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Trial record 1 of 1 for:    849-012
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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 : June 7, 2023
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Study Description
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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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: MRTX849 Drug: MRTX849
21 day cycles
Other Names:
  • adagrasib
  • KRAZATI
Active Comparator: Docetaxel Drug: Docetaxel
21 day cycles
Other Name: Taxotere


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 32 Months ]
    Defined as time from randomization until disease progression or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 49 Months ]
    Defined as time from date of randomization to date of death due to any cause.

  2. Objective Response Rate (ORR) [ Time Frame: 32 Months ]
    Defined as the percent of patients documented to have a confirmed CR or PR.

  3. 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.

  4. 1-year Survival Rate [ Time Frame: 49 Months ]
  5. 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.

  6. 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

  7. Patient Reported Outcomes (PROs) [ Time Frame: 49 Months ]
    To be assessed by Lung Cancer Symptom Scale (LCSS).

  8. Quality of LIfe Assessment [ Time Frame: 49 Months ]
    To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@careboxhealth.com

Locations
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Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Julie Meade, MD Mirati Therapeutics Inc.
More Information
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04685135    
Other Study ID Numbers: 849-012
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mirati Therapeutics Inc.:
KRAS G12C
Non-small cell lung cancer
NSCLC
Metastatic Cancer
Docetaxel
 Phase 3 Clinical Trial
Adagrasib
KRAS
KRAZATI
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Docetaxel
Adagrasib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action