Study on Two Dosing Schedules of Adagrasib for Lung Cancer with KRAS G12C Mutation (KRYSTAL 21)

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05853575

Provider View

This clinical trial is testing two different dosing schedules of the drug adagrasib to see which is more effective for patients with non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of two different dosing schedules of adagrasib, a medication for non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. Patients will receive either 600 mg of adagrasib twice a day without food or 400 mg twice a day with food. This study is for patients who have already been treated with chemotherapy and immune checkpoint inhibitors.

Description

This phase 2 study, known as CA239-0012, is investigating the effects of two different dosing schedules of adagrasib in patients with non-small cell lung cancer (NSCLC) that has the KRAS G12C mutation. Participants will be randomly assigned to receive either 600 mg of adagrasib twice daily without regard to food or 400 mg twice daily with food. The study is focused on patients who have previously been treated with a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy. The goal is to determine which dosing schedule is more effective in treating this type of lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation.
  • Have previously received chemotherapy with cisplatin or carboplatin and an immune checkpoint inhibitor.
  • Must have recovered from previous treatments and have safe blood test results.

Exclusion Criteria

  • Have previously been treated with a drug targeting KRAS G12C.
  • Have cancer that can be surgically removed.
  • Have untreated brain lesions larger than 2.0 cm, brainstem lesions, or require more than 10 mg of prednisone daily.
  • Have poorly controlled seizures or worsening neurological symptoms due to brain lesions.
  • Have medical conditions or take medications that could make participation unsafe or difficult, or are pregnant.

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