RecruitingPhase I/IIEN originalLung cancerHER2 positiveMetastatic / advanced

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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjenci, u których zdiagnozowano zaawansowany lub rozsiany rak płuca z mutacją KRAS G12C, który był wcześniej leczony lekiem blokującym mutację KRAS G12C, lekiem wpływającym na układ odpornościowy oraz chemioterapią.
  • Mutacja KRAS G12C musi być potwierdzona w tkance guza lub we krwi.
  • Przed rozpoczęciem badania należy potwierdzić, jaki dokładnie lek blokujący mutację KRAS G12C był wcześniej stosowany i kiedy.
  • Muszą istnieć dane o ostatnim leczeniu, które otrzymał pacjent, i o tym, czy zawierało ono lek blokujący mutację KRAS G12C.
  • Muszą być dostępne informacje o wcześniejszym stanie HER2 guza.
  • Pacjenci muszą mieć obecność mutacji HER2.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 31, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (9)

University of California Davis Comprehensive Cancer Center

Sacramento, United States

Moffitt Cancer Center-International Plaza

Tampa, United States

Moffitt Cancer Center - McKinley Campus

Tampa, United States

Moffitt Cancer Center

Tampa, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, United States

Case Western Reserve University

Cleveland, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

UPMC Hillman Cancer Center

Pittsburgh, United States

University of Virginia Cancer Center

Charlottesville, United States

Trial contact

Site Public Contact

Surbhi Singhal

PRINCIPAL_INVESTIGATOR

Andreas N. Saltos

PRINCIPAL_INVESTIGATOR

Matthew M. Mirsky

PRINCIPAL_INVESTIGATOR

Jacob Kaufman

PRINCIPAL_INVESTIGATOR

Site Public Contact

Liza C. Villaruz

PRINCIPAL_INVESTIGATOR

Richard D. Hall

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.

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