Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-12)
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|ClinicalTrials.gov Identifier: NCT04685135|
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : May 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non Small Cell Lung Cancer Advanced Non Small Cell Lung Cancer||Drug: MRTX849 Drug: Docetaxel||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation|
|Actual Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||July 2024|
21 day cycles
Other Name: adagrasib
|Active Comparator: Docetaxel||
21 day cycles
Other Name: Taxotere
- Progression-free Survival (PFS) [ Time Frame: 30 months ]Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: 30 Months ]Defined as time from date of randomization to date of death due to any cause.
- Adverse Events [ Time Frame: 30 Months ]Defined as number of patients with treatment emergent AEs
- Objective Response Rate (ORR) [ Time Frame: 30 Months ]Defined as the percent of patients documented to have a confirmed CR or PR.
- Duration of Response (DOR) [ Time Frame: 30 Months ]Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
- 1-year Survival Rate [ Time Frame: 30 Months ]
- Plasma PK Parameters of MRTX849 (and metabolites, if applicable) [ Time Frame: 30 Months ]Blood plasma concentrations
- Patient Reported Outcomes (PROs) [ Time Frame: 30 Months ]To be assessed by Lung Cancer Symptom Scale (LCSS).
- Quality of LIfe Assessment [ Time Frame: 30 Months ]To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685135
|Contact: Mirati Therapeutics Study Locator Servicesemail@example.com|
|Study Director:||Julie Meade, MD||Mirati Therapeutics Inc.|