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

March 26, 2024 updated by: Mirati Therapeutics Inc.

A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

453

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Bedford Park, Australia
        • Research Site
      • Douglas, Australia
        • Research Site
      • Heidelberg, Australia
        • Research Site
      • Mackay, Australia
        • Research Site
      • Saint Leonards, Australia
        • Research Site
      • Tweed Heads, Australia
        • Research Site
      • Wollongong, Australia
        • Research Site
      • Woolloongabba, Australia
        • Research Site
  • Austria
      • Klagenfurt, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Charleroi, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Roeselare, Belgium
        • Research Site
      • Ronse, Belgium
        • Research Site
      • Yvoir, Belgium
        • Research Site
  • China
      • Beijing, China
        • Research Site
      • Changchun, China
        • Research Site
      • Changsha, China
        • Research Site
      • Chengdu, China
        • Research Site
      • Chongqing, China
        • Research Site
      • Fuzhou, China
        • Research Site
      • Guangxi, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Hangzhou, China
        • Research Site
      • Harbin, China
        • Research Site
      • Jinan, China
        • Research Site
      • Linyi, China
        • Research Site
      • Nanchang, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Qingdao, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Shenyang, China
        • Research Site
      • Wuhan, China
        • Research Site
      • Xiamen, China
        • Research Site
      • Xinxiang, China
        • Research Site
      • Xuzhou, China
        • Research Site
      • Zhengzhou, China
        • Research Site
  • Czechia
      • Hořovice, Czechia
        • Research Site
      • Olomouc, Czechia
        • Research Site
      • Prague, Czechia
        • Research Site
      • Praha 2, Czechia
        • Research Site
  • France
      • Brest, France
        • Research Site
      • Bron, France
        • Research Site
      • Caen, France
        • Research Site
      • Créteil, France
        • Research Site
      • Dijon Cedex, France
        • Research Site
      • Gleizé, France
        • Research Site
      • La Tronche, France
        • Research Site
      • Limoges cedex, France
        • Research Site
      • Marseille, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Mulhouse, France
        • Research Site
      • Nice, France
        • Research Site
      • Quimper, France
        • Research Site
      • Saint Herblain, France
        • Research Site
      • Saint-Priest-en-Jarez, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Tours Cedex 9, France
        • Research Site
      • Villejuif, France
        • Research Site
  • Germany
      • Bad Berka, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Gauting, Germany
        • Research Site
      • Gießen, Germany
        • Research Site
      • Großhansdorf, Germany
        • Research Site
      • Halle (Saale), Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Kassel, Germany
        • Research Site
      • Köln, Germany
        • Research Site
      • Löwenstein, Germany
        • Research Site
      • Lübeck, Germany
        • Research Site
      • Offenbach, Germany
        • Research Site
      • Oldenburg, Germany
        • Research Site
    • Bayern
      • München, Bayern, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Heraklion, Greece
        • Research Site
      • Larissa, Greece
        • Research Site
      • Néa Kifisiá, Greece
        • Research Site
      • Néo Fáliro, Greece
        • Research Site
      • Thessaloníki, Greece
        • Research Site
      • Volos, Greece
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • Kowloon, Hong Kong
        • Research Site
      • Shatin, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Gyöngyös, Hungary
        • Research Site
      • Székesfehérvár, Hungary
        • Research Site
      • Törökbálint, Hungary
        • Research Site
  • Ireland
      • Dublin, Ireland
        • Research Site
      • Galway, Ireland
        • Research Site
      • Limerick, Ireland
        • Research Site
  • Italy
      • Alessandria, Italy
        • Research Site
      • Avellino, Italy
        • Research Site
      • Aviano, Italy
        • Research Site
      • Bari, Italy
        • Research Site
      • Brescia, Italy
        • Research Site
      • Candiolo, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Lecce, Italy
        • Research Site
      • Meldola, Italy
        • Research Site
      • Milan, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Novara, Italy
        • Research Site
      • Parma, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Pesaro, Italy
        • Research Site
      • Ravenna, Italy
        • Research Site
      • Roma, Italy
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Research Site
      • Cheongju-si, Korea, Republic of
        • Research Site
      • Daegu, Korea, Republic of
        • Research Site
      • Hwasun, Korea, Republic of
        • Research Site
      • Incheon, Korea, Republic of
        • Research Site
      • Seongnam-si, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Suwon-si, Korea, Republic of
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Breda, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Utrecht, Netherlands
        • Research Site
  • Poland
      • Lublin, Poland
        • Research Site
      • Otwock, Poland
        • Research Site
      • Rzeszów, Poland
        • Research Site
      • Skorzewo, Poland
        • Research Site
      • Toruń, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
    • Lubelskie
      • Lublin, Lubelskie, Poland
        • Research Site
  • Portugal
      • Almada, Portugal
        • Research Site
      • Braga, Portugal
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Guimarães, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Lisbon, Portugal
        • Research Site
      • Loures, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Santa Maria Da Feira, Portugal
        • Research Site
      • Setúbal, Portugal
        • Research Site
      • Vila Nova De Gaia, Portugal
        • Research Site
  • Romania
      • Baia Mare, Romania
        • Research Site
      • Braşov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj-Napoca, Romania
        • Research Site
      • Constanţa, Romania
        • Research Site
      • Craiova, Romania
        • Research Site
      • Iaşi, Romania
        • Research Site
      • Timişoara, Romania
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Research Site
      • Izhevsk, Russian Federation
        • Research Site
      • Kursk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Omsk, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Saint-Petersburg, Russian Federation
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Spain
      • A Coruña, Spain
        • Research Site
      • Alicante, Spain
        • Research Site
      • Badalona, Spain
        • Research Site
      • Barakaldo, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Girona, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • León, Spain
        • Research Site
      • Lugo, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Palma De Mallorca, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
      • Thun, Switzerland
        • Research Site
      • Winterthur, Switzerland
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
  • United States
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • Long Beach, California, United States, 90813
        • Research Site
      • Santa Rosa, California, United States, 95403
        • Research Site
      • Whittier, California, United States, 90603
        • Research Site
    • Colorado
      • Grand Junction, Colorado, United States, 81502
        • Research Site
      • Lafayette, Colorado, United States, 80026
        • Research Site
      • Lone Tree, Colorado, United States, 80124
        • Research Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Research Site
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Jacksonville, Florida, United States, 32204
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Plantation, Florida, United States, 33322
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Research Site
      • Marietta, Georgia, United States, 30060
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Research Site
      • Indianapolis, Indiana, United States, 46237
        • Research Site
      • Munster, Indiana, United States, 46321
        • Research Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Research Site
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Research Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Research Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Research Site
    • Montana
      • Billings, Montana, United States, 59102
        • Research Site
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Research Site
      • Teaneck, New Jersey, United States, 07666
        • Research Site
    • New York
      • Syracuse, New York, United States, 13210
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Research Site
      • Kettering, Ohio, United States, 45429
        • Research Site
    • Oregon
      • Salem, Oregon, United States, 97301
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Research Site
    • Texas
      • Irving, Texas, United States, 75063
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docetaxel
Drug: Docetaxel
21 day cycles
Other Names:
  • Taxotere
Experimental: MRTX849
Drug: MRTX849
21 day cycles
Other Names:
  • adagrasib
  • KRAZATI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 49 Months
Defined as time from date of randomization to date of death due to any cause.
49 Months
Objective Response Rate (ORR)
Time Frame: 32 Months
Defined as the percent of patients documented to have a confirmed CR or PR.
32 Months
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.
49 Months
1-year Survival Rate
Time Frame: 49 Months
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.
49 Months
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
49 Months
Patient Reported Outcomes (PROs)
Time Frame: 49 Months
To be assessed by Lung Cancer Symptom Scale (LCSS).
49 Months
Quality of LIfe Assessment
Time Frame: 49 Months
To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
49 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirati Therapeutics Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 30, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 849-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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