
2065 - St. Leonards
Recruitment postcode(s) [6] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Thun
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Winterthur
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Birmingham
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Edinburgh
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Leicester
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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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04685135