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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)

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ClinicalTrials.gov Identifier: NCT04685135
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE December 21, 2020
First Posted Date  ICMJE December 28, 2020
Last Update Posted Date January 4, 2023
Actual Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2021)
Progression-free Survival (PFS) [ Time Frame: 30 months ]
Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
  • Overall Survival (OS) [ Time Frame: 30 months ]
    Defined as time from date of randomization to date of death due to any cause.
  • Progression-free Survival (PFS) [ Time Frame: 30 months ]
    Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2022)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
  • 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.
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Official Title  ICMJE A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Non Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: MRTX849
    21 day cycles
    Other Name: adagrasib
  • Drug: Docetaxel
    21 day cycles
    Other Name: Taxotere
Study Arms  ICMJE
  • Experimental: MRTX849
    Intervention: Drug: MRTX849
  • Active Comparator: Docetaxel
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2021)
340
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2020)
452
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@emergingmed.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Czechia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT04685135
Other Study ID Numbers  ICMJE 849-012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mirati Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mirati Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Julie Meade, MD Mirati Therapeutics Inc.
PRS Account Mirati Therapeutics Inc.
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP