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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
Date last updated
25/03/2025
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]
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CA239-0013
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Secondary ID [2]
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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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Advanced Non Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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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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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) as Per Blinded Independent Central Review
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Assessment method [1]
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Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
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Timepoint [1]
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From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
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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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Overall survival is defined as the time from randomization to the date of death due to any cause.
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Timepoint [1]
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From randomization till death due to any cause (up to approximately 143 weeks)
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Secondary outcome [2]
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Objective Response Rate (ORR) as Per Blinded Independent Central Review
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Assessment method [2]
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Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
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Timepoint [2]
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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)
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Secondary outcome [3]
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Duration of Response (DOR) as Per Blinded Independent Central Review
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Assessment method [3]
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Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
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Timepoint [3]
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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)
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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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Timepoint [4]
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Up to 49 months
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Secondary outcome [5]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [5]
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Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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Timepoint [5]
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From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
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Secondary outcome [6]
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Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters
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Assessment method [6]
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Blood samples were collected to assess hematology parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
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Timepoint [6]
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From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
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Secondary outcome [7]
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Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters
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Assessment method [7]
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Blood samples were collected to assess chemistry parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
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Timepoint [7]
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From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
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Secondary outcome [8]
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Plasma Concentration of Adagrasib
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Assessment method [8]
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Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms.
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Timepoint [8]
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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)
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Secondary outcome [9]
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Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score
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Assessment method [9]
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The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Least Square Mean and Confidence Interval are from a repeated measures model on the response variable change from baseline in LCSS average total score.
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Timepoint [9]
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Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
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Secondary outcome [10]
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Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score
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Assessment method [10]
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The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score.
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Timepoint [10]
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Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
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Secondary outcome [11]
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Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score
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Assessment method [11]
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The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score.
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Timepoint [11]
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Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
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Secondary outcome [12]
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Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score
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Assessment method [12]
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The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points.
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Timepoint [12]
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Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
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Secondary outcome [13]
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Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score
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Assessment method [13]
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The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index.
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Timepoint [13]
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Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
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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
23/02/2021
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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
2/07/2026
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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)
QLD
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Recruitment hospital [1]
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Local Institution - 012-016 - Mackay
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Recruitment hospital [2]
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Local Institution - 012-005 - Bedford Park
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Local Institution - 012-004 - Clayton
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Recruitment hospital [4]
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Townsville University Hospital - Douglas
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Local Institution - 012-013 - St. Leonards
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Recruitment hospital [6]
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Local Institution - 012-019 - Tweed Heads
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Recruitment hospital [7]
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Cancer Care Wollongong - Wollongong
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Recruitment hospital [8]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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4740 - Mackay
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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4814 - Douglas
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Recruitment postcode(s) [5]
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2065 - St. Leonards
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Recruitment postcode(s) [6]
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2485 - Tweed Heads
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Recruitment postcode(s) [7]
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2500 - Wollongong
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Recruitment postcode(s) [8]
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4102 - Woolloongabba
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Recruitment outside Australia
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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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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/35/NCT04685135/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/35/NCT04685135/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04685135
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