Study on the Effectiveness and Safety of Divarasib Compared to Immunotherapy or Observation in Patients with Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer

Sponsor: Hoffmann-La Roche

Sponsor score: 40

ClinicalTrials ID:NCT07541170

Provider View

This clinical trial is testing whether the drug divarasib is more effective than standard immunotherapy options or observation in patients with Stage II-III KRAS G12C-positive Non-Small Cell Lung Cancer (NSCLC) who have had surgery but did not achieve complete cancer removal with prior treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug divarasib works better than the usual immunotherapy treatments (pembrolizumab or nivolumab) or just monitoring the patient, in people with Stage II-III KRAS G12C-positive Non-Small Cell Lung Cancer (NSCLC) who have had surgery to remove the cancer but still have some cancer cells left. This study includes patients regardless of their tumor's PD-L1 status.

Eligibility Criteria

Inclusion Criteria

  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of Stage II-IIIB Non-Small Cell Lung Cancer (NSCLC), either non-squamous or squamous type.
  • Have had complete surgical removal of the lung cancer.
  • Have previously received treatment with an immune checkpoint inhibitor (pembrolizumab or nivolumab) along with chemotherapy before surgery.
  • Must join the study within 12 weeks after surgery.
  • Show no signs of cancer returning or spreading.
  • Have a confirmed KRAS G12C mutation in the cancer.

Exclusion Criteria

  • Have achieved complete cancer removal with prior treatments.
  • Have previously been treated with a KRAS inhibitor or other unspecified cancer therapies.
  • Have received radiation therapy for NSCLC, except for localized treatment before surgery.
  • Have unresolved severe side effects from previous immunotherapy.
  • Have an active or past autoimmune disease or immune deficiency.
  • Have significant heart disease.

Locations

FACILITYZIPCITYSTATE
Community Cancer Institute (CCI)93611ClovisCalifornia

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