A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

  • Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Not yet recruiting

This trial runs in
N/A
Trial Identifier:

NCT06497556 2024-510908-37-00 BO45217

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT06497556, BO45217, 2024-510908-37-00 Trial Identifier
      Divarasib, Sotorasib, Adagrasib Treatments
      Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer Condition
      Official Title

      A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Unequivocal histologically or cytologically confirmed diagnosis of unresectable Stage IIIc, per the American Joint Committee on Cancer staging system (AJCC) (Amin et al. 2017) not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
      • Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the metastatic setting
      • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
      • Documentation of the presence of a KRAS G12C mutation
      • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • Life expectancy of >= 12 weeks
      Exclusion Criteria
      • Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
      • Malabsorption syndrome or other condition that would interfere with enteral absorption
      • Known concomitant second oncogenic driver
      • Mixed small-cell lung cancer or large cell neuroendocrine histology
      • Known and untreated, or active central nervous system (CNS) metastases
      • Leptomeningeal disease or carcinomatous meningitis
      • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
      • Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
      • Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
      • More than 30 Gy of radiotherapy to the lung within 6 months of randomization
      • Uncontrolled tumor-related pain
      • Unresolved toxicities from prior anticancer therapy
      • History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

      For the latest version of this information please go to www.forpatients.roche.com

       

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