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

Last updated: April 16, 2025
Sponsor: Mirati Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Neoplasm Metastasis

Metastatic 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.

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