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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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ClinicalTrials.gov Identifier: NCT04685135
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 452 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 : January 29, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: MRTX849 Drug: MRTX849
21 day cycles

Active Comparator: Docetaxel Drug: Docetaxel
21 day cycles
Other Name: Taxotere




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 30 months ]
    Defined as time from date of randomization to date of death due to any cause.

  2. Progression-free Survival (PFS) [ Time Frame: 30 months ]
    Defined as time from randomization until disease progression or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 Months ]
    Defined as number of patients with treatment emergent AEs

  2. Objective Response Rate (ORR) [ Time Frame: 30 Months ]
    Defined as the percent of patients documented to have a confirmed CR or PR.

  3. 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.

  4. Patient Reported Outcomes (PROs) [ Time Frame: 30 Months ]
    To be assessed by Lung Cancer Symptom Scale (LCSS).

  5. Quality of LIfe Assessment [ Time Frame: 30 Months ]
    To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).



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.

Exclusion Criteria:

  • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510).
  • Active brain metastases.

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@emergingmed.com

Locations
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United States, California
Research Site Recruiting
Whittier, California, United States, 90603
United States, Colorado
Research Site Recruiting
Lone Tree, Colorado, United States, 80124
United States, Florida
Research Site Recruiting
Jacksonville, Florida, United States, 32204
Research Site Recruiting
Pensacola, Florida, United States, 32503
United States, Georgia
Research Site Recruiting
Athens, Georgia, United States, 30607
United States, Illinois
Research Site Recruiting
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Research Site Recruiting
Goshen, Indiana, United States, 46526
United States, Kansas
Research Site Recruiting
Wichita, Kansas, United States, 67214
United States, Maine
Research Site Recruiting
Scarborough, Maine, United States, 04074
United States, Missouri
Research Site Recruiting
Bolivar, Missouri, United States, 65613
United States, Ohio
Research Site Recruiting
Kettering, Ohio, United States, 45429
United States, Oregon
Research Site Recruiting
Salem, Oregon, United States, 97301
United States, South Carolina
Research Site Recruiting
Easley, South Carolina, United States, 29640
United States, Texas
Research Site Recruiting
Arlington, Texas, United States, 76012
Research Site Recruiting
Austin, Texas, United States, 78731
Research Site Recruiting
Sherman, Texas, United States, 75090
United States, Virginia
Research Site Recruiting
Arlington, Virginia, United States, 22205
Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Bill Paxton, MD PhD Mirati Therapeutics Inc.
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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: April 29, 2021
Last Verified: April 2021
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
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
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action