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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

Status
Approved-not yet active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06497556
Protocol IDs
BO45217 (primary)
NCI-2024-06076
2024-510908-37-00
Study Sponsor
Hoffmann-La Roche

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).

Eligibility

  1. 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
  2. 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
  3. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  4. Documentation of the presence of a KRAS G12C mutation
  5. 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
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  7. Life expectancy of >= 12 weeks
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.