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KRYSTAL-12: Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Sponsor
Mirati Therapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04685135
Collaborator
(none)
340
Enrollment
142
Locations
2
Arms
39
Anticipated Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
340 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 :
Apr 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: MRTX849

Drug: MRTX849
21 day cycles
Other Names:
  • adagrasib

    		•
    Active Comparator: Docetaxel

    Drug: Docetaxel
    21 day cycles
    Other Names:
  • Taxotere

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) [30 months]

      Defined as time from randomization until disease progression or death from any cause, whichever occurs first.

    Secondary Outcome Measures

    1. Overall Survival (OS) [30 Months]

      Defined as time from date of randomization to date of death due to any cause.

    2. Adverse Events [30 Months]

      Defined as number of patients with treatment emergent AEs

    3. Objective Response Rate (ORR) [30 Months]

      Defined as the percent of patients documented to have a confirmed CR or PR.

    4. Duration of Response (DOR) [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.

    5. 1-year Survival Rate [30 Months]

    6. Plasma PK Parameters of MRTX849 (and metabolites, if applicable) [30 Months]

      Blood plasma concentrations

    7. Patient Reported Outcomes (PROs) [30 Months]

      To be assessed by Lung Cancer Symptom Scale (LCSS).

    8. Quality of LIfe Assessment [30 Months]

      To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Santa Rosa California United States 95403
    2 Research Site Whittier California United States 90603
    3 Research Site Grand Junction Colorado United States 81502
    4 Research Site Lafayette Colorado United States 80026
    5 Research Site Lone Tree Colorado United States 80124
    6 Research Site Fort Lauderdale Florida United States 33308
    7 Research Site Jacksonville Florida United States 32204
    8 Research Site Jacksonville Florida United States 32256
    9 Research Site Miami Beach Florida United States 33140
    10 Research Site Orlando Florida United States 32806
    11 Research Site Plantation Florida United States 33322
    12 Research Site Athens Georgia United States 30607
    13 Research Site Marietta Georgia United States 30060
    14 Research Site Chicago Illinois United States 60612
    15 Research Site Chicago Illinois United States 60637
    16 Research Site Goshen Indiana United States 46526
    17 Research Site Indianapolis Indiana United States 46237
    18 Research Site Westwood Kansas United States 66205
    19 Research Site Wichita Kansas United States 67214
    20 Research Site New Orleans Louisiana United States 70112
    21 Research Site Scarborough Maine United States 04074
    22 Research Site Frederick Maryland United States 21702
    23 Research Site Billings Montana United States 59102
    24 Research Site East Brunswick New Jersey United States 08816
    25 Research Site Syracuse New York United States 13210
    26 Research Site Cleveland Ohio United States 44106
    27 Research Site Kettering Ohio United States 45429
    28 Research Site Salem Oregon United States 97301
    29 Research Site Providence Rhode Island United States 02903
    30 Research Site Irving Texas United States 75063
    31 Research Site Bedford Park Australia
    32 Research Site Saint Leonards Australia
    33 Research Site Woolloongabba Australia
    34 Research Site Klagenfurt Austria
    35 Research Site Salzburg Austria
    36 Research Site Brussels Belgium
    37 Research Site Charleroi Belgium
    38 Research Site Gent Belgium
    39 Research Site Roeselare Belgium
    40 Research Site Ronse Belgium
    41 Research Site Yvoir Belgium
    42 Research SIte Hořovice Czechia
    43 Research Site Olomouc Czechia
    44 Research Site Praha 2 Czechia
    45 Research Site Brest France
    46 Research Site Bron France
    47 Research Site Caen France
    48 Research Site Créteil France
    49 Research Site Dijon Cedex France
    50 Research Site Gleizé France
    51 Research Site Limoges cedex France
    52 Research Site Marseille France
    53 Research Site Montpellier France
    54 Research Site Mulhouse France
    55 Research Site Quimper France
    56 Research Site Saint Herblain France
    57 Research Site Strasbourg France
    58 Research Site Villejuif France
    59 Research Site Essen Germany
    60 Research site Gauting Germany
    61 Research Site Großhansdorf Germany
    62 Research Site Halle (Saale) Germany
    63 Research Site Jena Germany
    64 Research Site Kassel Germany
    65 Research Site Löwenstein Germany
    66 Research Site Lübeck Germany
    67 Research Site Oldenburg Germany
    68 Research Site Athens Greece
    69 Research Site Heraklion Greece
    70 Research Site Larissa Greece
    71 Research Site Néa Kifisiá Greece
    72 Research Site Néo Fáliro Greece
    73 Research Site Thessaloníki Greece
    74 Research Site Kowloon Hong Kong
    75 Research Site Shatin Hong Kong
    76 Research Site Budapest Hungary
    77 Research Site Gyöngyös Hungary
    78 Research Site Törökbálint Hungary
    79 Research Site Dublin Ireland
    80 Research Site Galway Ireland
    81 Research Site Alessandria Italy
    82 Research Site Candiolo Italy
    83 Research Site Catania Italy
    84 Research Site Genova Italy
    85 Research Site Lecce Italy
    86 Research Site Meldola Italy
    87 Research Site Milano Italy
    88 Research Site Napoli Italy
    89 Research Site Parma Italy
    90 Research Site Perugia Italy
    91 Research Site Roma Italy
    92 Research Site Busan Korea, Republic of
    93 Research Site Cheongju-si Korea, Republic of
    94 Research Site Daegu Korea, Republic of
    95 Research Site Hwasun Korea, Republic of
    96 Research Site Incheon Korea, Republic of
    97 Research Site Seongnam-si Korea, Republic of
    98 Research Site Seoul Korea, Republic of
    99 Research Site Suwon-si Korea, Republic of
    100 Research Site Lublin Poland
    101 Research Site Otwock Poland
    102 Research Site Rzeszów Poland
    103 Research Site Skorzewo Poland
    104 Research Site Toruń Poland
    105 Research Site Warszawa Poland
    106 Research Site Łódź Poland
    107 Research Site Braga Portugal
    108 Research Site Coimbra Portugal
    109 Research Site Guimarães Portugal
    110 Research Site Lisboa Portugal
    111 Research Site Lisbon Portugal
    112 Research Site Porto Portugal
    113 Research Site Vila Nova De Gaia Portugal
    114 Research Site Chelyabinsk Russian Federation
    115 Research Site Izhevsk Russian Federation
    116 Research Site Kursk Russian Federation
    117 Research Site Moscow Russian Federation
    118 Research Site Nizhniy Novgorod Russian Federation
    119 Research Site Novosibirsk Russian Federation
    120 Research Site Omsk Russian Federation
    121 Research Site Saint Petersburg Russian Federation
    122 Research Site Saint-Petersburg Russian Federation
    123 Research Site Singapore Singapore
    124 Research Site A Coruña Spain
    125 Research Site Badalona Spain
    126 Research Site Barcelona Spain
    127 Research Site Granada Spain
    128 Research Site Lugo Spain
    129 Research Site Madrid Spain
    130 Research Site Malaga Spain
    131 Research Site Palma De Mallorca Spain
    132 Research Site Santander Spain
    133 Research Site Valencia Spain
    134 Research Site Zaragoza Spain
    135 Research Site Basel Switzerland
    136 Research Site Thun Switzerland
    137 Research Site Winterthur Switzerland
    138 Research Site Birmingham United Kingdom
    139 Research Site Edinburgh United Kingdom
    140 Research Site Glasgow United Kingdom
    141 Research Site Leicester United Kingdom
    142 Research Site Manchester United Kingdom

    Sponsors and Collaborators

    • Mirati Therapeutics Inc.

    Investigators

    • Study Director: Julie Meade, MD, Mirati Therapeutics Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mirati Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT04685135
    Other Study ID Numbers:
    • 849-012
    First Posted:
    Dec 28, 2020
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel
    Adagrasib

    Study Results

    No Results Posted as of Aug 12, 2022