Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Last updated: May 30, 2025
Sponsor: Mirati Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Metastatic Cancer

Lung Cancer

Treatment

Adagrasib

Clinical Study ID

NCT05853575
CA239-0012
CA239-0012
849-021
2023-503523-25
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Are at least 18 years old (or old enough to legally make their own treatmentdecisions, according to local laws).

  • Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and thenspread to other parts of the body) with the KRAS G12C mutation.

  • Have had previous treatment with 1) chemotherapy that included a drug calledcisplatin or a drug called carboplatin and 2) a type of drug called an immunecheckpoint inhibitor.

  • Have recovered from their prior treatment and blood tests are within a safe range.

Exclusion

Key Exclusion Criteria:

  • Have had previous treatment with a drug that targets KRAS G12C.

  • Have cancer that can potentially be removed with surgery.

  • Patients with brain lesions are not eligible if 1) any untreated brain lesions are > 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing >10 mgdaily prednisone (or equivalent) and 4) poorly controlled (> 1/week) generalized orcomplex partial seizures or neurologic progression/instability due to brain lesions.

  • Have certain medical conditions or need to take certain medications that, in theopinion of a trial doctor, could make it unsafe for them to participate or difficultto complete the trial assessments, or are pregnant.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Adagrasib
Phase: 2
Study Start date:
February 16, 2024
Estimated Completion Date:
July 30, 2026

Study Description

CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.

Connect with a study center

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    Belo Horizonte, Minas Gerais 30360680
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  • Clinica de Neoplasias Litoral

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  • AMO Assistencia Multidisciplinar em Oncologia

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    Pula, Istarska Županija 52100
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    Edirne, 22030
    Turkey

    Active - Recruiting

  • Trakya Universitesi Hastanesi Ic Hastaliklari Anabilim Dali Tibbi Onkoloji

    Edirne,
    Turkey

    Active - Recruiting

  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Tibbi Onkoloji

    Istanbul,
    Turkey

    Active - Recruiting

  • Goztepe SuleymanYalcin Sehir Hast

    Istanbul, 34722
    Turkey

    Active - Recruiting

  • Istanbul Onkoloji Hastanesi Tibbi Onkoloji

    Istanbul, 34846
    Turkey

    Active - Recruiting

  • Local Institution - 709

    Istanbul, 34214
    Turkey

    Site Not Available

  • Medipol Mega Universite Hastanesi Tibbi Onkoloji

    Istanbul, 34214
    Turkey

    Active - Recruiting

  • Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722
    Turkey

    Active - Recruiting

  • Ege Universitesi Hastanesi Ic Hastaliklari Anabilim Dali Onkoloji Bilim Dali

    Izmir, 35100
    Turkey

    Active - Recruiting

  • Ege University Medical Faculty - Pulmonary

    Izmir, 35100
    Turkey

    Active - Recruiting

  • Local Institution - 708

    Izmir, 35100
    Turkey

    Site Not Available

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Providence Medical Foundation - Research

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Local Institution - 104

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Local Institution - 106

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Local Institution - 103

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Kansas City VA Hospital

    Kansas City, Missouri 64128
    United States

    Active - Recruiting

  • Kansas City VA Medical Center

    Kansas City, Missouri 64128
    United States

    Active - Recruiting

  • Local Institution - 105

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • Durham VA Medical Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Veterans Affairs Medical Center (VAMC) - Durham

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Veterans Affairs Medical Center (VAMC) - Durham - Oncology

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • VA North Texas Healthcare System/Dallas VA Medical Center

    Dallas, Texas 75216-7167
    United States

    Active - Recruiting

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