Study Comparing Divarasib with Sotorasib or Adagrasib for Treating Advanced KRAS G12C-positive Lung Cancer

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06497556

This clinical trial is testing the effectiveness and safety of a new drug, divarasib, compared to existing treatments, sotorasib or adagrasib, for patients with advanced or metastatic non-small cell lung cancer that has a specific KRAS G12C mutation.

Patient Parameters

Program Overview

The aim of this study is to evaluate how well the new drug divarasib works and how safe it is compared to other approved treatments, sotorasib or adagrasib, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic mutation called KRAS G12C.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be removed by surgery.
  • The cancer must have worsened during or after one to three previous treatments.
  • Have at least one tumor that can be measured by scans.
  • Have a KRAS G12C mutation in the cancer cells.
  • Be able to provide a sample of the tumor tissue for testing.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.

Exclusion Criteria

  • Have an allergy to divarasib, sotorasib, or adagrasib.
  • Have a condition that affects the absorption of medications in the stomach or intestines.
  • Have another active cancer-causing mutation.
  • Have a mixed type of lung cancer that includes small-cell or large cell neuroendocrine cancer.
  • Have untreated or active cancer that has spread to the brain or spinal cord.
  • Have cancer in the membranes surrounding the brain or spinal cord.
  • Have uncontrolled fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
  • Have an infection that could affect safety or have been treated with antibiotics within 14 days before starting the study.
  • Have previously been treated with any KRAS G12C or pan-KRAS/RAS inhibitors.
  • Have received more than 30 Gy of radiation to the lungs within 6 months before starting the study.
  • Have uncontrolled pain related to the tumor.
  • Have unresolved side effects from previous cancer treatments.
  • Have had another cancer within the last 5 years, except for certain non-threatening cancers.

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