Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation

This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sotorasib blocks a protein made by the mutated KRAS gene (KRAS p.G12C), which may help keep tumor cells from growing and may kill them. It is a type of targeted therapy. Trastuzumab deruxtecan is in a class of medi

Trial Details

NCT ID
NCT07012031
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
Locations (sample)
  • Sacramento, California, United States|38.58157,-121.4944
  • Tampa, Florida, United States|27.94752,-82.45843
  • Tampa, Florida, United States|27.94752,-82.45843
  • Tampa, Florida, United States|27.94752,-82.45843
  • Wesley Chapel, Florida, United States|28.23973,-82.32787

Key Eligibility Criteria

  • Patients must have histologically or cytologically documented locally advanced or metastatic KRAS\^G12C-mutant NSCLC that has previously been treat…
  • Patients must have KRAS\^G12C mutation identified by tumor tissue or plasma circulating tumor deoxyribonucleic acid (ctDNA) profiling using a Clini…
  • Data must be available for which prior KRAS\^G12C inhibitor treatment the patient has received and the dates that they received it (type of KRAS\^G…
  • Data must be available on the date patients received the last dose of KRAS\^G12C inhibitor and the date of disease progression on their last treatm…

For full eligibility, visit ClinicalTrials.gov.

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