Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-12)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04685135|
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : May 19, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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 has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 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 :||May 2025|
|Estimated Study Completion Date :||November 2025|
21 day cycles
|Active Comparator: Docetaxel||
21 day cycles
Other Name: Taxotere
- Progression-free Survival (PFS) [ Time Frame: 32 Months ]Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: 49 Months ]Defined as time from date of randomization to date of death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: 32 Months ]Defined as the percent of patients documented to have a confirmed CR or PR.
- Duration of Response (DOR) [ Time Frame: 49 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: 49 Months ]
- Safety [ Time Frame: 49 Months ]characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event.
- Population PK parameters of MRTX849 [ Time Frame: 49 Months ]Data for this Outcome Measure will not be reported here but will be used in a Population PK Analysis which will include participants who were not enrolled in this study, and issued in a separate report. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules
- Patient Reported Outcomes (PROs) [ Time Frame: 49 Months ]To be assessed by Lung Cancer Symptom Scale (LCSS).
- Quality of LIfe Assessment [ Time Frame: 49 Months ]To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
- Candidacy to receive treatment with docetaxel.
Crossover Inclusion Criteria:
- Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
- ECOG performance status 0-2
- Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
- Active brain metastases.
Crossover Exclusion Criteria:
- Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
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 Servicesfirstname.lastname@example.org|
|Study Director:||Julie Meade, MD||Mirati Therapeutics Inc.|
|Responsible Party:||Mirati Therapeutics Inc.|
|Other Study ID Numbers:||
|First Posted:||December 28, 2020 Key Record Dates|
|Last Update Posted:||May 19, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Non-small cell lung cancer
Phase 3 Clinical Trial
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action