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Study identifier: NCT07012031 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Locally Advanced Lung Non-Small Cell Carcinoma · Metastatic Lung Non-Small Cell Carcinoma · Stage III Lung Cancer AJCC v8  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1/Phase 2
Planned participants37
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving sotorasib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or effective in treating patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (9)

University of California Davis Comprehensive Cancer CenterSacramento, California, United StatesRecruiting
Moffitt Cancer Center-International PlazaTampa, Florida, United StatesRecruiting
Moffitt Cancer Center - McKinley CampusTampa, Florida, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Moffitt Cancer Center at Wesley ChapelWesley Chapel, Florida, United StatesRecruiting
Case Western Reserve UniversityCleveland, Ohio, United StatesRecruiting
Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesRecruiting
University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, Pennsylvania, United StatesRecruiting
University of Virginia Cancer CenterCharlottesville, Virginia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07012031