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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 July 2021 |
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Main ID: |
NCT04685135 |
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Date of registration:
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21/12/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
KRYSTAL-12 |
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Scientific title:
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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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Date of first enrolment:
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January 29, 2021 |
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Target sample size:
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452 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04685135 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Puerto Rico
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United States
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Contacts
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Name:
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Mirati Therapeutics Study Locator Services |
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Address:
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Telephone:
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1-844-893-5530 |
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Email:
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miratistudylocator@emergingmed.com |
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Affiliation:
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Name:
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Bill Paxton, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mirati Therapeutics Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
- Candidacy to receive treatment with docetaxel.
Exclusion Criteria:
- Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510).
- Active brain metastases.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Advanced Non Small Cell Lung Cancer
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Metastatic Non Small Cell Lung Cancer
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Intervention(s)
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Drug: Docetaxel
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Drug: MRTX849
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Primary Outcome(s)
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Overall Survival (OS)
[Time Frame: 30 months]
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Progression-free Survival (PFS)
[Time Frame: 30 months]
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Secondary Outcome(s)
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Adverse Events
[Time Frame: 30 Months]
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Duration of Response (DOR)
[Time Frame: 30 Months]
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Objective Response Rate (ORR)
[Time Frame: 30 Months]
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Patient Reported Outcomes (PROs)
[Time Frame: 30 Months]
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Quality of LIfe Assessment
[Time Frame: 30 Months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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